Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard PCR assay and automated system for detecting specific pathogens. There is no mention of AI or ML being used for data analysis, interpretation, or system control beyond standard automation.

Therapeutic

No
The Alinity m STI Assay is an in vitro diagnostic device used for the qualitative detection and differentiation of specific pathogens to aid in the diagnosis of disease, not to treat it.

Diagnostic

Yes

Justification: The "Intended Use / Indications for Use" section explicitly states that the assay is "to aid in the diagnosis of disease(s) caused by infection from these organisms." This directly indicates its role as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic (IVD) assay that requires specific reagents, controls, and is used with the Alinity m System, which is a hardware analyzer. While software is part of the Alinity m System, the device itself is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay. It is used for the direct, qualitative detection and differentiation of specific organisms to aid in the diagnosis of disease(s). This clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
Device Description: The description details how the assay works by analyzing nucleic acids extracted from human specimens (vaginal swabs, urine, etc.) using laboratory procedures (PCR amplification and detection). This is characteristic of an in vitro diagnostic test.
Specimen Types: The assay is designed to test various human specimens, which is a key feature of IVDs.
Clinical Performance Studies: The document includes detailed information about clinical performance studies using human specimens to evaluate the assay's accuracy (sensitivity, specificity, etc.) in aiding diagnosis. This is a regulatory requirement for IVDs.
Predicate Devices: The mention of predicate devices (other commercially available IVD assays for similar purposes) further confirms its classification as an IVD.

In summary, the Alinity m STI Assay meets the criteria of an In Vitro Diagnostic device based on its intended use, the type of analysis performed on human specimens, and the regulatory context indicated by the performance studies and predicate devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes:

CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs

NG: vaginal swabs (clinician-collected and self-collected in a clinical setting). endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs

TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine

MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine

A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.

The Alinity m multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female urine specimens, endocervical swab specimens, vaginal swab specimens, oropharyngeal swab specimens, and rectal swab specimens to stabilize nucleic acid for testing with the Alinity m STI Assay. Refer to the Alinity m STI Assay package insert for additional information.

The Alinity m multi-Collect Specimen Collection Kit is not intended for home use.

Product codes

QEP, MKZ, LSL, OUY, LIO, OOI

Device Description

The Alinity m STI Assay is a real time polymerase chain reaction (PCR) assay for the amplification and detection of Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhea (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences. The assay can be used with endocervical swab specimens, vaginal swab specimens, male and female urine specimens, gynecological specimens in ThinPrep® PreservCyt® Solution, oropharyngeal swab specimens, and rectal swab specimens. Endocervical swab, vaginal swab, oropharyngeal swab, rectal swab and urine specimens are collected with the Alinity m multi-Collect Specimen Collection Kit. PreservCyt Solution specimens are transferred to an Alinity m Transport Tube for processing on the Alinity m System.

The steps of the Alinity m STI Assay consist of sample preparation, RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI Assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI Assay in parallel with other Alinity m assays on the same instrument.

The Alinity m STI Assay requires two separate assay specific kits as follows:

Alinity m STI AMP Kit, List No. 09N17-095 consisting of multi-well amplification plates containing lyophilized, unit-dose PCR amplification/detection reagents and multi-well activator plates containing liquid, unit-dose activation reagents (MgCl2, TMAC, and KCl). The intended storage condition for the Alinity m STI AMP Kit is 2℃ to 8℃.
Alinity m STI CTRL Kit, List No. 09N17-085 consisting of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C.

Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash and elution. The resulting purified nucleic acids are then combined with the liquid unit-dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection.

Assay controls are tested at or above an established minimum frequency of every 24 hours to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The controls do not indicate if bacterial cells have been adequately lysed.

The Alinity m STI amplification reagents include primers and a probe that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents to assess amplification efficiency and to confirm that no PCR inhibitors are present in the sample. The cellular control and internal control are both used to demonstrate assay validity.

The Alinity m STI Assay also utilizes the following accessories:

Alinity m STI Assay Application Specification File, List No. 09N17-03A
Alinity m System and System Software, List No. 08N53-002
Alinity m Sample Prep Kit 1, List No. 09N18-001
Alinity m multi-Collect Specimen Collection Kit, List No. 09N19-010
Alinity m Tubes and Caps, List No. 09N49:
- Alinity m Transport Tubes Pierceable Capped, List No. 09N49-010
- Alinity m Transport Tube, List No. 09N49-011
- Alinity m Pierceable Cap, List No. 09N49-012
Alinity m System Solutions, List No. 09N20:
- Alinity m Lysis Solution, List No. 09N20-001
- Alinity m Ethanol Solution, List No. 09N20-002
- Alinity m Diluent Solution, List No. 09N20-003
- Alinity m Vapor Barrier Solution, List No. 09N20-004

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vagina, endocervix, male urine, oropharynx, rectum, gynecological specimens in ThinPrep PreservCyt Solution

Indicated Patient Age Range

14 years of age or older

Intended User / Care Setting

STI clinics, primary care offices, gynecology practices. No intermediate processing or transfer steps are performed by the user.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Urogenital Specimens:

Sample size: 7,099 male and female, asymptomatic and symptomatic subjects. A total of 12,903 CT, 15,655 NG, 18,843 TV, and 12,829 MG results were used in the analysis.
Data source: Clinical study conducted in the United States at 33 geographically diverse sites.
Annotation protocol: For female subjects, a Patient Infected Status (PIS) was determined:
- CT/NG: A minimum of 2 positive results (at least 1 from each comparator NAAT) for infection. At least 1 comparator NAAT reported negative results for all sample types for not infected.
- TV/MG: Two positive swab comparator NAAT results or 2 of 3 positive if 3rd NAAT was a tie-breaker for infection. Two negative swab comparator NAAT results or 2 of 3 negative if 3rd NAAT was a tie-breaker for not infected.
- Specimen-specific agreement for female urine for TV: Positive if at least 1 comparator NAAT was positive; Negative if both comparator NAATs were negative.
For male subjects, a PIS was determined:
- CT/NG/TV/MG: A minimum of two comparator positive results for infection. If the comparator TV culture assay result was positive, the subject was categorized as infected for TV regardless of NAAT results. Not infected for CT/NG/MG if two or more comparator NAAT results were negative. For TV, not infected if TV culture assay result was negative and one or more comparator NAATs were negative.
Subjects were excluded if PIS could not be determined due to missing/indeterminate comparator results (171 subjects for 1 or more analytes: 42 CT, 32 NG, 73 TV, 93 MG).

Extragenital Specimens:

Sample size: 2,373 male and female, asymptomatic and symptomatic subjects. A total of 2,316 CT and 2,312 NG results from oropharyngeal specimens, and 2,053 CT and 2,049 NG results from rectal specimens were used.
Data source: Multicenter clinical study conducted in the United States using archived specimens with IRB/IEC approved consent.
Annotation protocol: An anatomic site-specific composite comparator (CC) was established using 3 commercially available CT/NG NAAT comparator assays.
- Infected: A minimum of 2 comparator positive results.
- Not infected: A minimum of 2 comparator negative results.
Specimens were excluded if CC could not be determined due to missing/indeterminate comparator results (6 oropharyngeal and 8 rectal for CT; 10 oropharyngeal and 6 rectal for NG).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Sensitivity (Limit of Detection - LoD):

Urogenital Specimens:
- CT: 17.0 Elementary Bodies (EB)/mL
- NG: 7.5 Colony Forming Units (CFU)/mL
- TV: 0.1 TV/mL
- MG: 165 Genome Equivalents (GE)/mL
Extragenital Specimens:
- CT: 17.0 EB/mL
- NG: 7.5 CFU/mL

Inclusivity: Confirmed analytical sensitivity by testing various strains of CT (15 serovars), NG (28 isolates), TV (3 strains), and MG (6 strains) at or below claimed LoD, with ≥95.0% detection across relevant matrices.

Evaluation of Potential Cross Reacting Microorganisms:

Urogenital Specimens: 71 microorganisms tested; no cross-reactivity observed. Subset (indicated by asterisk) also assessed in positive samples, with no interference observed.
Extragenital Specimens: 56 additional microorganisms tested; no cross-reactivity observed. Subset (indicated by asterisk) also assessed in positive samples, with no interference observed.

Evaluation of Potential Interfering Substances:

Urogenital Specimens: 35 substances tested at specified concentrations. No interference observed, except for cycle number delays with seminal fluid (>3.0% in PreservCyt), γ-globulin, and glucose in urine and seminal fluid, mucus, and Preparation H Hemorrhoidal Cream in PreservCyt; these could result in interference at lower target levels.
Extragenital Specimens: 18 substances tested. No interference observed, except for cycle number delays with Sensodyne Repair & Protect Sensitive Toothpaste in oropharyngeal specimens and feces in rectal specimens; these could result in interference at lower target levels.

Competitive Interference Study:

Performance challenged with CT, NG, TV, or MG at 3 times LoD in presence of high concentrations of other organisms.
100% detection (20/20 replicates) for each analyte at low concentration in each matrix.

Within Laboratory Precision:

Sample size: 144 replicates per panel member (2 replicates, twice daily for 12 days, on 3 Alinity m Systems with 3 reagent lots by 3 operators).
Study type: Laboratory precision study using panel members at sub-LoD, LoD, low positive, high positive, and negative target levels in urine, swab, and PreservCyt matrices.
Key results: SD and %CV for mean cycle number (CN) reported for various conditions, showing good precision. Detection agreement for positive panels was 100.0%, and for negative panels was 99.8% for CT, 100.0% for NG, 99.7% for TV, and 100.0% for MG. Agreement for sub-LoD panels ranged from 52.8% to 61.1% for CT, 45.1% to 82.6% for NG, 23.6% to 93.8% for TV, and 65.3% to 77.1% for MG.

Carryover:

Study type: Carryover rate determination by testing alternating replicates of high positive and negative samples.
Sample size: 548 negative samples.
Key results: Overall carryover rate for CT was 0.2% (1/548), for TV was 0.4% (2/548), and for NG and MG was 0.0% (0/548). Overall sample carryover rate was 0.4% (2/548).

Reproducibility Study:

Sample size: 150 replicates per panel member (5 replicates on 5 non-consecutive days, across 3 clinical sites, using 3 reagent lots and different control/sample prep kits).
Study type: Multi-site reproducibility study using panel members at sub-LoD, LoD, low positive, high positive, and negative target levels in urine, swab, and PreservCyt matrices.
Key results: Total SD and %CV for clinical sites reported. Agreement for positive panels was 100.0% across most conditions for CT, NG, TV, and MG. Negative panel agreement was 99.2%-100.0%. Sub-LoD agreement varied (e.g., CT: 36.0%-36.0%, NG: 9.3%-53.3%, TV: 29.3%-49.3%, MG: 36.7%-68.0%).

Clinical Performance - Urogenital Specimens:

Study type: Multicenter clinical study.
Sample size: 7,099 subjects; 12,903 CT, 15,655 NG, 18,843 TV, and 12,829 MG results.
Key results (Sensitivities and Specificities by Gender, Specimen Type, and Symptom Status):

CT:
- Female Vaginal Swab (Clinician-Collected): Sensitivity 98.0%, Specificity 99.2% (All subjects)
- Female Vaginal Swab (Self-Collected): Sensitivity 98.5%, Specificity 99.3% (All subjects)
- Female Endocervical Swab: Sensitivity 94.5%, Specificity 99.4% (All subjects)
- Male Urine: Sensitivity 97.2%, Specificity 99.5% (All subjects)
NG:
- Female Vaginal Swab (Clinician-Collected): Sensitivity 100.0%, Specificity 99.8% (All subjects)
- Female Vaginal Swab (Self-Collected): Sensitivity 100.0%, Specificity 99.7% (All subjects)
- Female Endocervical Swab: Sensitivity 92.5%, Specificity 99.8% (All subjects) (Note: 3 FN related to insufficient cellular material)
- Female PreservCyt: Sensitivity 94.4%, Specificity 100.0% (All subjects)
- Male Urine: Sensitivity 100.0%, Specificity 99.9% (All subjects)
TV:
- Female Vaginal Swab (Clinician-Collected): Sensitivity 99.7%, Specificity 97.2% (All subjects)
- Female Vaginal Swab (Self-Collected): Sensitivity 99.4%, Specificity 97.8% (All subjects)
- Female Endocervical Swab: Sensitivity 97.7%, Specificity 96.9% (All subjects)
- Female PreservCyt: Sensitivity 95.6%, Specificity 99.4% (All subjects)
- Male Urine: Sensitivity 98.7%, Specificity 99.2% (All subjects)
- Female Urine (Specimen-specific agreement): Positive Percent Agreement (PPA) 97.7%, Negative Percent Agreement (NPA) 99.1% (All subjects)
MG:
- Female Vaginal Swab (Clinician-Collected): Sensitivity 98.1%, Specificity 99.2% (All subjects)
- Female Vaginal Swab (Self-Collected): Sensitivity 95.4%, Specificity 98.6% (All subjects)
- Female Endocervical Swab: Sensitivity 82.8%, Specificity 99.2% (All subjects)
- Male Urine: Sensitivity 98.1%, Specificity 97.5% (All subjects)

Clinical Performance - Extragenital Specimens:

Study type: Multicenter clinical study.
Sample size: 2,373 subjects; 2,316 CT and 2,312 NG results from oropharyngeal specimens, and 2,053 CT and 2,049 NG results from rectal specimens.
Key results (Sensitivities and Specificities by Specimen Type and Symptom Status):

CT:
- Oropharyngeal: Sensitivity 93.3%, Specificity 99.9% (All subjects)
- Rectal: Sensitivity 94.5%, Specificity 99.6% (All subjects)
NG:
- Oropharyngeal: Sensitivity 95.2%, Specificity 99.3% (All subjects)
- Rectal: Sensitivity 97.1%, Specificity 99.5% (All subjects)

Prevalence Rates (Alinity m STI Assay positivity):

CT: 6.7%-8.4% for various urogenital specimen types; 1.3% (oropharyngeal) - 7.1% (rectal) for extragenital.
NG: 1.3%-3.1% for various urogenital specimen types; 5.0% (oropharyngeal) - 5.5% (rectal) for extragenital.
TV: 10.0%-12.6% for various female urogenital specimen types, 3.0% for male urine.
MG: 7.5%-9.2% for female urogenital specimen types, 8.4% for male urine.

Positive and Negative Predictive Values (PPV and NPV) for Hypothetical Prevalence Rates:

Tables provided for CT, NG, TV, and MG for urogenital and extragenital specimens show how PPV and NPV vary with prevalence. E.g., for CT (CCV): PPV ranges from 36.9% (0.5% prevalence) to 98.0% (30.0% prevalence), while NPV remains high (99.2%-100.0%).

Conclusion: The analytical and clinical study results demonstrate that the Alinity m STI Assay on the Alinity m System performs comparably to the predicate devices in detecting Chlamydia trachomatis, Neisseria gonorrhea, Trichomonas vaginalis, and Mycoplasma genitalium microorganisms that cause sexually transmitted infections and support a substantial equivalence decision.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" for detailed metrics.

Predicate Device(s)

K140354 (Abbott RealTime CT/NG), K190515 (Aptima Combo 2 Assay), K151589 (BD Max CT/GC/TV), DEN180047 (Aptima Mycoplasma genitalium Assay)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).

(a)
Identification. A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) and their associated resistance markers in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist that are not detected by the device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate;
(iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) Limiting statements indicating that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(D) If appropriate (
e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type; and(v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that:
(A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present;
(B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora;
(C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and
(D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy.
(4) Design verification and validation must include:
(i) Detailed device description documentation, including methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (
e.g., how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate.
(iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses.
(iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 29, 2022

Abbott Molecular, Inc. Stacy Ferguson Associate Director Regulatory Affairs 1300 E. Touhy Des Plains, Illinois 60018

Re: K202977

Trade/Device Name: Alinity m STI Assay Regulation Number: 21 CFR 866.3393 Regulation Name: Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) Regulatory Class: Class II Product Code: QEP, MKZ, LSL, OUY, LIO, OOI Dated: February 11, 2022 Received: February 14, 2022

Dear Stacy Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5: 510(k) Summary


5.0		510(k) Summary
	5.1		Submitter
	5.2		Device Information
	5.3		Predicate Devices
	5.4		Device Description
	5.5		Intended Use
	5.6		Similarities and Differences to Predicate Devices
	5.7		Performance Data
		5.7.1	Specific Performance Characteristics
			5.7.1.1 Analytical Sensitivity
			5.7.1.2 Inclusivity
			5.7.1.3 Evaluation of Potential Cross Reacting Microorganisms 14
			5.7.1.4 Evaluation of Potential Interfering Substances 19
			5.7.1.5 Competitive Interference Study
			5.7.1.6 Within Laboratory Precision
			5.7.1.7 Carryover
			5.7.1.8 Reproducibility Study
		5.7.2	Clinical Performance
			5.7.2.1 Clinical Study Results - Urogenital Specimens 35
			5.7.2.2 Clinical Study Results - Extragenital Specimens 65
	5.8		Conclusions Drawn from the Studies

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5.0 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR Section 807.92(c).

Submitter 5.1

| Applicants Name and Address: | Abbott Molecular Inc.
1300 E. Touhy Ave
Abbott Molecular Inc. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stacy Ferguson
Director Regulatory Affairs
Abbott Molecular, Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018
Phone: 224-361-7449
Fax: 224-361-7269 |
| Date Prepared: | April 14, 2022 |

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| Trade Name | Regulation Name | Product
Code | Regulation
Number | Class |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------|-------|
| Alinity m STI Assay | Device to detect nucleic acids from
non-viral microorganism(s) causing
sexually transmitted infections and
associated resistance marker(s) | QEP | 866.3393 | II |

5.2 Device Information

5.3 Predicate Devices

Device Name	Predicate Device	510(k)
Alinity m STI Assay	Abbott RealTime CT/NG
(Primary Predicate for CT/NG)	K140354	5/9/14
Aptima Combo 2 Assay	Aptima Combo 2 Assay
(Primary Predicate for CT/NG)	K190515	5/23/19
BD Max CT/GC/TV	BD Max CT/GC/TV
(Primary Predicate for TV)	K151589	9/6/16
Aptima Mycoplasma genitalium Assay	Aptima Mycoplasma genitalium Assay
(Primary Predicate for MG)	DEN180047	1/23/19

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5.4 Device Description

The Alinity m STI Assay is a real time polymerase chain reaction (PCR) assay for the amplification and detection of Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhea (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences. The assay can be used with endocervical swab specimens, vaginal swab specimens, male and female urine specimens, gynecological specimens in ThinPrep® PreservCyt® Solution, oropharyngeal swab specimens, and rectal swab specimens. Endocervical swab, vaginal swab, oropharyngeal swab, rectal swab and urine specimens are collected with the Alinity m multi-Collect Specimen Collection Kit. PreservCyt Solution specimens are transferred to an Alinity m Transport Tube for processing on the Alinity m System.

The steps of the Alinity m STI Assay consist of sample preparation, RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI Assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI Assay in parallel with other Alinity m assays on the same instrument.

The Alinity m STI Assay requires two separate assay specific kits as follows:

. Alinity m STI AMP Kit, List No. 09N17-095 consisting of multi-well amplification plates containing lyophilized, unit-dose PCR amplification/detection reagents and multi-well activator plates containing liquid, unit-dose activation reagents (MgCl2, TMAC, and KCl). The intended storage condition for the Alinity m STI AMP Kit is 2℃ to 8℃.
. Alinity m STI CTRL Kit, List No. 09N17-085 consisting of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C.

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Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash and elution. The resulting purified nucleic acids are then combined with the liquid unit-dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection.

Assay controls are tested at or above an established minimum frequency of every 24 hours to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The controls do not indicate if bacterial cells have been adequately lysed.

The Alinity m STI amplification reagents include primers and a probe that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents to assess amplification efficiency and to confirm that no PCR inhibitors are present in the sample. The cellular control and internal control are both used to demonstrate assay validity.

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The Alinity m STI Assay also utilizes the following accessories:

. Alinity m STI Assay Application Specification File, List No. 09N17-03A
. Alinity m System and System Software, List No. 08N53-002
Alinity m Sample Prep Kit 1, List No. 09N18-001 .
Alinity m multi-Collect Specimen Collection Kit, List No. 09N19-010 .
. Alinity m Tubes and Caps, List No. 09N49:
- Alinity m Transport Tubes Pierceable Capped, List No. 09N49-010 .
- . Alinity m Transport Tube, List No. 09N49-011
- Alinity m Pierceable Cap, List No. 09N49-012 .
Alinity m System Solutions, List No. 09N20: .
- Alinity m Lysis Solution, List No. 09N20-001 .
- Alinity m Ethanol Solution, List No. 09N20-002 .
- Alinity m Diluent Solution, List No. 09N20-003
- Alinity m Vapor Barrier Solution, List No. 09N20-004 •

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5.5 Intended Use

Alinity m STI AMP Kit:

The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes:

CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs

NG: vaginal swabs (clinician-collected and self-collected in a clinical setting). endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs

TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine

MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine

A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.

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Alinity m multi-Collect Specimen Collection Kit:

The Alinity m multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female urine specimens, endocervical swab specimens, vaginal swab specimens, oropharyngeal swab specimens, and rectal swab specimens to stabilize nucleic acid for testing with the Alinity m STI Assay. Refer to the Alinity m STI Assay package insert for additional information.

The Alinity m multi-Collect Specimen Collection Kit is not intended for home use.

5.6 Similarities and Differences to Predicate Devices

The primary functional components of the Alinity m STI Assay are substantially equivalent to other legally marketed nucleic acid amplification tests (NAAT) intended for the qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG).

The Alinity m STI Assay has the same general intended use as the predicate devices. Although there are some technological differences between the Alinity m STI Assay and the predicate devices, these differences do not raise new types of safety or effectiveness questions.

These devices are similar in that they are designed to prepare nucleic acids for amplification, amplify specific CT, NG, TV, and MG sequences, detect the amplified products, and report qualitative results.

The primary similarities and differences between the Alinity m STI Assay and the NAAT predicate devices are shown in Table 1. The primary similarities and differences between the Alinity m multi-Collect Specimen Collection Kit and the predicate device are shown in .

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Table 1. Similarities and Differences Between Alinity m STI Assay and Nucleic Acid Amplification Tests-Predicate Devices
Feature	Current Application	Predicate Devices
	Alinity m STI Assay	Abbott RealTime CT/NG
(Predicate for CT/NG)	Aptima Combo 2 Assay
(Predicate for CT/NG)	Becton Dickinson
MAX CT/GC/TV
(Predicate for TV)	Aptima Mycoplasma genitalium
Assay
(Predicate for MG)
Intended Use	The Alinity m STI Assay is an in
vitro polymerase chain reaction
(PCR) assay for use with the
automated Alinity m System for
the direct, qualitative detection
and differentiation of ribosomal
RNA from Chlamydia
trachomatis (CT), DNA from
Neisseria gonorrhoeae (NG),
ribosomal RNA from
Trichomonas vaginalis (TV), and
ribosomal RNA from
Mycoplasma genitalium (MG) to
aid in the diagnosis of urogenital
disease(s) caused by infection
from these organisms. The assay
may be used to test the following
specimens from symptomatic and
asymptomatic individuals for the
following analytes:
CT: vaginal swabs (clinician-
collected and self-collected in a
clinical settings), endocervical
swabs, male urine, oropharyngeal
swabs, and rectal swabs
NG: vaginal swabs (clinician-
collected and self-collected in a
clinical settings), endocervical
swabs, gynecological specimens
in ThinPrep PreservCyt Solution,
male urine, oropharyngeal swabs,
and rectal swabs
TV: vaginal swabs (clinician-
collected and self-collected in a	The Abbott RealTime CT/NG assay
is an in vitro polymerase chain
reaction (PCR) assay for the direct,
qualitative detection of the plasmid
DNA of Chlamydia trachomatis
and the genomic DNA of Neisseria
gonorrhoeae. The assay may be
used to test the following
specimens from symptomatic
individuals: female endocervical
swab, clinician-collected vaginal
swab, patient-collected vaginal
swab specimens; male urethral
swab specimens; and female and
male urine specimens. The assay
may be used to test the following
specimens from asymptomatic
individuals: clinician-collected
vaginal swab and patient-collected
vaginal swab specimens; female
and male urine specimens.	The Aptima Combo 2 Assay is a
target amplification nucleic acid
probe test that utilizes target capture
for the in vitro qualitative detection
and differentiation of ribosomal
RNA (rRNA) from Chlamydia
trachomatis (CT) and/or Neisseria
gonorrhoeae (GC) to aid in the
diagnosis of chlamydial and/or
gonococcal disease using the Panther
System as specified.
On the Panther System, the assay
may be used to test the following
specimens from symptomatic and
asymptomatic individuals: clinician-
collected endocervical, vaginal,
throat, rectal, and male urethral swab
specimens, clinician-collected
gynecological specimens collected in
the PreservCyt Solution, patient-
collected vaginal swab specimens,1
and female and male urine
specimens.
Patient-collected vaginal swab
specimens are an option for
screening women when a pelvic
exam is not otherwise indicated. The
Aptima Multitest Swab Specimen
Collection kit has not been evaluated
for home use.	The BD MAX CT/GC/TV assay, as
performed using the BD MAX
System incorporates automated
DNA extraction and real-time
polymerase chain reaction (PCR)
for the direct, qualitative detection
of DNA from Chlamydia
trachomatis (CT), Neisseria
gonorrhoeae (GC) and/or
Trichomonas vaginalis (TV). The
assay may be used for detection of
CT and/or GC DNA in male urine
specimens, and the detection of CT,
GC and/or TV DNA in female
urine specimens, clinician-collected
female endocervical swab
specimens and patient-collected
vaginal swab specimens (in a
clinical setting). The assay is
indicated for use to aid in the
diagnosis of chlamydial urogenital
disease, gonococcal urogenital
disease and/or trichomoniasis in
asymptomatic and symptomatic
individuals.	The Aptima Mycoplasma genitalium
assay is an in vitro nucleic acid
amplification test (NAAT) for the
qualitative detection of ribosomal
RNA (rRNA) from Mycoplasma
genitalium on the fully automated
Panther system. It is intended for use
as an aid in the diagnosis of M.
genitalium urogenital infections in
male and female patients suspected of
M. genitalium infection.
The assay may be used to test the
following specimens: clinician-
collected and self-collected vaginal
swabs (in a clinical setting), clinician-
collected endocervical swabs, female
and male urine, clinician-collected
male urethral swabs, and self-
collected penile meatal swabs (in a
clinical setting).
For females, a vaginal swab is the
preferred specimen type due to higher
clinical sensitivity for detecting M.
genitalium than other specimen types;
however, female urine or clinician-
collected endocervical swabs may be
used as alternative specimens when
vaginal swab specimens are not
available. If female urine or clinician-
collected endocervical swab
specimens test negative, testing with a
vaginal swab may be indicated, if M.
genitalium infection is suspected.
Feature	Current Application	Predicate Devices
	Alinity m STI Assay	Abbott RealTime CT/NG
(Predicate for CT/NG)	Aptima Combo 2 Assay
(Predicate for CT/NG)	Becton Dickinson
MAX CT/GC/TV
(Predicate for TV)	Aptima Mycoplasma genitalium
Assay
(Predicate for MG)
	clinical settings), endocervical
swabs, gynecological specimens
in ThinPrep PreservCyt Solution,
female urine, and male urine
	MG : vaginal swabs (clinician
collected and self-collected in a
clinical settings), endocervical
swabs, and male urine
	A vaginal swab (self-collected or
clinician-collected) is the
preferred specimen type for MG
testing in females due to higher
clinical sensitivity compared to
endocervical swabs. If
endocervical swab specimens test
negative, testing with a vaginal
swab may be indicated if M.
genitalium infection is suspected.
Table 1. Similarities and Differences Between Alinity m STI Assay and Nucleic Acid Amplification Tests-Predicate Devices
Feature	Current Application	Predicate Devices
	Alinity m STI Assay	Abbott RealTime CT/NG
(Predicate for CT/NG)	Aptima Combo 2 Assay
(Predicate for CT/NG)	Becton Dickinson
MAX CT/GC/TV
(Predicate for TV)	Aptima Mycoplasma genitalium
Assay
(Predicate for MG)
Assay Type	Qualitative	Qualitative	Qualitative	Qualitative	Qualitative
Assay Targets	CT ribosomal RNA	CT cryptic plasmid DNA	CT ribosomal RNA	CT genomic DNA	NA
	NG genomic DNA	NG genomic DNA	NG ribosomal RNA	NG genomic DNA	NA
	TV ribosomal RNA	NA	NA	TV genomic DNA	NA
	MG ribosomal RNA	NA	NA	NA	MG ribosomal RNA
Specimen Types	Endocervical swab	Endocervical swab	Endocervical swab	Endocervical swab	Endocervical swab
	Self-collected vaginal swab	Self-collected vaginal swab	Self-collected vaginal swab	Self-collected vaginal swab	Self-collected vaginal swab
	Clinician-collected vaginal
swab	Clinician-collected vaginal
swab	Clinician-collected vaginal swab	NA	Clinician-collected vaginal swab
	Male and female urine	Male and female urine	Male and female urine	Male urine (for CT and NG
only ) and female urine (CT,
NG and TV)	Male and female urine
	NA	Male urethral swabs	Male urethral swab	NA	Male urethral swab
	Gynecological specimens in
PreservCyt Solution	NA	Gynecological specimens in
PreservCyt Solution	NA	NA
	NA	NA	NA	NA	Self-collected penile meatal
swabs (in a clinical setting)
	Oropharyngeal swab	NA	Oropharyngeal swab	NA	NA
	Rectal swab	NA	Rectal swab	NA	NA
Table 1. Similarities and Differences Between Alinity m STI Assay and Nucleic Acid Amplification Tests-Predicate Devices
Feature	Current Application	Predicate Devices
	Alinity m STI Assay	Abbott RealTime CT/NG
(Predicate for CT/NG)	Aptima Combo 2 Assay
(Predicate for CT/NG)	Becton Dickinson
MAX CT/GC/TV
(Predicate for TV)	Aptima Mycoplasma genitalium
Assay
(Predicate for MG)
Sample
Preparation
Procedure	Automated	Automated	Automated	Automated	Automated
Amplification
Technology	Real-Time Polymerase Chain
Reaction (PCR)	Real-Time PCR	Target Capture (TC),
Transcription-mediated
Amplification (TMA),
Dual Kinetic Assay (DKA)	Real-Time PCR	Target Capture (TC),
Transcription-mediated
Amplification (TMA),
Hybridization Protection Assay
(HPA)
Assay Controls	Negative Control Positive Control Internal Control (IC) Cellular Control (CC)	Negative Control Cutoff Control Internal Control (IC)	CT Positive/NG Negative Control CT Negative/NG Positive Control	No Negative Control No Positive Control Sample Processing Control	No Negative Control No Positive Control Internal Control (IC)

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13

14

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5.7 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Specific Performance Characteristics 5.7.1

5.7.1.1 Analytical Sensitivity

Urogenital Specimens

The limit of detection (LoD) for urogenital specimens was determined by testing dilutions of CT, NG, TV, and MG organisms in pooled negative vaginal swab matrix, pooled negative gynecological PreservCyt matrix, and pooled negative urine matrix. Two different strains were evaluated for each organism in each matrix: serovars D and E for CT (ATCC), strains Z437 and Z433 for NG (Zeptometrix), strains 30001 (ATCC) and MTZ (metronidazole-resistant, Zeptometrix) for TV, and strains SEA-1 and MEGA 216 (azithromycin-resistant) for MG (non-commercial source). For each strain and matrix, a minimum of 6 target levels were evaluated in at least 20 replicates using each of 2 lots. Probit analysis was performed to estimate the LoD for each strain and matrix for each lot. In cases where the probit model did not fit the data, the LoD was determined for each lot to be the target concentration with a detection rate 95% or greater.

The LoD claim for the Alinity m STI Assay is as follows for each of the organisms in urogenital specimen types:

CT: 17.0 Elementary Bodies (EB)/mL .
NG: 7.5 Colony Forming Units (CFU)/mL .
. TV: 0.1 TV/mL
. MG: 165 Genome Equivalents (GE)/mL

Extragenital Specimens

The LoD for extragenital specimens was determined by testing dilutions of CT and NG organisms in pooled negative oropharyngeal swab matrix and pooled negative rectal

16

swab matrix. Two different strains were evaluated for each organism in each matrix: serovars D and E for CT (ATCC) and strains Z437 and Z433 (Zeptometrix) for NG. For each strain and matrix, a minimum of 3 target levels were evaluated in 20 replicates using one reagent lot. The LoD level was determined to be the concentration with a detection rate of 95% or greater where the target level 2-fold below was less than 95%.

The LoD claim for the Alinity m STI Assay is as follows for each of the organisms in extragenital specimen types:

. CT: 17.0 EB/mL
. NG: 7.5 CFU/mL

5.7.1.2 Inclusivity

The analytical sensitivity claim of the Alinity m STI Assay was confirmed by testing at least 20 replicates of the following additional strains:

. CT: Serovars A, B, Ba, C, F, G, H, I, J, K, L1, L2, L3, and E nvCT at 17.0 EB/mL or less. All serovars were detected at ≥95.0% across swab and urine matrices.
. NG: 28 additional isolates at 7.5 CFU/mL. All isolates were detected at ≥95.0% across swab, urine, and PreservCyt matrices.
. TV: Strains Z070, Z158, and Z159 at 0.1 TV/mL. All strains were detected at ≥ 95.0% across swab, urine, and PreservCyt matrices.
MG: Strains MEGA 601, 10008, MEGA 1256, MEGA 1272, MEGA 1404 and . SEA-2 at 165 GE/mL. All strains were detected at ≥ 95.0% across swab and urine matrices.

5.7.1.3 Evaluation of Potential Cross Reacting Microorganisms

Urogenital Specimens

A total of 71 potential cross reacting microorganisms that are phylogenetically related to CT, NG, TV, or MG or that may be found in the urogenital tract were evaluated with the Alinity m STI Assay (Table 2). The microorganisms were tested at 105 units/mL for

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viruses and eukaryotes and 106 units/mL for bacteria. The unit of measure was specific to each microorganism. No cross reactivity was observed for CT, NG, TV, or MG in the presence of these microorganisms.

A subset of the microorganisms closely related to the STI analytes (asterisk in Table 2) was also assessed in CT, NG, TV, and MG positive samples. The positive samples contained CT, NG, TV, and MG organisms at 2 times the claimed LoD. The potential cross reacting microorganisms were tested at 105 units/mL for viruses and eukaryotes, and 106 units/mL for bacteria. All positive samples reported positive results for CT, NG, TV, and MG in the presence of these microorganisms.

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Table 2. Urogenital Microorganisms

Acinetobacter lwoffi
Actinomyces israelii
Atopobium vaginae
Bacteroides fragilis
Bacteroides ureolyticus (Campylobacter
ureolyticus)
Bifidobacterium longum
Candida albicans
Candida glabrata
Candida parapsilosis
Candida tropicalis
Chlamydia pneumoniae*
Chlamydia psittaci*
Clostridium difficile
Clostridium perfringens
Corynebacterium genitalium
Corynebacterium xerosis
Cryptococcus neoformans
Dientamoeba fragilisa
Enterococcus faecalis
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Fusobacterium nucleatum
Gardnerella vaginalis
Haemophilus ducreyia
Herpes simplex virus I
Herpes simplex virus II
Human Immunodeficiency virus I
Human papilloma virus 16
Kingella denitrificans
Klebsiella oxytoca
Klebsiella pneumoniae
Lactobacillus acidophilus
Lactobacillus brevis
Lactobacillus jensenii
Lactobacillus lactis

Lactobacillus vaginalis Listeria moncytogenes Mobiluncus curtisii Mobiluncus mulieris Mycoplasma hominis* Mycoplasma pneumoniae Neisseria cinerea* Neisseria elongata* Neisseria flava* Neisseria flavescens* Neisseria lactamica* Neisseria mucosa* Neisseria meningitidis Serogroup A * Neisseria meningitidis Serogroup B* Neisseria meningitidis Serogroup C* Neisseria meningitidis Serogroup D* Neisseria meningitidis Serogroup W135 * Neisseria meningitidis Serogroup Y* Neisseria perflava* Neisseria polysaccharea* Neisseria sicca* Neisseria subflava* Pentatrichomonas hominis Peptostreptococcus anaerobius Prevotella bivia Propionibacterium acnes Proteus mirabilis Pseudomonas aeruginosa Staphylococcus aureus Staphylococcus epidermidis Streptococcus agalactiae Streptococcus pyogenes Tricomonas tenax Ureaplasma parvum Ureaplasma urealyticum

ªEvaluated using purified genomic DNA

Note: Microorganisms with asterisks were tested with both CT/NG/TV/MG negative and positive samples. Microorganisms without asterisks were tested with only CT/NG/TV/MG negative samples.

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Extragenital Specimens

A total of 56 additional potential cross reacting microorganisms that may be found in oropharyngeal or rectal specimens were evaluated with the Alinity m STI Assay (Table 3). The microorganisms were tested at 105 units/mL for viruses and eukaryotes and 106 units/mL for bacteria. No cross reactivity was observed for CT or NG in the presence of these microorganisms.

A subset of the microorganisms (asterisk in Table 3) was also assessed in CT and NG positive samples. The positive samples contained CT and NG organisms at 2 times the claimed LoD. The potential cross reacting microorganisms were tested at 105 units/mL for viruses and eukaryotes, and 106 units/mL for bacteria. All positive samples reported positive results for CT and NG in the presence of these microorganisms.

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Table 3. Extragenital Microorganisms

Adenovirus*	Moraxella catarrhalis
Acinetobacter baumannii	Morganella morganii
Aggregatibacter actinomycetemcomitans	Mycoplasma pneumoniae
Anaerococcus prevotii	Norovirus
Arcanobacterium haemolyticum	Parvinomas micra
Bifidobacterium adolescentis	Plesiomonas shigelloides
Bordetella pertussis	Porphyromonas gingivalis
Campylobacter jejuni*	Prevotella oralis
Campylobacter rectus	Providencia stuartii
Citrobacter freundii	Respiratory syncytial virus
Clostridium difficile	Saccharomyces cerevisiae
Corynebacterium diphtheriae*	Salmonella enterica
Entamoeba histolytica*	Shigella flexneri
Enterobacter cloacae	Shigella sonnei
Enterococcus faecium	Streptococcus anginosus
Enterovirus	Streptococcus dysgalactiae*
Fusobacterium necrophorum	Streptococcus mitis
Fusobacterium nucleatum	Streptococcus mutans
Giardia lamblia	Streptococcus pneumoniae
Haemophilus influenzae	Streptococcus pyogenes*
Helicobacter pylori	Streptococcus salivarius
Human Coronavirus*	Streptococcus sanguinis
Human influenza virus A	Tannerella forsythia
Human influenza virus B	Treponema denticola
Human metapneumovirus	Veillonella parvula
Human rhinovirus 57*	Vibrio cholerae
Klebsiella oxytoca	Vibrio parahaemolyticus
Listeria monocytogenes	Yersinia enterocolitica

Note: Microorganisms with asterisks were tested with both CT/NG negative and positive samples. Microorganisms without asterisks were tested with only CT/NG negative samples.

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5.7.1.4 Evaluation of Potential Interfering Substances

Urogenital Specimens

The potential for interference in the Alinity m STI Assay was assessed with 35 substances that may be found in urine, vaginal swab, endocervical swab, and/or PreservCyt samples (Table 4). Substances were diluted into pooled vaginal swab, pooled gynecological PreservCyt, and/or pooled urine matrices. For each substance and matrix, both CT, NG, TV, and MG positive and negative samples were tested. The positive matrices contained CT, NG, TV, and MG organisms at 3 times the claimed assay LoD. Two different strains of each organism were used in this study (CT serovars D and E, NG strains Z433 and Z437, TV strains 30001 and MTZ, and MG strains SEA-1 and MEGA 216). No interference was observed in the presence of any of the substances at the concentrations shown in Table 4 for all positive and negative samples. Assay interference was observed in the presence of seminal fluid at concentrations greater than 3.0% in PreservCyt samples. Cycle number delays were observed for seminal fluid. yglobulin, and glucose in urine and seminal fluid. mucus, and Preparation H Hemorrhoidal Cream in PreservCyt, which could result in interference at lower target levels.

Table 4. Potentially Interfering Substances in Urogenital Specimens
Substance	Matrixa	Test Level
Blood	U, S, P	5.0% v/v
Norforms Deodorant Suppositories	U, S, P	0.25% w/v
Progesterone	U, S, P	20 ng/mL
Beta Estradiol	U, S, P	1.2 ng/mL
Leukocytes	U, S, P	106 cells/mL
Mucus	U	0.2% v/v
	S, Pb	0.8% v/v
Seminal Fluid	Ub, S	5.0% v/v
	Pb	3.0% v/v
Azithromycin	U	12.0 µg/mL
Doxycycline	U	31.2 µg/mL
Acetaminophen	U	196.5 µg/mL
Aspirin	U	652.2 µg/mL
Vagisil Feminine Powder	U	0.25% w/v

Table 4 Potentially Interfering Substances in Urogenital Speciments

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Substance	Matrixa	Test Level
Albumin	U	60 mg/mL
γ-globulin	Ub	60 mg/mL
Glucose	Ub	1.2 mg/mL
Acidic urine	U	pH 4.0
Alkaline urine	U	pH 9.0
Bilirubin	U	72.5 µg/mL
Candida albicans
(Urinary tract infection organism)	U	3x104 CFU/mL
Staphylococcus saprophyticus
(Urinary tract infection organism)	U	3x104 CFU/mL
Escherichia coli
(Urinary tract infection organism)	U	3x104 CFU/mL
Ibuprofen	U	495.1 µg/mL
Phenazopyridine Hydrochloride	U	80 µg/mL
Clotrimazole Vaginal Cream	S, P	0.25% w/v
KY Jelly Personal Lubricant	S, P	0.25% w/v
Metronidazole	S, P	40.1 µg/mL
Miconazole-3	S, P	0.25% w/v
Monistat-1	S, P	0.25% w/v
Terconazole Vaginal Cream	S, P	0.25% w/v
Preparation H Hemorroidal Cream	S, Pb	0.25% w/v
Vagisil Anti-Itch Cream	S, P	0.25% w/v
Vagisil Moisturizing Gel	S, P	0.25% w/v
Povidone-Iodine Medicated Douche	S, P	0.25% w/v
Yeast Gard Douche	S, P	0.25% w/v
Vaginal Contraceptive Foam	S, P	0.25% w/v

Table 4. Potentially Interfering Substances in Urogenital Specimens

a U=Urine, S = Swab, P = PreservCyt

bCycle number delays were observed for seminal fluid, y-globulin, and glucose in urine and seminal fluid, mucus, and Preparation H Hemorrhoidal Cream in PreservCyt, which could result in interference at lower target levels.

23

Extragenital Specimens

The potential for interference in the Alinity m STI Assay was assessed with 18 substances that may be found in oropharyngeal or rectal swab samples (Table 5). Substances were diluted into pooled oropharyngeal swab or pooled rectal swab matrices. For each substance and matrix, both CT and NG positive and negative samples were tested. The positive matrices contained CT and NG at 3 times the claimed LoD. Two different strains of CT and NG were used in this study (CT serovars D and E and NG strains Z433 and Z437). No interference was observed in the presence of the substances at the concentrations shown in Table 5 for all positive and negative samples. Cycle number delays were observed for Sensodyne Repair & Protect Sensitive Toothpaste in oropharyngeal specimens and feces in rectal specimens, which could result in interference at lower target levels.

Substance	Matrixᵃ	Test Level
Blood	O	5.0% v/v
Mucus	O	25 mg/mL
Listerine Antiseptic Mouthwash	O	5.0% v/v
Mucinex Dextromethorphan Cough Suppressant	O	100 ug/mL
Chloraseptic Sore Throat Spray, Menthol	O	5.0% v/v
Abreva Cold Sore Medication	O	5.0% w/v
Colgate Total Whitening Toothpaste	O	0.25% w/v
Arm & Hammer PeroxiCare Deep Clean Toothpaste	O	0.25% w/v
Sensodyne Repair & Protect Sensitive Toothpaste	Oᵇ	0.25% w/v
Preparation H Hemorrhoidal Cream	R	0.25% w/v
Barium Sulfate	R	0.25% w/v
Dulcolax Laxative Suppository	R	0.25% w/v
K-Y Jelly Personal Lubricant	R	0.25% w/v
Phillips' Milk of Magnesia Liquid Laxative	R	0.25% w/v
Pepto-Bismol	R	0.25% w/v
Imodium	R	0.25% w/v
Feces	Rᵇ	1.0% w/v
Lotrimin	R	0.25% w/v

Table 5. Potentially Interfering Substances in Oropharyngeal or Rectal Specimens

ª O = Oropharyngeal, R = Rectal

b Cycle number delays were observed for Sensodyne Repair & Protect Sensitive Toothpaste in

24

oropharyngeal specimens and feces in rectal specimens, which could result in interference at lower target levels.

Competitive Interference Study 5.7.1.5

A competitive interference study was conducted to challenge the performance of the Alinity m STI Assay with swab, PreservCyt, and urine samples containing CT, NG, TV, or MG at 3 times the claimed LoD in the presence of high concentrations of the other three organisms. The high positive targets were prepared with titers of 3.0x10 EB/mL for CT, 1.6x104 CFU/mL for NG, 6.0x104 TV/mL for TV, and 1.1x106 GE/mL for MG. Four conditions were evaluated:

CT at 3 times the claimed LoD and NG, TV, and MG at high concentrations .
NG at 3 times the claimed LoD and CT, TV, and MG at high concentrations .
TV at 3 times the claimed LoD and CT, NG, and MG at high concentrations .
. MG at 3 times the claimed LoD and CT, NG, and TV at high concentrations

For each analyte at the low concentration, 100% (20/20) of replicates were detected in each matrix.

Within Laboratory Precision 5.7.1.6

Alinity m STI Assay within laboratory precision was evaluated by testing panel members in 3 different sample matrices that represent urogenital specimen types used in the Alinity m STI Assay: urine, swab, and PreservCyt matrix. For each applicable specimen matrix, 13 panel members were prepared with combinations of CT, NG, TV, and MG at sub-LoD (high negative), claimed LoD, low positive (2x claimed LoD), high positive, and negative target levels (Table 6). Each panel member was tested in 2 replicates, twice each day for 12 days, on 3 Alinity m Systems with 3 reagent lots by 3 operators, for a total of 144 replicates. The results for CT, NG, TV, and MG are summarized in Table 7, Table 8, Table 9, and Table 10 respectively.

25

| Panel

Member	CT	NG	TV	MG
1	Negative	Negative	Negative	Negative
2	2X LoD Claim	Negative	Negative	Negative
3	Negative	2X LoD Claim	Negative	Negative
4	Negative	Negative	2X LoD Claim	Negative
5	Negative	Negative	Negative	2X LoD Claim
6	2X LoD Claim	2X LoD Claim	2X LoD Claim	2X LoD Claim
7	High Positivea	2X LoD Claim	2X LoD Claim	2X LoD Claim
8	2X LoD Claim	High Positiveb	2X LoD Claim	2X LoD Claim
9	2X LoD Claim	2X LoD Claim	High Positivec	2X LoD Claim
10	2X LoD Claim	2X LoD Claim	2X LoD Claim	High Positived
11	High Positivea	High Positiveb	High Positivec	High Positived
12	LoD Claim	LoD Claim	LoD Claim	LoD Claim
13	Sub-LoD
(High Negative)	Sub-LoD
(High Negative)	Sub-LoD
(High Negative)	Sub-LoD
(High Negative)

Table 6. Precision Panel Composition

ªConcentration for High CT is 4.4 X 104 IFU/mL or 8.8 X 103 IFU/assay (3.0x105 EB/mL or 6.0x10* EB/assay) bConcentration for High NG is 1.6 X 104 CFU/mL or 3.2 X 103 CFU/assay

℃oncentration for High TV is 6.0 X 104 TV/mL or 1.2 X 104 TV/assay

4Concentration for High MG is 1.1 X 106 genome copies/mL or 2.2 X 105 genome copies/assay

26

Table 7. Within Lab Precision: CT Results

| | | | | | | Within-Run
Component | | Between-Run
Component | | Between-Day
Component | | Within-
Laboratory | | Between-
Instrument/Lot
Component | | Totald | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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| Matrix | Panel Description | Na | nb | Agreement
(n/N) | Mean
CN | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Urine | CT High Pos
(NG, TV & MG High Pos) | 144 | 144 | 100.0% | 16.62 | 0.191 | 1.2 | 0.133 | 0.8 | 0.133 | 0.8 | 0.655 | 3.9 | 0.094 | 0.6 | 0.662 | 4.0 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT High Pos
(NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 17.03 | 0.162 | 1.0 | 0.138 | 0.8 | 0.138 | 0.8 | 0.457 | 2.7 | 0.229 | 1.3 | 0.511 | 3.0 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at 2X LOD Claim
(TV High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.18 | 0.246 | 0.8 | 0.121 | 0.4 | 0.121 | 0.4 | 0.613 | 2.0 | 0.160 | 0.5 | 0.634 | 2.1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at 2X LOD Claim
(NG High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.65 | 0.171 | 0.6 | 0.125 | 0.4 | 0.125 | 0.4 | 0.352 | 1.1 | 0.232 | 0.8 | 0.422 | 1.4 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at 2 X LOD Claim
(MG High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.37 | 0.213 | 0.7 | 0.069 | 0.2 | 0.069 | 0.2 | 0.311 | 1.0 | 0.231 | 0.8 | 0.388 | 1.3 | CT at 2X LOD Claim
(NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.80 | 0.380 | 1.2 | 0.079 | 0.3 | 0.079 | 0.3 | 0.489 | 1.6 | 0.321 | 1.0 | 0.585 | 1.9 | CT at 2X LOD Claim
(CT only) | 144 | 144 | 100.0% | 30.23 | 0.180 | 0.6 | 0.165 | 0.5 | 0.165 | 0.5 | 0.287 | 0.9 | 0.177 | 0.6 | 0.337 | 1.1 | CT at LOD Claim | 144 | 144 | 100.0% | 31.73 | 0.164 | 0.5 | 0.112 | 0.4 | 0.112 | 0.4 | 0.404 | 1.3 | 0.204 | 0.6 | 0.453 | 1.4 | | CT at Sub-LOD
(High Negative) | 144 | 76 | 52.8% | 37.08 | 0.522 | 1.4 | 0.101 | 0.3 | 0.101 | 0.3 | 0.630 | 1.7 | 0.240 | 0.6 | 0.675 | 1.8 | CT Negativee | 576 | 575 | 99.8% | | | | | | | | | | | | | | Swab | CT High Pos
(NG, TV & MG High Pos) | 144 | 144 | 100.0% | 16.94 | 0.219 | 1.3 | 1.645 | 9.7 | 1.645 | 9.7 | 1.659 | 9.8 | 0.253 | 1.5 | 1.679f | 9.9 | CT High Pos
(NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 16.97 | 0.083 | 0.5 | 0.046 | 0.3 | 0.046 | 0.3 | 0.103 | 0.6 | 0.109 | 0.6 | 0.150 | 0.9 | CT at 2X LOD Claim
(TV High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.58 | 0.102 | 0.3 | 0.000 | 0.0 | 0.000 | 0.0 | 0.116 | 0.4 | 0.113 | 0.4 | 0.162 | 0.5 | CT at 2X LOD Claim
(NG High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.53 | 0.102 | 0.3 | 0.037 | 0.1 | 0.037 | 0.1 | 0.125 | 0.4 | 0.140 | 0.5 | 0.188 | 0.6 | | CT at 2 X LOD Claim
(MG High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 29.62 | 0.113 | 0.4 | 0.027 | 0.1 | 0.027 | 0.1 | 0.119 | 0.4 | 0.137 | 0.5 | 0.181 | 0.6 | CT at 2X LOD Claim
(NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.60 | 0.163 | 0.5 | 0.071 | 0.2 | 0.071 | 0.2 | 0.183 | 0.6 | 0.170 | 0.6 | 0.249 | 0.8 | CT at 2X LOD Claim
(CT only) | 144 | 144 | 100.0% | 29.71 | 0.084 | 0.3 | 0.022 | 0.1 | 0.022 | 0.1 | 0.090 | 0.3 | 0.105 | 0.4 | 0.138 | 0.5 | CT at LOD Claim | 144 | 144 | 100.0% | 30.51 | 0.230 | 0.8 | 0.036 | 0.1 | 0.036 | 0.1 | 0.236 | 0.8 | 0.117 | 0.4 | 0.264 | 0.9 | CT at Sub-LOD
(High Negative) | 144 | 88 | 61.1% | 36.60 | 0.543 | 1.5 | 0.193 | 0.5 | 0.193 | 0.5 | 0.576 | 1.6 | 0.298 | 0.8 | 0.649 | 1.8 | CT Negativee | 576 | 575 | 99.8% | | | | | | | | | | | | | |
| | | CT at 2 X LOD Claim
(MG High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.37 | 0.213 | 0.7 | 0.069 | 0.2 | 0.069 | 0.2 | 0.311 | 1.0 | 0.231 | 0.8 | 0.388 | 1.3 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | CT at 2X LOD Claim
(NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.80 | 0.380 | 1.2 | 0.079 | 0.3 | 0.079 | 0.3 | 0.489 | 1.6 | 0.321 | 1.0 | 0.585 | 1.9 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | CT at 2X LOD Claim
(CT only) | 144 | 144 | 100.0% | 30.23 | 0.180 | 0.6 | 0.165 | 0.5 | 0.165 | 0.5 | 0.287 | 0.9 | 0.177 | 0.6 | 0.337 | 1.1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| CT at LOD Claim | | 144 | 144 | 100.0% | 31.73 | 0.164 | 0.5 | 0.112 | 0.4 | 0.112 | 0.4 | 0.404 | 1.3 | 0.204 | 0.6 | 0.453 | 1.4 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at Sub-LOD
(High Negative) | 144 | 76 | 52.8% | 37.08 | 0.522 | 1.4 | 0.101 | 0.3 | 0.101 | 0.3 | 0.630 | 1.7 | 0.240 | 0.6 | 0.675 | 1.8 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT Negativee | 576 | 575 | 99.8% | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Swab | CT High Pos
(NG, TV & MG High Pos) | 144 | 144 | 100.0% | 16.94 | 0.219 | 1.3 | 1.645 | 9.7 | 1.645 | 9.7 | 1.659 | 9.8 | 0.253 | 1.5 | 1.679f | 9.9 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | CT High Pos
(NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 16.97 | 0.083 | 0.5 | 0.046 | 0.3 | 0.046 | 0.3 | 0.103 | 0.6 | 0.109 | 0.6 | 0.150 | 0.9 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| CT at 2X LOD Claim
(TV High Pos, NG & MG at 2X LOD Claim) | | 144 | 144 | 100.0% | 29.58 | 0.102 | 0.3 | 0.000 | 0.0 | 0.000 | 0.0 | 0.116 | 0.4 | 0.113 | 0.4 | 0.162 | 0.5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| CT at 2X LOD Claim
(NG High Pos, TV & MG at 2X LOD Claim) | | 144 | 144 | 100.0% | 29.53 | 0.102 | 0.3 | 0.037 | 0.1 | 0.037 | 0.1 | 0.125 | 0.4 | 0.140 | 0.5 | 0.188 | 0.6 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | CT at 2 X LOD Claim
(MG High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 29.62 | 0.113 | 0.4 | 0.027 | 0.1 | 0.027 | 0.1 | 0.119 | 0.4 | 0.137 | 0.5 | 0.181 | 0.6 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at 2X LOD Claim
(NG, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.60 | 0.163 | 0.5 | 0.071 | 0.2 | 0.071 | 0.2 | 0.183 | 0.6 | 0.170 | 0.6 | 0.249 | 0.8 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at 2X LOD Claim
(CT only) | 144 | 144 | 100.0% | 29.71 | 0.084 | 0.3 | 0.022 | 0.1 | 0.022 | 0.1 | 0.090 | 0.3 | 0.105 | 0.4 | 0.138 | 0.5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at LOD Claim | 144 | 144 | 100.0% | 30.51 | 0.230 | 0.8 | 0.036 | 0.1 | 0.036 | 0.1 | 0.236 | 0.8 | 0.117 | 0.4 | 0.264 | 0.9 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | CT at Sub-LOD
(High Negative) | 144 | 88 | 61.1% | 36.60 | 0.543 | 1.5 | 0.193 | 0.5 | 0.193 | 0.5 | 0.576 | 1.6 | 0.298 | 0.8 | 0.649 | 1.8 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| CT Negativee | 576 | 575 | 99.8% | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

a N:Total number of replicates

bn: Number of replicates with deectable parel and non-dected for negative parel; the number of replicates vere used for the Mean and SD calculation.

C Within-Laboratory includes Within-Run, Between-Run and Between-Day Components.

d Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components.

€ The negative panel included 4 panel members negative for CT

Tw samles ladedlular contr (CC) filines and very has a minim in ST assy reports prairie cestle centrif the Child the tod SD and W. Whot those samples, the total SD was 0.143 and the total % CV was 0.9.

27

Table 8. Within Lab Precision: NG Results

| | | | | | | Within-Run
Component | | Between-Run
Component | | Between-Day
Component | | Within-
Laboratory | | Between-
Instrument/Lot
Component | | Totalª | |
|------------|---------------------------------------------------------------------------|-----|------|--------------------|------------|-------------------------|------|--------------------------|------|--------------------------|------|------------------------|------|-----------------------------------------|------|--------|----------|
| Matrix | Panel Description | Nª | Nb | Agreement
(n/N) | Mean
CN | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| | NG High Pos (CT, TV & MG High Pos) | 144 | 144 | 100.0% | 21.89 | 0.183 | 0.8 | 0.138 | 0.6 | 0.138 | 0.6 | 0.322 | 1.5 | 0.209 | 1.0 | 0.384 | 1.8 |
| | NG High Pos
(CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 22.41 | 0.230 | 1.0 | 0.206 | 0.9 | 0.206 | 0.9 | 0.416 | 1.9 | 0.193 | 0.9 | 0.458 | 2.0 |
| | NG at 2X LOD Claim
(MG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.95 | 0.287 | 0.9 | 0.044 | 0.1 | 0.044 | 0.1 | 0.391 | 1.3 | 0.140 | 0.5 | 0.415 | 1.3 |
| | NG at 2X LOD Claim
(TV High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.72 | 0.245 | 0.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.318 | 1.0 | 0.197 | 0.6 | 0.374 | 1.2 |
| Urine | NG at 2X LOD Claim
(CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.37 | 0.291 | 0.9 | 0.207 | 0.7 | 0.207 | 0.7 | 0.433 | 1.4 | 0.022 | 0.1 | 0.434 | 1.4 |
| | NG at 2X LOD Claim
(CT High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.24 | 0.212 | 0.7 | 0.144 | 0.5 | 0.144 | 0.5 | 0.346 | 1.1 | 0.093 | 0.3 | 0.359 | 1.1 |
| | NG at 2X LOD Claim (NG only) | 144 | 144 | 100.0% | 31.23 | 0.189 | 0.6 | 0.000 | 0.0 | 0.000 | 0.0 | 0.241 | 0.8 | 0.083 | 0.3 | 0.255 | 0.8 |
| | NG at LOD Claim | 144 | 144 | 100.0% | 32.32 | 0.217 | 0.7 | 0.149 | 0.5 | 0.149 | 0.5 | 0.384 | 1.2 | 0.126 | 0.4 | 0.404 | 1.3 |
| | NG at Sub-LOD
(High Negative) | 144 | 119 | 82.6% | 37.80 | 0.849 | 2.2 | 0.191 | 0.5 | 0.191 | 0.5 | 0.870 | 2.3 | 0.527 | 1.4 | 1.017 | 2.7 |
| | NG Negative | 576 | 576 | 100.0% | | | | | | | | | | | | | |
| | NG High Pos (CT, TV & MG High Pos) | 144 | 144 | 100.0% | 21.31 | 0.135 | 0.6 | 0.117 | 0.6 | 0.117 | 0.6 | 0.194 | 0.9 | 0.232 | 1.1 | 0.303 | 1.4 |
| | NG High Pos
(CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 22.07 | 0.165 | 0.7 | 0.184 | 0.8 | 0.184 | 0.8 | 0.342 | 1.5 | 0.134 | 0.6 | 0.367 | 1.7 |
| | NG at 2X LOD Claim
(MG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.45 | 0.179 | 0.6 | 0.092 | 0.3 | 0.092 | 0.3 | 0.238 | 0.8 | 0.126 | 0.4 | 0.270 | 0.9 |
| | NG at 2X LOD Claim
(TV High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.32 | 0.159 | 0.5 | 0.166 | 0.5 | 0.166 | 0.5 | 0.289 | 0.9 | 0.136 | 0.4 | 0.319 | 1.0 |
| Swab | NG at 2X LOD Claim
(CT, TV & MG at 2X LOD Claim)
NG at 2X LOD Claim | 144 | 144 | 100.0% | 31.40 | 0.173 | 0.5 | 0.258 | 0.8 | 0.258 | 0.8 | 0.323 | 1.0 | 0.000 | 0.0 | 0.323 | 1.0 |
| | (CT High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.33 | 0.192 | 0.6 | 0.119 | 0.4 | 0.119 | 0.4 | 0.276 | 0.9 | 0.171 | 0.5 | 0.324 | 1.0 |
| | NG at 2X LOD Claim (NG only) | 144 | 144 | 100.0% | 31.49 | 0.173 | 0.6 | 0.096 | 0.3 | 0.096 | 0.3 | 0.205 | 0.6 | 0.196 | 0.6 | 0.283 | 0.9 |
| | NG at LOD Claim | 144 | 144 | 100.0% | 32.16 | 0.201 | 0.6 | 0.103 | 0.3 | 0.103 | 0.3 | 0.243 | 0.8 | 0.127 | 0.4 | 0.274 | 0.9 |
| | NG at Sub-LOD
(High Negative) | 144 | 122 | 84.7% | 36.76 | 0.730 | 2.0 | 0.198 | 0.5 | 0.198 | 0.5 | 0.757 | 2.1 | 0.266 | 0.7 | 0.802 | 2.2 |
| | NG Negative® | 576 | 576 | 100.0% | | | | | | | | | | | | | |
| | NG High Pos (CT, TV & MG High Pos) | 144 | 144 | 100.0% | 21.28 | 0.147 | 0.7 | 0.177 | 0.8 | 0.177 | 0.8 | 0.230 | 1.1 | 0.162 | 0.8 | 0.281 | 1.3 |
| | NG High Pos
(CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 24.04 | 0.191 | 0.8 | 0.063 | 0.3 | 0.063 | 0.3 | 0.205 | 0.9 | 0.232 | 1.0 | 0.310 | 1.3 |
| | NG at 2X LOD Claim
(MG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.66 | 0.181 | 0.6 | 0.082 | 0.3 | 0.082 | 0.3 | 0.199 | 0.6 | 0.129 | 0.4 | 0.237 | 0.8 |
| | NG at 2X LOD Claim
(TV High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.91 | 0.164 | 0.5 | 0.086 | 0.3 | 0.086 | 0.3 | 0.198 | 0.6 | 0.220 | 0.7 | 0.296 | 1.0 |
| PreservCyt | NG at 2X LOD Claim
(CT, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.80 | 0.253 | 0.8 | 0.081 | 0.3 | 0.081 | 0.3 | 0.278 | 0.9 | 0.134 | 0.4 | 0.309 | 1.0 |
| | NG at 2X LOD Claim
(CT High Pos, TV & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.35 | 0.219 | 0.7 | 0.103 | 0.3 | 0.103 | 0.3 | 0.242 | 0.8 | 0.195 | 0.6 | 0.311 | 1.0 |
| | NG at 2X LOD Claim (NG only) | 144 | 144 | 100.0% | 31.18 | 0.224 | 0.7 | 0.109 | 0.4 | 0.109 | 0.4 | 0.266 | 0.9 | 0.250 | 0.8 | 0.365 | 1.2 |
| | NG at LOD Claim | 144 | 144 | 100.0% | 32.87 | 0.272 | 0.8 | 0.185 | 0.6 | 0.185 | 0.6 | 0.329 | 1.0 | 0.153 | 0.5 | 0.363 | 1.1 |
| | NG at Sub-LOD
(High Negative) | 144 | ર્ ર | 45.1% | 37.31 | 0.613 | 1.6 | 0.332 | 0.9 | 0.332 | 0.9 | 0.698 | 1.9 | 0.232 | 0.6 | 0.735 | 2.0 |
| | NG Negative® | 576 | 576 | 100.0% | | | | | | …… | : | | | …… | | | |
| | Panel Description | | Nb | | | Within-Run
Component | | Between-Run
Component | | Between-Day
Component | | Within-
Laboratory | | Between-
Instrument/Lot
Component | | Totalª | |
| Matrix | | Nª | | Agreement
(n/N) | Mean
CN | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % C
V |
| | TV High Pos
(CT, NG & MG High Pos) | 144 | 144 | 100.0% | 9.85 | 0.274 | 2.8 | 0.178 | 1.8 | 0.178 | 1.8 | 0.706 | 7.2 | 0.256 | 2.6 | 0.751 | 7.6 |
| | TV High Pos
(CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 9.85 | 0.353 | 3.6 | 0.204 | 2.1 | 0.204 | 2.1 | 0.758 | 7.7 | 0.357 | 3.6 | 0.837 | 8.5 |
| | TV at 2X LOD Claim
(MG High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.30 | 0.245 | 0.9 | 0.101 | 0.4 | 0.101 | 0.4 | 0.360 | 1.3 | 0.295 | 1.1 | 0.465 | 1.7 |
| | TV at 2X LOD Claim
(NG High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.60 | 0.186 | 0.7 | 0.175 | 0.6 | 0.175 | 0.6 | 0.397 | 1.4 | 0.353 | 1.3 | 0.531 | 1.9 |
| Urine | TV at 2X LOD Claim
(CT High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.58 | 0.224 | 0.8 | 0.061 | 0.2 | 0.061 | 0.2 | 0.461 | 1.7 | 0.297 | 1.1 | 0.548 | 2.0 |
| | TV at 2X LOD Claim
(CT, NG & MG at 2X LOD Claim) | 144 | 143 | 99.3% | 27.84 | 0.210 | 0.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.368 | 1.3 | 0.341 | 1.2 | 0.502 | 1.8 |
| | TV at 2X LOD Claim
(TV only) | 144 | 144 | 100.0% | 27.22 | 0.266 | 1.0 | 0.000 | 0.0 | 0.000 | 0.0 | 0.393 | 1.4 | 0.375 | 1.4 | 0.543 | 2.0 |
| | TV at LOD Claim | 144 | 144 | 100.0% | 28.73 | 0.355 | 1.2 | 0.190 | 0.7 | 0.190 | 0.7 | 0.520 | 1.8 | 0.321 | 1.1 | 0.611 | 2.1 |
| | TV at Sub-LOD
(High Negative) | 144 | 34 | 23.6% | 33.89 | 0.956 | 2.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.978 | 2.9 | 0.355 | 1.0 | 1.041 | 3.1 |
| | TV Negative® | 576 | 574 | 99.7% | | | | | | | | | | | | | |
| | TV High Pos
(CT, NG & MG High Pos) | 144 | 144 | 100.0% | 10.44 | 0.267 | 2.6 | 1.679 | 16.1 | 1.679 | 16.1 | 1.704 | 16.3 | 0.583 | 5.6 | 1.801 | 17.3 |
| | TV High Pos
(CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 10.13 | 0.170 | 1.7 | 0.025 | 0.2 | 0.025 | 0.2 | 0.221 | 2.2 | 0.371 | 3.7 | 0.432 | 4.3 |
| | TV at 2X LOD Claim
(MG High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.31 | 0.376 | 1.3 | 0.159 | 0.5 | 0.159 | 0.5 | 0.409 | 1.4 | 0.295 | 1.0 | 0.504 | 1.7 |
| | TV at 2X LOD Claim
(NG High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.11 | 0.192 | 0.7 | 0.093 | 0.3 | 0.093 | 0.3 | 0.265 | 0.9 | 0.330 | 1.1 | 0.423 | 1.5 |
| Swab | TV at 2X LOD Claim
(CT High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 29.24 | 0.200 | 0.7 | 0.161 | 0.6 | 0.161 | 0.6 | 0.280 | 1.0 | 0.298 | 1.0 | 0.409 | 1.4 |
| | TV at 2X LOD Claim
(CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 28.94 | 0.338 | 1.2 | 0.165 | 0.6 | 0.165 | 0.6 | 0.402 | 1.4 | 0.275 | 0.9 | 0.487 | 1.7 |
| | TV at 2X LOD Claim
(TV only) | 144 | 144 | 100.0% | 26.99 | 0.190 | 0.7 | 0.054 | 0.2 | 0.054 | 0.2 | 0.207 | 0.8 | 0.264 | 1.0 | 0.336 | 1.2 |
| | TV at LOD Claim | 144 | 144 | 100.0% | 29.75 | 0.334 | 1.1 | 0.055 | 0.2 | 0.055 | 0.2 | 0.352 | 1.2 | 0.259 | 0.9 | 0.437 | 1.5 |
| | TV at Sub-LOD
(High Negative) | 144 | 135 | 93.8% | 33.55 | 0.378 | 1.1 | 0.000 | 0.0 | 0.000 | 0.0 | 0.411 | 1.2 | 0.151 | 0.5 | 0.438 | 1.3 |
| | TV Negative® | 576 | 575 | 99.8% | | | | | | | | | | | | | |
| | TV High Pos
(CT, NG & MG High Pos) | 144 | 144 | 100.0% | 9.11 | 0.182 | 2.0 | 0.152 | 1.7 | 0.152 | 1.7 | 0.238 | 2.6 | 0.394 | 4.3 | 0.460 | 5.1 |
| | TV High Pos
(CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 8.54 | 0.166 | 1.9 | 0.099 | 1.2 | 0.099 | 1.2 | 0.193 | 2.3 | 0.356 | 4.2 | 0.405 | 4.7 |
| | TV at 2X LOD Claim
(MG High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 26.98 | 0.291 | 1.1 | 0.126 | 0.5 | 0.126 | 0.5 | 0.317 | 1.2 | 0.368 | 1.4 | 0.486 | 1.8 |
| | TV at 2X LOD Claim
(NG High Pos, CT & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 27.41 | 0.216 | 0.8 | 0.206 | 0.8 | 0.206 | 0.8 | 0.304 | 1.1 | 0.376 | 1.4 | 0.483 | 1.8 |
| PreservCyt | TV at 2X LOD Claim
(CT High Pos, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 26.59 | 0.166 | ().6 | 0.063 | 0.2 | 0.063 | 0.2 | 0.180 | 0.7 | 0.315 | 1.2 | 0.363 | 1.4 |
| | TV at 2X LOD Claim
(CT, NG & MG at 2X LOD Claim) | 144 | 144 | 100.0% | 28.11 | 0.289 | 1.0 | 0.124 | 0.4 | 0.124 | 0.4 | 0.314 | 1.1 | 0.248 | 0.9 | 0.401 | 1.4 |
| | TV at 2X LOD Claim
(TV only) | 144 | 144 | 100.0% | 27.88 | 0.128 | 0.5 | 0.101 | 0.4 | 0.101 | 0.4 | 0.201 | 0.7 | 0.331 | 1.2 | 0.388 | 1.4 |
| | TV at LOD Claim | 144 | 144 | 100.0% | 29.01 | 0.452 | 1.6 | 0.000 | 0.0 | 0.000 | 0.0 | 0.466 | 1.6 | 0.247 | 0.9 | 0.527 | 1.8 |
| | TV at Sub-LOD
(High Negative) | 144 | 85 | 59.0% | 33.95 | 0.352 | 1.0 | 0.000 | 0.0 | 0.000 | 0.0 | 0.373 | 1.1 | 0.096 | 0.3 | 0.385 | 1.1 |
| | TV Negative® | 576 | 575 | 99.8% | | | | | | | | | | | | | |
| | Panel Description | | Nᵇ | Agreement
(n/N) | | Within-Run
Component | | Between-Run
Component | | Between-Day
Component | | Within-
Laboratoryᶜ | | Between-
Instrument/Lot
Component | | Totalᵈ | |
| Matrix | | Nᵃ | | | Mean
CN | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| | MG High Pos
(CT, NG & TV High Pos) | 144 | 144 | 100.0% | 20.57 | 0.199 | 1.0 | 0.149 | 0.7 | 0.149 | 0.7 | 0.660 | 3.2 | 0.423 | 2.1 | 0.784 | 3.8 |
| Urine | MG High Pos (CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 21.63 | 0.219 | 1.0 | 0.098 | 0.5 | 0.098 | 0.5 | 0.352 | 1.6 | 0.472 | 2.2 | 0.589 | 2.7 |
| | MG at 2X LOD Claim
(TV High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 31.39 | 0.315 | 1.0 | 0.148 | 0.5 | 0.148 | 0.5 | 0.692 | 2.2 | 0.443 | 1.4 | 0.822 | 2.6 |
| | MG at 2X LOD Claim
(NG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.76 | 0.242 | 0.8 | 0.182 | 0.6 | 0.182 | 0.6 | 0.438 | 1.4 | 0.498 | 1.6 | 0.663 | 2.1 |
| | MG at 2X LOD Claim
(CT High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.74 | 0.242 | 0.8 | 0.112 | 0.4 | 0.112 | 0.4 | 0.517 | 1.6 | 0.440 | 1.4 | 0.679 | 2.1 |
| | MG at 2X LOD Claim
(CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 31.77 | 0.672 | 2.1 | 0.000 | 0.0 | 0.000 | 0.0 | 0.758 | 2.4 | 0.559 | 1.8 | 0.942 | 3.0 |
| | MG at 2X LOD Claim (MG only) | 144 | 144 | 100.0% | 31.73 | 0.139 | 0.4 | 0.087 | 0.3 | 0.087 | 0.3 | 0.305 | 1.0 | 0.376 | 1.2 | 0.484 | 1.5 |
| | MG at LOD Claim | 144 | 144 | 100.0% | 32.90 | 0.317 | 1.0 | 0.126 | 0.4 | 0.126 | 0.4 | 0.589 | 1.8 | 0.530 | 1.6 | 0.792 | 2.4 |
| | MG at Sub-LOD
(High Negative) | 144 | 111 | 77.1% | 38.85 | 1.084 | 2.8 | 0.125 | 0.3 | 0.125 | 0.3 | 1.364 | 3.5 | 0.000 | 0.0 | 1.364 | 3.5 |
| | MG Negativeᵉ | 576 | 576 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| | MG High Pos
(CT, NG & TV High Pos) | 144 | 144 | 100.0% | 19.85 | 0.404 | 2.0 | 1.826 | 9.2 | 1.826 | 9.2 | 1.870 | 9.4 | 0.574 | 2.9 | 1.956 | 9.9ᶠ |
| | MG High Pos (CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 20.58 | 0.141 | 0.7 | 0.081 | 0.4 | 0.081 | 0.4 | 0.163 | 0.8 | 0.382 | 1.9 | 0.415 | 2.0 |
| | MG at 2X LOD Claim
(TV High Pos, CT & NG at 2X LOD Claim) | 144 | 144 | 100.0% | 30.90 | 0.141 | 0.5 | 0.017 | 0.1 | 0.017 | 0.1 | 0.153 | 0.5 | 0.337 | 1.1 | 0.370 | 1.2 |
| | MG at 2X LOD Claim
(NG High Pos, CT & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.76 | 0.158 | 0.5 | 0.038 | 0.1 | 0.038 | 0.1 | 0.182 | 0.6 | 0.324 | 1.1 | 0.371 | 1.2 |
| Swab | MG at 2X LOD Claim
(CT High Pos, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.86 | 0.123 | 0.4 | 0.072 | 0.2 | 0.072 | 0.2 | 0.147 | 0.5 | 0.307 | 1.0 | 0.340 | 1.1 |
| | MG at 2X LOD Claim
(CT, NG & TV at 2X LOD Claim) | 144 | 144 | 100.0% | 30.72 | 0.199 | 0.6 | 0.130 | 0.4 | 0.130 | 0.4 | 0.243 | 0.8 | 0.327 | 1.1 | 0.407 | 1.3 |
| | MG at 2X LOD Claim (MG only) | 144 | 144 | 100.0% | 31.31 | 0.137 | 0.4 | 0.079 | 0.3 | 0.079 | 0.3 | 0.160 | 0.5 | 0.252 | 0.8 | 0.298 | 1.0 |
| | MG at LOD Claim | 144 | 144 | 100.0% | 31.55 | 0.248 | 0.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.248 | 0.8 | 0.270 | 0.9 | 0.367 | 1.2 |
| | MG at Sub-LOD
(High Negative) | 144 | 94 | 65.3% | 35.95 | 0.409 | 1.1 | 0.263 | 0.7 | 0.263 | 0.7 | 0.487 | 1.4 | 0.171 | 0.5 | 0.516 | 1.4 |
| | MG Negativeᵉ | 576 | 576 | 100.0% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |

a N: total number of replicates

b n: Number of replicates with detectable parel and non-detected for negative panel; the number of replicates were used for the Mean and SD calculation.

C Within-Laboratory includes Within-Run, Between-Run and Between-Day Components.

d Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components.

€ The negative panel included 4 panel members negative for NG.

28

Table 9. Within Lab Precision: TV Results

a N: Total number of replicates,

b n: Number of replicates with detectable parel and non-etected for negative parel; the nurber of replicates were used for the Mean and SD calculation.

C Within-Laboratory includes Within-Run, Between-Run and Between-Day Components.

d Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components.

e The negative panel included 4 panel members negative for TV.

"Two same hadellate control (C) filimes and very Let any envire positives and the CCails, the Child Me call Del MCV. West Dan MCV. Web the sappes, per and sole in the sample, was 0.402 and the total %CV was 3.9.

29

Table 10. Within Lab Precision: MG Results

a N: Total number of replicates

b n . Number of replicates with detectable parel and nor-ecected for negative panel, the number of replicates were used for the Mean and SD calculation.

C Within-Laboratory includes Within-Run, Between-Run and Between-Day Components.

d Total includes Within-Run, Between-Run, Between-Day and Between-Instrument/Lot Components

e The negative panel included 4 panel members negative for MG.

" Try samles hadeellar contribute in the argent and the M. Assy contre ends event to C. C. C. in the collection versions were included in the cold S. What unes samps, the onl SD was 0.361 and the total %CV was 1.8.

30

5.7.1.7 Carryover

The carryover rate for Alinity m STI Assay was determined by testing alternating replicates of STI high positive samples and STI negative samples across multiple runs. The high positive samples were prepared with titers greater than or equal to 3.0x105 EB/mL for CT, 1.6x104 CFU/mL for NG, 2.3x104 TV/mL for TV, and 1.1x106 GE/mL for MG. Of the 548 negative samples tested, 1 sample was reported positive for TV and 1 sample was reported as positive for both CT and TV. All negative samples were reported negative for NG and MG. The overall carryover rate for CT was 0.2% (1/548, 95% CI: 0.0% to 1.0%), the overall carryover rate for TV was 0.4% (2/548, 95% CI: 0.1% to 1.3% ), and the overall carryover rate for NG and MG was 0.0% (0/548, 95% CI: 0.0% to 0.7%). The overall sample carryover rate was 0.4% (2/548, 95% CI: 0.1% to 1.3%).

Reproducibility Study 5.7.1.8

Reproducibility performance of the Alinity m STI Assay was evaluated by testing panel members in 3 different sample matrices: urine matrix, swab matrix, and PreservCyt matrix. For each applicable specimen matrix, a 13-member panel was prepared with combinations of CT, NG, TV, and MG at sub-LoD (High Negative), claimed LoD, low positive (2x claimed LoD), high positive, and negative target levels. A total of 3 Alinity m STI AMP Kit lots were used. Each of the 3 clinical sites tested 2 Alinity m STI AMP Kit lots, on 5 non-consecutive days for each lot. A total of 5 replicates of each panel member were tested on each of 5 days. Each of the 3 clinical sites used different lots of Alinity m STI CTRL Kits and Alinity m Sample Prep Kit 1. The reproducibility results for CT, NG, TV, and MG are summarized in Table 12, Table 13, and Table 14, respectively.

31

Table 11. Reproducibility Analysis: CT Results
------------------------------------------------	--	--

| Matrix | Panel Description | Na | nb | Agreement
(n/N) | Mean
CN | Within-
Run/Day
Component | | Between-
Run/Day
Component | | Between-Lot
Component | | Between-Site
Component | | Totalc | | |
|------------|-----------------------------------------------------------|-----|-----|--------------------|--------------------|---------------------------------|---------------------------------|----------------------------------|----------------------------------|--------------------------|--------------------------|---------------------------|---------------------------|--------|--------|------|
| Urine | CT High Pos (NG, TV & MG High Pos) | 150 | 150 | 100.0% | 19.31 | 0.405 | 2.1 | 0.278 | 1.4 | 0.144 | 0.7 | 0.956 | 5.0 | 1.084 | 5.6 | |
| | CT High Pos (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 19.18 | 0.224 | 1.2 | 0.272 | 1.4 | 0.143 | 0.7 | 0.697 | 3.6 | 0.794 | 4.1 | |
| | CT at 2X LOD Claim (MG High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 31.50 | 0.243 | 0.8 | 0.209 | 0.7 | 0.114 | 0.4 | 0.592 | 1.9 | 0.683 | 2.2 | |
| | CT at 2X LOD Claim (TV High Pos, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.81 | 0.285 | 0.9 | 0.272 | 0.9 | 0.128 | 0.4 | 0.774 | 2.4 | 0.878 | 2.8 | |
| | CT at 2X LOD Claim (NG High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.47 | 0.189 | 0.6 | 0.270 | 0.9 | 0.000 | 0.0 | 0.609 | 1.9 | 0.692 | 2.2 | |
| | CT at 2X LOD Claim (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.34 | 0.200 | 0.6 | 0.262 | 0.8 | 0.063 | 0.2 | 0.561 | 1.8 | 0.654 | 2.1 | |
| | CT at 2X LOD Claim (CT only) | 150 | 150 | 100.0% | 31.29 | 0.182 | 0.6 | 0.244 | 0.8 | 0.148 | 0.5 | 0.402 | 1.3 | 0.526 | 1.7 | |
| | CT at LOD Claim | 150 | 149 | 99.3% | 32.05 | 0.344 | 1.1 | 0.157 | 0.5 | 0.245 | 0.8 | 0.464 | 1.4 | 0.647 | 2.0 | |
| | CT at Sub-LOD (High Negative) | 150 | 54 | 36.0% | 36.85 | 0.543 | 1.5 | 0.016 | 0.0 | 0.572 | 1.6 | 0.550 | 1.5 | 0.962 | 2.6 | |
| | CT Negatived | 600 | 600 | 100.0% | | | | | | | | | | | | |
| Swab | CT High Pos (NG, TV & MG High Pos) | 150 | 150 | 100.0% | 16.80 | 0.185 | 1.1 | 0.075 | 0.4 | 0.151 | 0.9 | 0.000 | 0.0 | 0.250 | 1.5 | |
| | CT High Pos (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 16.95 | 0.120 | 0.7 | 0.049 | 0.3 | 0.123 | 0.7 | 0.000 | 0.0 | 0.179 | 1.1 | |
| | CT at 2X LOD Claim (MG High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 29.59 | 0.147 | 0.5 | 0.097 | 0.3 | 0.133 | 0.4 | 0.000 | 0.0 | 0.221 | 0.7 | |
| | CT at 2X LOD Claim (TV High Pos, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.71 | 0.428 | 1.4 | 0.000 | 0.0 | 0.115 | 0.4 | 0.000 | 0.0 | 0.443 | 1.5 | |
| | CT at 2X LOD Claim (NG High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.53 | 0.159 | 0.5 | 0.104 | 0.4 | 0.130 | 0.4 | 0.000 | 0.0 | 0.230 | 0.8 | |
| | CT at 2X LOD Claim (NG, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 29.57 | 0.130 | 0.4 | 0.091 | 0.3 | 0.111 | 0.4 | 0.000 | 0.0 | 0.193 | 0.7 | |
| | CT at 2X LOD Claim (CT only) | 150 | 150 | 100.0% | 29.45 | 0.129 | 0.4 | 0.088 | 0.3 | 0.133 | 0.5 | 0.000 | 0.0 | 0.206 | 0.7 | |
| | CT at LOD Claim | 150 | 150 | 100.0% | 30.47 | 0.222 | 0.7 | 0.069 | 0.2 | 0.169 | 0.6 | 0.000 | 0.0 | 0.288 | 0.9 | |
| | CT at Sub-LOD (High Negative) | 150 | 54 | 36.0% | 36.94 | 0.900 | 2.4 | 0.000 | 0.0 | 0.940 | 2.5 | 0.000 | 0.0 | 1.301 | 3.5 | |
| | CT Negatived | 600 | 595 | 99.2% | | | | | | | | | | | | |
| | | | | | | Within-
Run/Day
Component | | Between-
Run/Day
Component | | Between-Lot
Component | | Between-Site
Component | | Totalc | | |
| Matrix | Panel Description | Na | nb | Agreement
(n/N) | Mean
CN | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | |
| Urine | NG High Pos (CT, TV & MG High Pos) | 150 | 150 | 100.0% | 24.85 | 0.513 | 2.1 | 1.162 | 4.7 | 0.547 | 2.2 | 0.448 | 1.8 | 1.453 | 5.8 | |
| | NG High Pos (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 26.05 | 0.436 | 1.7 | 1.136 | 4.4 | 0.594 | 2.3 | 0.974 | 3.7 | 1.668 | 6.4 | |
| | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 150 | 148 | 98.7% | 35.29 | 0.764 | 2.2 | 1.073 | 3.0 | 0.540 | 1.5 | 1.058 | 3.0 | 1.774 | 5.0 | |
| | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 34.70 | 0.735 | 2.1 | 1.089 | 3.1 | 0.160 | 0.5 | 0.760 | 2.2 | 1.526 | 4.4 | |
| | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 150 | 149 | 99.3% | 34.68 | 0.662 | 1.9 | 1.018 | 2.9 | 0.401 | 1.2 | 0.911 | 2.6 | 1.570 | 4.5 | |
| | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 150 | 147 | 98.0% | 35.37 | 1.004 | 2.8 | 1.093 | 3.1 | 0.679 | 1.9 | 1.037 | 2.9 | 1.934 | 5.5 | |
| | NG at 2X LOD Claim (NG only) | 150 | 145 | 96.7% | 35.84 | 0.767 | 2.1 | 0.677 | 1.9 | 0.796 | 2.2 | 1.025 | 2.9 | 1.652 | 4.6 | |
| | NG at LOD Claim | 150 | 141 | 94.0% | 36.20 | 0.931 | 2.6 | 1.110 | 3.1 | 0.526 | 1.5 | 0.870 | 2.4 | 1.770 | 4.9 | |
| | NG at Sub-LOD (High Negative) | 150 | 14 | 9.3% | 37.82 | 0.000 | 0.0 | 0.735 | 1.9 | 0.617 | 1.6 | 0.443 | 1.2 | 1.056 | 2.8 | |
| | NG Negatived | 600 | 600 | 100.0% | - | - | - | - | - | - | - | - | - | - | - | |
| Swab | NG High Pos (CT, TV & MG High Pos) | 150 | 150 | 100.0% | 21.77 | 0.259 | 1.2 | 0.172 | 0.8 | 0.112 | 0.5 | 0.000 | 0.0 | 0.331 | 1.5 | |
| | NG High Pos (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 22.51 | 0.289 | 1.3 | 0.268 | 1.2 | 0.000 | 0.0 | 0.197 | 0.9 | 0.440 | 2.0 | |
| | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 31.63 | 0.316 | 1.0 | 0.159 | 0.5 | 0.155 | 0.5 | 0.139 | 0.4 | 0.411 | 1.3 | |
| | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.44 | 0.275 | 0.9 | 0.159 | 0.5 | 0.147 | 0.5 | 0.000 | 0.0 | 0.350 | 1.1 | |
| | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.68 | 0.294 | 0.9 | 0.262 | 0.8 | 0.000 | 0.0 | 0.136 | 0.4 | 0.417 | 1.3 | |
| | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.54 | 0.306 | 1.0 | 0.246 | 0.8 | 0.000 | 0.0 | 0.111 | 0.4 | 0.408 | 1.3 | |
| | NG at 2X LOD Claim (NG only) | 150 | 150 | 100.0% | 31.78 | 0.285 | 0.9 | 0.180 | 0.6 | 0.117 | 0.4 | 0.108 | 0.3 | 0.373 | 1.2 | |
| | NG at LOD Claim | 150 | 150 | 100.0% | 32.49 | 0.336 | 1.0 | 0.185 | 0.6 | 0.053 | 0.2 | 0.116 | 0.4 | 0.405 | 1.2 | |
| | NG at Sub-LOD (High Negative) | 150 | 80 | 53.3% | 36.95 | 0.934 | 2.5 | 0.000 | 0.0 | 0.126 | 0.3 | 0.163 | 0.4 | 0.956 | 2.6 | |
| | NG Negatived | 600 | 600 | 100.0% | - | - | - | - | - | - | - | - | - | - | - | |
| PreservCyt | NG High Pos (CT, TV & MG High Pos) | 150 | 150 | 100.0% | 21.64 | 0.322 | 1.5 | 0.182 | 0.8 | 0.086 | 0.4 | 0.169 | 0.8 | 0.415 | 1.9 | |
| | NG High Pos (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 25.30 | 0.239 | 0.9 | 0.198 | 0.8 | 0.055 | 0.2 | 0.097 | 0.4 | 0.329 | 1.3 | |
| | NG at 2X LOD Claim (MG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 31.08 | 0.285 | 0.9 | 0.231 | 0.7 | 0.142 | 0.5 | 0.000 | 0.0 | 0.394 | 1.3 | |
| | NG at 2X LOD Claim (TV High Pos, CT & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.16 | 0.271 | 0.9 | 0.176 | 0.6 | 0.000 | 0.0 | 0.085 | 0.3 | 0.334 | 1.1 | |
| | NG at 2X LOD Claim (CT High Pos, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 30.39 | 0.328 | 1.1 | 0.163 | 0.5 | 0.137 | 0.5 | 0.000 | 0.0 | 0.392 | 1.3 | |
| Matrix | Panel Description | Na | nb | Agreement
(n/N) | Mean
CN | Within-
Run/Day
Component | | Between-
Run/Day
Component | | Between-Lot
Component | | Between-Site
Component | | Totalc | | |
| | NG at 2X LOD Claim (CT, TV & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 32.06 | 0.376 | 1.2 | 0.309 | 1.0 | 0.225 | 0.7 | 0.000 | 0.0 | 0.536 | 1.7 | |
| | NG at 2X LOD Claim (NG only) | 150 | 150 | 100.0% | 30.48 | 0.318 | 1.0 | 0.245 | 0.8 | 0.240 | 0.8 | 0.128 | 0.4 | 0.485 | 1.6 | |
| | NG at LOD Claim | 150 | 150 | 100.0% | 33.10 | 0.413 | 1.2 | 0.166 | 0.5 | 0.193 | 0.6 | 0.000 | 0.0 | 0.486 | 1.5 | |
| | NG at Sub-LOD (High Negative) | 150 | 63 | 42.0% | 37.46 | 0.742 | 2.0 | 0.000 | 0.0 | 0.323 | 0.9 | 0.000 | 0.0 | 0.810 | 2.2 | |
| | NG Negatived | 600 | 598 | 99.7% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | |
| | Panel Description | | Na | nb | Agreement
(n/N) | Mean
CN | Within-
Run/Day
Component | | Between-
Run/Day
Component | | Between-Lot
Component | | Between-Site
Component | | TotalC | |
| Matrix | | | | | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| Urine | TV High Pos (CT, NG & MG High Pos) | | 150 | 150 | 100.0% | 11.58 | 0.606 | 5.2 | 0.387 | 3.3 | 0.000 | 0.0 | 0.979 | 8.5 | 1.215 | 10.5 |
| | TV High Pos (CT, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 11.45 | 0.328 | 2.9 | 0.409 | 3.6 | 0.000 | 0.0 | 0.780 | 6.8 | 0.940 | 8.2 |
| | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | | 150 | 150 | 100.0% | 31.61 | 0.364 | 1.2 | 0.251 | 0.8 | 0.253 | 0.8 | 0.687 | 2.2 | 0.855 | 2.7 |
| | TV at 2X LOD Claim (NG High Pos, CT & MG at 2X LOD Claim) | | 150 | 149 | 99.3% | 31.38 | 0.445 | 1.4 | 0.369 | 1.2 | 0.076 | 0.2 | 0.568 | 1.8 | 0.814 | 2.6 |
| | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 31.56 | 0.397 | 1.3 | 0.206 | 0.7 | 0.321 | 1.0 | 0.692 | 2.2 | 0.884 | 2.8 |
| | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 31.09 | 0.315 | 1.0 | 0.278 | 0.9 | 0.103 | 0.3 | 0.642 | 2.1 | 0.775 | 2.5 |
| | TV at 2X LOD Claim (TV only) | | 150 | 150 | 100.0% | 31.34 | 0.465 | 1.5 | 0.087 | 0.3 | 0.307 | 1.0 | 0.205 | 0.7 | 0.600 | 1.9 |
| | TV at LOD Claim | | 150 | 149 | 99.3% | 31.75 | 0.357 | 1.1 | 0.156 | 0.5 | 0.229 | 0.7 | 0.521 | 1.6 | 0.690 | 2.2 |
| | TV at Sub-LOD (High Negative) | | 150 | 56 | 37.3% | 34.88 | 0.937 | 2.7 | 0.227 | 0.7 | 0.485 | 1.4 | 0.314 | 0.9 | 1.124 | 3.2 |
| | TV Negatived | | 600 | 596 | 99.3% | | | | | | | | | | | |
| Swab | TV High Pos (CT, NG & MG High Pos) | | 150 | 150 | 100.0% | 10.43 | 0.312 | 3.0 | 0.145 | 1.4 | 0.322 | 3.1 | 0.000 | 0.0 | 0.472 | 4.5 |
| | TV High Pos (CT, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 10.47 | 0.715 | 6.8 | 0.131 | 1.2 | 0.275 | 2.6 | 0.000 | 0.0 | 0.778 | 7.4 |
| | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | | 150 | 150 | 100.0% | 29.29 | 0.494 | 1.7 | 0.283 | 1.0 | 0.116 | 0.4 | 0.000 | 0.0 | 0.581 | 2.0 |
| | TV at 2X LOD Claim (NG High Pos, CT & NG at 2X LOD Claim) | | 150 | 150 | 100.0% | 29.22 | 0.336 | 1.1 | 0.234 | 0.8 | 0.364 | 1.2 | 0.000 | 0.0 | 0.548 | 1.9 |
| | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 29.33 | 0.349 | 1.2 | 0.134 | 0.5 | 0.364 | 1.2 | 0.000 | 0.0 | 0.522 | 1.8 |
| | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 29.05 | 0.200 | 0.7 | 0.142 | 0.5 | 0.273 | 0.9 | 0.000 | 0.0 | 0.367 | 1.3 |
| | TV at 2X LOD Claim (TV only) | | 150 | 150 | 100.0% | 29.69 | 0.269 | 0.9 | 0.173 | 0.6 | 0.222 | 0.7 | 0.064 | 0.2 | 0.394 | 1.3 |
| | TV at LOD Claim | | 150 | 150 | 100.0% | 29.77 | 0.395 | 1.3 | 0.658 | 2.2 | 0.000 | 0.0 | 0.000 | 0.0 | 0.767 | 2.6 |
| | TV at Sub-LOD (High Negative) | | 150 | 74 | 49.3% | 34.22 | 1.272 | 3.7 | 0.918 | 2.7 | 0.522 | 1.5 | 0.000 | 0.0 | 1.653 | 4.8 |
| | TV Negatived | | 600 | 596 | 99.3% | | | | | | | | | | | |
| PreservCyt | TV High Pos (CT, NG & MG High Pos) | | 150 | 150 | 100.0% | 9.53 | 0.235 | 2.5 | 0.112 | 1.2 | 0.371 | 3.9 | 0.000 | 0.0 | 0.453 | 4.8 |
| | TV High Pos (CT, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 8.96 | 0.233 | 2.6 | 0.137 | 1.5 | 0.300 | 3.3 | 0.000 | 0.0 | 0.404 | 4.5 |
| | TV at 2X LOD Claim (MG High Pos, CT & NG at 2X LOD Claim) | | 150 | 150 | 100.0% | 27.32 | 0.419 | 1.5 | 0.166 | 0.6 | 0.226 | 0.8 | 0.000 | 0.0 | 0.505 | 1.8 |
| | TV at 2X LOD Claim (NG High Pos, CT & NG at 2X LOD Claim) | | 150 | 150 | 100.0% | 27.61 | 0.207 | 0.7 | 0.170 | 0.6 | 0.114 | 0.4 | 0.066 | 0.2 | 0.299 | 1.1 |
| | TV at 2X LOD Claim (CT High Pos, NG & MG at 2X LOD Claim) | | 150 | 150 | 100.0% | 26.77 | 0.559 | 2.1 | 0.262 | 1.0 | 0.229 | 0.9 | 0.000 | 0.0 | 0.658 | 2.5 |
| Matrix | Panel Description | Na | nb | Agreement
(n/N) | Mean
CN | Within-
Run/Day
Component | | Between-
Run/Day
Component | | Between-Lot
Component | | Between-Site
Component | | Totalc | | |
| | TV at 2X LOD Claim (CT, NG & MG at 2X LOD Claim) | 150 | 150 | 100.0% | 28.39 | 0.380 | 1.3 | 0.213 | 0.7 | 0.152 | 0.5 | 0.000 | 0.0 | 0.461 | 1.6 | |
| | TV at 2X LOD Claim (TV only) | 150 | 150 | 100.0% | 28.37 | 0.327 | 1.2 | 0.070 | 0.2 | 0.167 | 0.6 | 0.000 | 0.0 | 0.374 | 1.3 | |
| | TV at LOD Claim | 150 | 150 | 100.0% | 29.32 | 0.599 | 2.0 | 0.000 | 0.0 | 0.184 | 0.6 | 0.081 | 0.3 | 0.632 | 2.2 | |
| | TV at Sub-LOD (High Negative) | 150 | 44 | 29.3% | 34.77 | 1.045 | 3.0 | 0.178 | 0.5 | 0.222 | 0.6 | 0.000 | 0.0 | 1.083 | 3.1 | |
| | TV Negatived | 600 | 581 | 96.8% | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | |

a N: Total number of replicates

º 1: Number of replicats with deectable and non-detected for negative parel; the number of replicates were used for the Mean and SD calculation.

& Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components.

d The negative panel included 4 panel members negative for CT

32

Table 12 Reproducibility Analysis: NG Results

33

Table 12 Reproducibility Analysis: NG Results

a N: total numberof replicates

b n: Number of replicates with detectable and non-letected for negative parel; the minter of replicates were used for the Mean and SD calculation.

C Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components.

d The negative panel included 4 panel members negative for NG.

34

Table 13. Reproducibility Analysis: TV Results

35

Table 13. Reproducibility Analysis: TV Results

a N: Total number of replicates

b n: Number of replicates with deectable and non-letected for negative parel; the minter of replicates were used for the Mean and SD calculation.

C Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components.

d The negative panel included 4 panel members negative for TV.

36

| | | | | | | Within-
Run/Day
Component | | Between-
Run/Day
Component | | Between-Lot
Component | | Between-Site
Component | | Totalc | |
|--------|-----------------------------------------------------------|-----|-----|--------------------|------------|---------------------------------|------|----------------------------------|------|--------------------------|------|---------------------------|------|--------|------|
| Matrix | Panel Description | Na | nb | Agreement
(n/N) | Mean
CN | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| Urine | MG High Pos (CT, NG & TV High Pos) | 150 | 150 | 100.0% | 22.66 | 0.428 | 1.9 | 0.228 | 1.0 | 0.329 | 1.5 | 0.906 | 4.0 | 1.079 | 4.8 |
| | MG High Pos (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 22.67 | 0.292 | 1.3 | 0.266 | 1.2 | 0.231 | 1.0 | 0.708 | 3.1 | 0.843 | 3.7 |
| | MG at 2X LOD Claim (TV High Pos, CT & NG at 2X LOD Claim) | 150 | 150 | 100.0% | 33.73 | 0.497 | 1.5 | 0.309 | 0.9 | 0.341 | 1.0 | 0.945 | 2.8 | 1.163 | 3.4 |
| | MG at 2X LOD Claim (NG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 33.18 | 0.382 | 1.2 | 0.304 | 0.9 | 0.033 | 0.1 | 0.825 | 2.5 | 0.959 | 2.9 |
| | MG at 2X LOD Claim (CT High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 33.18 | 0.368 | 1.1 | 0.257 | 0.8 | 0.353 | 1.1 | 0.704 | 2.1 | 0.907 | 2.7 |
| | MG at 2X LOD Claim (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 32.85 | 0.312 | 0.9 | 0.292 | 0.9 | 0.267 | 0.8 | 0.734 | 2.2 | 0.890 | 2.7 |
| | MG at 2X LOD Claim (MG only) | 150 | 150 | 100.0% | 33.01 | 0.274 | 0.8 | 0.199 | 0.6 | 0.295 | 0.9 | 0.340 | 1.0 | 0.564 | 1.7 |
| | MG at LOD Claim | 150 | 150 | 100.0% | 33.71 | 0.645 | 1.9 | 0.118 | 0.4 | 0.362 | 1.1 | 0.723 | 2.1 | 1.041 | 3.1 |
| | MG at Sub-LOD (High Negative) | 150 | 55 | 36.7% | 40.29 | 1.021 | 2.5 | 0.076 | 0.2 | 0.854 | 2.1 | 0.000 | 0.0 | 1.333 | 3.3 |
| | MG Negatived | 600 | 600 | 100.0% | | | | | | | | | | | |
| Swab | MG High Pos (CT, NG & TV High Pos) | 150 | 150 | 100.0% | 19.73 | 0.225 | 1.1 | 0.101 | 0.5 | 0.292 | 1.5 | 0.000 | 0.0 | 0.382 | 1.9 |
| | MG High Pos (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 20.64 | 0.186 | 0.9 | 0.127 | 0.6 | 0.320 | 1.6 | 0.000 | 0.0 | 0.391 | 1.9 |
| | MG at 2X LOD Claim (TV High Pos, CT & NG at 2X LOD Claim) | 150 | 150 | 100.0% | 31.03 | 0.471 | 1.5 | 0.000 | 0.0 | 0.196 | 0.6 | 0.000 | 0.0 | 0.511 | 1.6 |
| | MG at 2X LOD Claim (NG High Pos, CT & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 30.80 | 0.189 | 0.6 | 0.121 | 0.4 | 0.250 | 0.8 | 0.000 | 0.0 | 0.336 | 1.1 |
| | MG at 2X LOD Claim (CT High Pos, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 30.87 | 0.159 | 0.5 | 0.046 | 0.1 | 0.236 | 0.8 | 0.000 | 0.0 | 0.288 | 0.9 |
| | MG at 2X LOD Claim (CT, NG & TV at 2X LOD Claim) | 150 | 150 | 100.0% | 30.69 | 0.165 | 0.5 | 0.124 | 0.4 | 0.225 | 0.7 | 0.000 | 0.0 | 0.305 | 1.0 |
| | MG at 2X LOD Claim (MG only) | 150 | 150 | 100.0% | 31.40 | 0.180 | 0.6 | 0.083 | 0.3 | 0.238 | 0.8 | 0.000 | 0.0 | 0.310 | 1.0 |
| | MG at LOD Claim | 150 | 150 | 100.0% | 31.58 | 0.244 | 0.8 | 0.034 | 0.1 | 0.304 | 1.0 | 0.000 | 0.0 | 0.391 | 1.2 |
| | MG at Sub-LOD (High Negative) | 150 | 102 | 68.0% | 36.54 | 0.571 | 1.6 | 0.151 | 0.4 | 0.048 | 0.1 | 0.164 | 0.4 | 0.614 | 1.7 |
| | MG Negatived | 600 | 599 | 99.8% | | | | | | | | | | | |

Table 14. Reproducibility Analysis: MG Results

a N: total numberof replicates

b n: Number of replicates with deectable and non-detected for negative parel; the minter of replicates were used for the Mean and SD calculation

C Total includes Within-Run/Day, Between-Run/Day, Between-Lot and Between-Site Components

d The negative panel included 4 panel members negative for MG.

37

5.7.2 Clinical Performance

Clinical Study Results - Urogenital Specimens 5.7.2.1

Performance characteristics of the Alinity m STI Assay with urogenital specimens were established in a multicenter clinical study conducted in the United States. Specimens were collected from subjects 14 years of age or older at 33 geographically diverse sites that included but were not limited to STI clinics, primary care offices, and gynecology practices. A total of 7,099 male and female, asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STI related symptoms.

Each female subject provided up to 8 specimens, including 1 urine specimen, 1 selfcollected vaginal swab, 3 clinician-collected vaginal swabs, 2 endocervical swabs, and 1 ThinPrep (PreservCyt) cytology specimen. Each male provided 1 urine specimen.

Specimen testing methods included the Alinity m STI Assay and comparator assays for CT, NG, TV, and MG. Alinity m STI testing was performed at 3 external clinical testing sites. Comparator assays for CT and NG included 2 commercially available nucleic acid amplification tests (NAAT) for females (each NAAT tested with 1 swab and 1 urine specimen) and 3 commercially available NAATs for males (each NAAT tested with urine). Comparator assays for TV included 3 NAATs tested with swab specimens and 2 NAATs tested with urine specimens for females and 2 NAATs and culture tested with urine for males. Comparator assays for MG included 3 NAATs for females (each tested with a vaginal swab) and males (each tested with urine).

For each subject, a patient infected status (PIS) was determined based on the combined results from the comparator assays. A female subject was categorized as infected for CT or NG if a minimum of 2 positive results (at least 1 from each comparator NAAT) was reported. For CT, female subjects with positive results on both comparator urine specimens and negative results on both comparator swab specimens (endocervical swab from NAAT 1 and clinician-collected vaginal swab specimens from NAAT 2) were categorized as infected for urine and not infected for swab specimens (there were 2 female subjects that were negative for CT in the swab samples and positive in urine by

38

both comparator NAATs). A female subject was categorized as not infected for CT or NG if at least 1 of the comparator NAATs reported negative results for all sample types. Refer to Table 20, Table 21, Table 24 and Table 25 for the female PIS algorithm. A female subject was categorized as infected for TV or MG if the first 2 swab comparator NAAT results were both positive or if 2 of the 3 swab comparator NAAT results were positive in cases where the 3ª NAAT was used as a tie-breaker. A female subject was categorized as not infected for TV or MG if the first 2 swab comparator NAAT results were both negative or if 2 of the 2 swab comparator NAAT results were negative in cases where 3rd NAAT was used as a tie-breaker. Refer to Table 28, Table 32 and Table 33 for the female PIS algorithm.

A male subject was categorized as infected for CT, NG, TV, or MG if a minimum of two comparator positive results was reported. If the comparator TV culture assay result was positive, the subject was categorized as infected for TV regardless of NAAT results. A male subject was categorized as not infected for CT, NG, or MG if two or more comparator NAAT results were negative. For TV, a male subject was categorized as not infected if the TV culture assay result was negative, and if one or more comparator NAATs were negative. Refer to Table 22, Table 26, Table 26, Table 27, Table 30, Table 31, Table 34 and Table 35 for the male PIS algorithm.

If a PIS could not be determined due to missing and/or indeterminate results from the comparator assays, the subject was excluded from the analysis for that analyte. Out of 7099 subjects, PIS could not be determined for 1 or more analytes for 171 subjects (42 subjects for CT, 32 subjects for NG, 73 subjects for TV, 93 subjects for MG).

Alinity m STI test results were compared to the PIS for calculation of assay sensitivity and specificity. A total of 12,903 CT, 15,655 NG, 18,843 TV, and 12,829 MG results were used in the analysis. The results were analyzed by gender, specimen type, and the presence of symptoms. CT sensitivity and specificity for female and male subjects by specimen type and by symptom status are presented in Table 15. NG sensitivity and specificity for female and male subjects by specimen type and by symptom status are presented in Table 16. TV sensitivity and specificity for female and male subjects by

39

specimen type and by symptom status are presented in Table 17. MG sensitivity and specificity for female and male subjects by specimen type and by symptom status are presented in Table 19.

For the urogenital study, approximately 4.7% of sample results were invalid on the initial test. Specimens with initial invalid results were retested. Out of a total of 20,145 specimens, the number of specimens with final invalid results for CT, NG, TV and MG were 37, 49, 54 and 38, respectively, or approximately 0.3%.

40

| Gender | Specimen Type | Symptom Status | N | TP | FP | TN | FN | Sensitivity (%)
Estimate (95% CI) | n / N | Specificity
Estimate (95% CI) | n / N |
|--------|-----------------------------------|----------------|------|-----|----|------|----|--------------------------------------|---------|----------------------------------|-----------|
| Female | Clinician-collect
Vaginal Swab | Symptomatic | 1517 | 119 | 18 | 1378 | 2 | 98.3 (94.2,99.5) | 119/121 | 98.7 (98.0,99.2) | 1378/1396 |
| | | Asymptomatic | 1649 | 82 | 7 | 1558 | 2 | 97.6 (91.7,99.3) | 82/84 | 99.6 (99.1,99.8) | 1558/1565 |
| | | All | 3166 | 201 | 25 | 2936 | 4 | 98.0 (95.1,99.2) | 201/205 | 99.2 (98.8,99.4) | 2936/2961 |
| | Self-collect
Vaginal Swab | Symptomatic | 1521 | 121 | 14 | 1383 | 3 | 97.6 (93.1,99.2) | 121/124 | 99.0 (98.3,99.4) | 1383/1397 |
| | | Asymptomatic | 1642 | 82 | 8 | 1552 | 0 | 100.0 (95.5,100.0) | 82/82 | 99.5 (99.0,99.7) | 1552/1560 |
| | | All | 3163 | 203 | 22 | 2935 | 3 | 98.5 (95.8,99.5) | 203/206 | 99.3 (98.9,99.5) | 2935/2957 |
| | Endocervical Swab | Symptomatic | 1495 | 113 | 8 | 1369 | 5 | 95.8 (90.5,98.2) | 113/118 | 99.4 (98.9,99.7) | 1369/1377 |
| | | Asymptomatic | 1592 | 75 | 10 | 1501 | 6 | 92.6 (84.8,96.6) | 75/81 | 99.3 (98.8,99.6) | 1501/1511 |
| | | All | 3087 | 188 | 18 | 2870 | 11 | 94.5 (90.4,96.9) | 188/199 | 99.4 (99.0,99.6) | 2870/2888 |
| Male | Male Urine | Symptomatic | 1107 | 123 | 2 | 979 | 3 | 97.6 (93.2,99.2) | 123/126 | 99.8 (99.3,99.9) | 979/981 |
| | | Asymptomatic | 2380 | 155 | 14 | 2206 | 5 | 96.9 (92.9,98.7) | 155/160 | 99.4 (98.9,99.6) | 2206/2220 |
| | | All | 3487 | 278 | 16 | 3185 | 8 | 97.2 (94.6,98.6) | 278/286 | 99.5 (99.2,99.7) | 3185/3201 |

Table 15. CT Clinical Sensitivity and Specificity by Gender, Specimen Type and Symptom Status for Urogenital Specimens

Two subjects tested negative for CT by both comparators in the swab specimens in urine specimens. For calculations of performance, these samples were consider for swab samples and PIS CT Positive for urine samples.

41

| Gender | Specimen Type | Symptom Status | N | TP | FP | TN | FN | Sensitivity (%)
Estimate
(95% CI) | n/N | Specificity (%)
Estimate
(95% CI) | n/N |
|--------|-----------------------------------|----------------|------|-----|----|------|----|-----------------------------------------|---------|-----------------------------------------|-----------|
| Female | Clinician-collect
Vaginal Swab | Symptomatic | 1519 | 23 | 3 | 1493 | 0 | 100.0 (85.7,100.0) | 23/23 | 99.8 (99.4,99.9) | 1493/1496 |
| | | Asymptomatic | 1651 | 18 | 4 | 1629 | 0 | 100.0 (82.4,100.0) | 18/18 | 99.8 (99.4,99.9) | 1629/1633 |
| | | All | 3170 | 41 | 7 | 3122 | 0 | 100.0 (91.4,100.0) | 41/41 | 99.8 (99.5,99.9) | 3122/3129 |
| | Self-collect
Vaginal Swab | Symptomatic | 1523 | 23 | 5 | 1495 | 0 | 100.0 (85.7,100.0) | 23/23 | 99.7 (99.2,99.9) | 1495/1500 |
| | | Asymptomatic | 1643 | 18 | 5 | 1620 | 0 | 100.0 (82.4,100.0) | 18/18 | 99.7 (99.3,99.9) | 1620/1625 |
| | | All | 3166 | 41 | 10 | 3115 | 0 | 100.0 (91.4,100.0) | 41/41 | 99.7 (99.4,99.8) | 3115/3125 |
| | Endocervical Swab | Symptomatic | 1497 | 19 | 5 | 1470 | 3a | 86.4 (66.7,95.3) | 19/22 | 99.7 (99.2,99.9) | 1470/1475 |
| | | Asymptomatic | 1593 | 18 | 2 | 1573 | 0 | 100.0 (82.4,100.0) | 18/18 | 99.9 (99.5,100.0) | 1573/1575 |
| | | All | 3090 | 37 | 7 | 3043 | 3a | 92.5 (80.1,97.4) | 37/40 | 99.8 (99.5,99.9) | 3043/3050 |
| | PreservCyt | Symptomatic | 1349 | 19 | 1 | 1327 | 2 | 90.5 (71.1,97.3) | 19/21 | 99.9 (99.6,100.0) | 1327/1328 |
| | | Asymptomatic | 1387 | 15 | 0 | 1372 | 0 | 100.0 (79.6,100.0) | 15/15 | 100.0 (99.7,100.0) | 1372/1372 |
| | | All | 2736 | 34 | 1 | 2699 | 2 | 94.4 (81.9,98.5) | 34/36 | 100.0 (99.8,100.0) | 2699/2700 |
| Male | Male Urine | Symptomatic | 1109 | 74 | 2 | 1033 | 0 | 100.0 (95.1,100.0) | 74/74 | 99.8 (99.3,99.9) | 1033/1035 |
| | | Asymptomatic | 2384 | 28 | 3 | 2353 | 0 | 100.0 (87.9,100.0) | 28/28 | 99.9 (99.6,100.0) | 2353/2356 |
| | | All | 3493 | 102 | 5 | 3386 | 0 | 100.0 (96.4,100.0) | 102/102 | 99.9 (99.7,99.9) | 3386/3391 |

Table 16. NG Clinical Sensitivity and Specificity by Gender, Specimen Type and Symptom Status for Urogenital Specimens

ª A false negative test result was obtainen which was collected after 2 other swabs were collected from the cervix (ic, last of the 3 swabs). Based on the CN values from the Cellular Control, the false negative result was likely due to insufficient cellular material collected. Without this sample, the overall sensitivity of NG is 94.9% (37/39) with a 95% confidence interval of (83.1%, Refer to the limitations section for caution when collecting multiple cervical specimens.

42

								Sensitivity (%)			Specificity (%)
Gender	Specimen Type	Symptom Status	N	TP	FP	TN	FN	Estimate
(95% CI)	n / N	Estimate
(95% CI)	n / N
Female	Clinician-collect
Vaginal Swab	Symptomatic	1518	157	35	1325	1	99.4 (96.5,99.9)	157/158	97.4 (96.4,98.1)	1325/1360
	Vaginal Swab	Asymptomatic	1654	159	44	1451	0	100.0 (97.6,100.0)	159/159	97.1 (96.1,97.8)	1451/1495
		All	3172	316	79	2776	1	99.7 (98.2,99.9)	316/317	97.2 (96.6,97.8)	2776/2855
	Self-collect
Vaginal Swab	Symptomatic	1522	157	27	1337	1	99.4 (96.5,99.9)	157/158	98.0 (97.1,98.6)	1337/1364
	Vaginal Swab	Asymptomatic	1644	155	35	1453	1	99.4 (96.5,99.9)	155/156	97.6 (96.7,98.3)	1453/1488
		All	3166	312	62	2790	2	99.4 (97.7,99.8)	312/314	97.8 (97.2,98.3)	2790/2852
	Endocervical Swab	Symptomatic	1496	152	46	1295	3	98.1 (94.5,99.3)	152/155	96.6 (95.5,97.4)	1295/1341
		Asymptomatic	1597	152	39	1402	4	97.4 (93.6,99.0)	152/156	97.3 (96.3,98.0)	1402/1441
		All	3093	304	85	2697	7	97.7 (95.4,98.9)	304/311	96.9 (96.2,97.5)	2697/2782
	PreservCyt	Symptomatic	1337	131	5	1197	4	97.0 (92.6,98.8)	131/135	99.6 (99.0,99.8)	1197/1202
		Asymptomatic	1386	127	9	1242	8	94.1 (88.7,97.0)	127/135	99.3 (98.6,99.6)	1242/1251
		All	2723	258	14	2439	12	95.6 (92.4,97.4)	258/270	99.4 (99.0,99.7)	2439/2453
Male	Male Urine	Symptomatic	1109	24	9	1076	0	100.0 (86.2,100.0)	24/24	99.2 (98.4,99.6)	1076/1085
		Asymptomatic	2385	54	17	2313	1	98.2 (90.4,99.7)	54/55	99.3 (98.8,99.5)	2313/2330
		All	3494	78	26	3389	1	98.7 (93.2,99.8)	78/79	99.2 (98.9,99.5)	3389/3415

Table 17. TV Clinical Sensitivity and Specificity by Gender, Specimen Type and Symptom Status for Urogenital Specimens

For female urine, the TV result of the Alinity m STI Assay was compared against a specimen-specific agreement.. A female urine specimen was considered positive for TV if at least 1 comparator NAAT was positive for the urine specimen. A female urine specimen was considered negative if both comparator NAATs were negative for the urine specimen. If a TV specimen-specific status for female urine could not be determined due to missing and/or indeterminate results from the urine comparator assays, the subject was excluded from the analysis for that analyte. The specimen-specific TV status could not be determined for 37 subjects. TV specimen-specific positive and negative agreement for female urine by symptom status are presented in Table 18. The TV clinical sensitivity based on the PIS was up to 6.6% lower in female urine than in vaginal swab specimens.

43

								PPA
Analyte	Specimen
Type	Symptom
Status	N	Alinity +
CCA+	Alinity+
CCA-	Alinity-
CCA-	Alinity-
CCA+	Estimate
(95% CI)	n / N	Estimate
(95% CI)	n / N
TV	Female
Urine	Symptomatic	1507	141	16	1346	4	97.2
(93.1,98.9)	141/145	98.8
(98.1,99.3)	1346/1362
		Asymptomatic	1651	154	10	1484	3	98.1
(94.5,99.3)	154/157	99.3
(98.8,99.6)	1484/1494
		All	3158	295	26	2830	7	97.7
(95.3,98.9)	295/302	99.1
(98.7,99.4)	2830/2856

Table 19. MG Clinical Sensitivity and Specificity by Gender, Specimen Type and Symptom Status for Urogenital Specimens

								Sensitivity (%)		Specificity (%)
Gender	Specimen Type	Symptom Status	N	TP	FP	TN	FN	Estimate
(95% CI)	n / N	Estimate
(95% CI)	n / N
Female	Clinician-collect
Vaginal Swab	Symptomatic	1514	148	15	1350	1	99.3 (96.3,99.9)	148/149	98.9 (98.2,99.3)	1350/1365
	Vaginal Swab	Asymptomatic	1643	105	8	1526	4	96.3 (90.9,98.6)	105/109	99.5 (99.0,99.7)	1526/1534
		All	3157	253	23	2876	5	98.1 (95.5,99.2)	253/258	99.2 (98.8,99.5)	2876/2899
	Self-collect
Vaginal Swab	Symptomatic	1517	144	21	1346	6	96.0 (91.5,98.2)	144/150	98.5 (97.7,99.0)	1346/1367
	Vaginal Swab	Asymptomatic	1632	104	20	1502	6	94.5 (88.6,97.5)	104/110	98.7 (98.0,99.1)	1502/1522
		All	3149	248	41	2848	12	95.4 (92.1,97.3)	248/260	98.6 (98.1,99.0)	2848/2889
	Endocervical Swab	Symptomatic	1492	125	10	1336	21	85.6 (79.0,90.4)	125/146	99.3 (98.6,99.6)	1336/1346
		Asymptomatic	1584	82	14	1466	22	78.8 (70.0,85.6)	82/104	99.1 (98.4,99.4)	1466/1480
		All	3076	207	24	2802	43	82.8 (77.6,87.0)	207/250	99.2 (98.7,99.4)	2802/2826
Male	Male Urine	Symptomatic	1099	99	40	958	2	98.0 (93.1,99.5)	99/101	96.0 (94.6,97.0)	958/998
		Asymptomatic	2348	110	41	2195	2	98.2 (93.7,99.5)	110/112	98.2 (97.5,98.6)	2195/2236
		All	3447	209	81	3153	4	98.1 (95.3,99.3)	209/213	97.5 (96.9,98.0)	3153/3234

The numbers of specimens in all combinations of PIS, individual comparator results and Alinity m STI result are summarized. CT results for infected and non-infected female subjects are presented in Table 20 and Table 21, and for infected and non-infected male subjects in Table 22 and Table 23. NG results for infected and non-infected female subjects are presented in Table 24 and Table 25, and for infected and non-infected male subjects in Table 26 and Table 27. TV results for infected and non-infected female subjects are presented in Table 28 and Table 29, and for infected and non- infected male subjects in Table 30 and Table 31. MG results for infected and non-infected female subjects are presented in Table 32 and Table 33, and for infected and non-infected male subjects in Table 34 and Table 35.

44

NAAT 1		NAAT 2		Alinity m STI			No. of Subjects
E	FU	VS	FU	E	SCV	CCV	Symptomatic	Asymptomatic	Total
+	+	+	+	+	+	+	95	65	160
+	+	+	+	N/A	+	+	2	2	4
+	+	+	+	+	N/A	+	0	1	1
+	+	+	+	N/A	N/A	+	0	1	1
+	+	+	+	N/A	+	N/A	1	0	1
+	+	+	+	-	+	+	1	1	2
+	+	+	+	+	+	-	0	1	1
N/A	+	+	+	+	+	+	2	1	3
N/A	+	+	+	N/A	+	+	1	0	1
+	+	N/A	+	+	+	+	1	0	1
+	+	+	N/A	+	+	+	2	2	4
+	N/A	+	N/A	+	+	+	1	0	1
-	+	+	+	+	+	+	3	1	4
-	+	+	+	N/A	+	N/A	1	0	1
-	+	+	+	-	+	+	0	3	3
-	+	+	+	-	+	-	0	1	1
+	-	+	+	+	+	+	2	1	3
+	-	+	+	+	-	+	1	0	1
+	+	+	-	+	+	+	2	1	3
+	+	+	-	N/A	+	N/A	1	0	1
+	+	+	-	-	+	+	1	1	2
-	+	N/A	+	-	-	-	1	0	1
+	N/A	+	-	+	+	+	0	1	1
-	+	+	-	+	+	+	2	0	2
-	+	+	-	-	+	-	1	0	1
+	-	+	-	+	+	+	1	1	2
+	-	+	-	-	+	+	1	0	1
+	-	+	-	+	-	+	1	0	1
-	+	-	+	-	+	-	2	0	2

Table 20. CT Analysis Per Patient Infected Status- INFECTED FEMALE Subjects (Urogenital)

E = Endocervical Swab, VS = Vaginal Swab, FU = Fenale Urine, CCV = Clinician-Collected Vaginal Swab, SCV = Self Collected Vaginal Swab, N/A = Not Available

Two subjects tested negative for CT by both comparators in the swab specimens and positive by both comparators in urine specimens. For calculations of performance, these samples were considere for swab samples and PIS CT Positive for urine samples.

45

NAAT 1		NAAT 2		Alinity m STI			No. of Subjects
E	FU	VS	FU	E	SCV	CCV	Symptomatic	Asymptomatic	Total
-	-	-	-	-	-	-	1267	1405	2672
-	-	-	-	N/A	-	-	16	44	60
-	-	-	-	-	N/A	-	9	22	31
-	-	-	-	-	-	N/A	6	9	15
-	-	-	-	N/A	-	N/A	3	6	9
-	-	-	-	-	N/A	N/A	2	0	2
-	-	-	-	+	-	-	7	8	15
-	-	-	-	-	+	-	4	6	10
-	-	-	-	-	-	+	9	4	13
-	-	-	-	-	+	+	1	0	1
N/A	-	-	-	-	-	-	15	17	32
N/A	-	-	-	N/A	-	-	11	17	28
N/A	-	-	-	-	N/A	-	1	0	1
N/A	-	-	-	N/A	-	N/A	2	3	5
-	N/A	-	-	-	-	-	6	7	13
-	-	N/A	-	-	-	-	8	11	19
-	-	N/A	-	-	-	+	1	0	1
-	-	N/A	-	-	+	+	1	0	1
-	-	-	N/A	-	-	-	10	8	18
N/A	N/A	-	-	-	-	-	9	3	12
N/A	N/A	-	-	N/A	-	-	0	1	1
N/A	N/A	-	-	-	N/A	-	0	1	1
N/A	N/A	-	-	+	-	-	0	1	1
+	-			-	-	-	6	2	8
+	-			N/A	-	-	0	1	1
+	-	-		-	+	-	1	0	1
+	-	-	-	-	+	+	1	0	1
-	+	-	-	-	-	-	3	2	5
-	+	-	-	-	+	+	1	0	1
-	-	+	-	-	-	-	0	2	2

Table 21. CT Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

46

NAAT 1		NAAT 2		Alinity m STI			No. of Subjects
E	FU	VS	FU	E	SCV	CCV	Symptomatic	Asymptomatic	Total
-	-	+	-	-	+	-	1	0	1
-	-	+	-	-	-	+	2	1	3
-	-	+	-	-	+	+	1	1	2
-	-	+	-	+	+	+	0	1	1
-	-	-	+	N/A	-	N/A	1	0	1
+	+	-	-	+	-	-	1	0	1
-	-	+	+	-	+	+	1	0	1

Table 21. CT Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

E = Endocervical Swab, VS = Vaginal Swab, FU = Female Urine, CCV = Clinician-Collected Vaginal Swab, SCV = Self-Collected Vaginal Swab, N/A = Not Available

47

NAAT 1	NAAT 2	NAAT 3	Alinity m STI	Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
+	+	+	+	105	131	236
N/A	+	+	+	0	1	1
+	N/A	+	+	3	2	5
+	+	N/A	+	8	15	23
-	+	+	+	2	2	4
+	-	+	+	2	3	5
+	+	-	+	3	1	4
+	+	+	-	2	3	5
+	+	N/A	-	0	2	2
+	-	+	-	1	0	1

Table 22. CT Analysis Per Patient Infected Status- INFECTED MALE Subjects (Urogenital)

MU = Male Urine, N/A = Not Available

NAAT 1	NAAT 2	NAAT 3	Alinity m STI	Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
-	-	-	-	874	1665	2539
N/A	-	-	-	3	12	15
-	N/A	-	-	4	11	15
-	-	N/A	-	96	510	606
+	-	-	-	1	4	5
-	+	-	-	1	1	2
-	-	+	-	0	3	3
-	-	-	+	2	12	14
-	+	-	+	0	2	2

Table 23 CT Ar 187 cia Da Patie nt Infected Stati NOT INFECTED MALE Subje

MU = Male Urine, N/A = Not Available

48

	NAAT 1		NAAT 2		Alinity m STI				No. of Subjects
	E	FU	VS	FU	E	SCV	CCV	PreservCyt	Symptomatic	Asymptomatic	Total
	+	+	+	+	+	+	+	+	12	12	24
	+	+	+	+	+	+	+	N/A	0	2	2
	+	+	+	+	N/A	+	+	N/A	1	0	1
	N/A	+	+	+	+	+	+	+	1	0	1
	+	+	+	N/A	+	+	+	+	0	2	2
	+	+	+	N/A	+	+	+	N/A	1	0	1
	+	N/A	+	N/A	+	+	+	+	1	0	1
	+	-	+	+	+	+	+	+	3	1	4
	+	-	+	+	+	+	+	-	1	0	1
	+	+	+	-	-	+	+	-	1	0	1
	+	-	+	N/A	+	+	+	+	1	0	1
	+	-	+	-	+	+	+	N/A	0	1	1
	+	-	+	-	+	+	+	+	1	0	1
	NAAT 1		NAAT 2			Alinity m STI		No. of Subjects
E	FU	VS	FU	E	SCV	CCV	PreservCyt	Symptomatic	Asymptomatic	Total
-	-	-	-	-	-	-	-	1219	1261	2480
-	-	-	-	N/A	-	-	-	7	9	16
-	-	-	-	-	N/A	-	-	10	21	31
-	-	-	-	-	-	N/A	-	6	8	14
-	-	-	-	-	-	-	N/A	169	223	392
-	-	-	-	N/A	N/A	-	-	0	1	1
-	-	-	-	N/A	-	N/A	-	0	1	1
-	-	-	-	N/A	-	-	N/A	10	38	48
-	-	-	-	-	N/A	N/A	-	2	0	2
-	-	-	-	-	N/A	-	N/A	0	2	2
-	-	-	-	N/A	N/A	N/A	-	0	3	3
-	-	-	-	N/A	-	N/A	N/A	7	5	12
-	-	-	-	+	-	-	-	4	1	5
-	-	-	-	-	+	-	-	4	1	5
-	-	-	-	-	-	+	-	3	1	4
-	-	-	-	-	-	-	+	1	0	1
-	-	-	-	+	-	-	N/A	1	0	1
-	-	-	-	-	+	N/A	-	0	1	1
-	-	-	-	-	+	-	N/A	1	0	1
-	-	-	-	-	+	+	-	0	1	1
-	-	-	-	-	+	+	N/A	0	1	1
N/A	-	-	-	-	-	-	-	21	19	40
N/A	-	-	-	N/A	-	-	-	6	6	12
N/A	-	-	-	-	N/A	-	-	1	0	1
N/A	-	-	-	-	-	-	N/A	1	1	2
N/A	-	-	-	N/A	-	N/A	-	2	3	5
N/A	-	-	-	N/A	-	-	N/A	6	11	17
N/A	-	-	-	N/A	N/A	N/A	-	11	2	13
N/A	-	-	-	N/A	N/A	-	N/A	0	1	1
-	N/A	-	-	-	-	-	-	5	6	11
-	N/A	-	-	-	-	-	N/A	1	2	3
NAAT 1		NAAT 2		Alinity m STI				No. of Subjects
E	FU	VS	FU	E	SCV	CCV	PreservCyt	Symptomatic	Asymptomatic	Total
-	-	N/A	-	-	-	-	-	4	9	13
-	-	N/A	-	-	-	-	N/A	0	1	1
-	-	N/A	-	N/A	N/A	N/A	-	0	1	1
-	-	-	N/A	-	-	-	-	11	8	19
N/A	N/A	-	-	-	-	-	-	10	4	14
N/A	N/A	-	-	N/A	-	-	-	0	1	1
N/A	N/A	-	-	-	N/A	-	-	0	1	1
-	+	-	-	-	-	-	-	0	1	1
-	-	+	-	-	-	-	-	0	1	1
-	-	+	-	+	+	+	-	0	1	1
+	+	-	-	-	-	-	-	1	0	1

Table 24. NG Analysis Per Patient Infected Status- INFECTED FEMALE Subjects (Urogenital)

E = Endocervical Swab, VS = Vaginal Swab, FU = Female Urine, CCV = Clinician-Collected Vaginal Swab, SCV = Self Collected

Vaginal Swab, N/A = Not Available

49

Table 25. NG Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

50

Table 25. NG Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

E = Endocervical Swab, VS = Vaginal Swab, FU = Female Urine, CCV = Clinician-Collected Vaginal Swab, N/A = Not Available

NAAT 1	NAAT 2	NAAT 3	Alinity m STI	Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
+	+	+	+	69	21	90
N/A	+	+	+	0	1	1
+	N/A	+	+	1	0	1
+	+	N/A	+	3	6	9
+	+	-	+	1	0	1

Table 26. NG Analysis Per Patient Infected Status- INFECTED MALE Subjects (Urogenital)

MU = Male Urine, N/A = Not Available

51

NAAT 1	NAAT 2	NAAT 3	Alinity m STI		Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
-	-	-	-	921	1800	2721
N/A	-	-	-	3	12	15
-	N/A	-	-	4	12	16
-	-	N/A	-	102	525	627
+	-	-	-	1	1	2
-	+	-	-	1	1	2
-	-	+	-	1	2	3
-	-	-	+	2	3	5

Table 27. NG Analysis Per Patient Infected Status- NOT INFECTED MALE Subjects (Urogenital)

MU = Male Urine, N/A = Not Available

52

NAAT 1	NAAT 2	NAAT 3	Alinity m STI					Number of Subjects
E	VS	VS	E	SCV	CCV	FU	PreservCyt	Symptomatic	Asymptomatic	Total
+	+	N/A	+	+	+	+	+	113	109	222
+	+	N/A	+	N/A	+	+	+	2	3	5
+	+	N/A	+	+	+	N/A	+	2	1	3
+	+	N/A	+	+	+	+	N/A	19	16	35
+	+	N/A	N/A	+	+	+	N/A	1	2	3
+	+	N/A	N/A	+	N/A	+	N/A	1	0	1
+	+	N/A	N/A	N/A	N/A	N/A	N/A	0	3	3
+	+	N/A	+	+	+	+	+	5	3	8
+	+	N/A	+	+	+	+	+	0	2	2
+	+	N/A	+	+	+	+	N/A	0	2	2
+	+	N/A	+	+	+	-	-	0	1	1
N/A	+	+	+	+	+	+	+	2	3	5
N/A	+	+	N/A	+	N/A	+	+	1	0	1
N/A	+	+	N/A	+	+	+	N/A	1	1	2
+	N/A	+	+	+	+	+	+	1	1	2
-	+	+	+	+	+	+	+	2	5	7
-	+	+	+	+	+	+	N/A	0	1	1
-	+	+	N/A	+	+	+	N/A	1	0	1
-	+	+	+	+	+	-	+	2	1	3
-	+	+	+	+	+	+	-	1	2	3
-	+	+	-	+	+	+	N/A	2	0	2
-	+	+	+	+	+	-	N/A	0	2	2
-	+	+	-	+	+	-	+	0	1	1
-	+	+	-	+	+	+	-	0	2	2
-	+	+	+	+	+	-	-	2	0	2
-	+	+	-	-	+	-	-	1	1	2
+	-	+	+	+	+	-	+	1	0	1
	NAAT 1	NAAT 2	NAAT 3	Alinity m STI					Number of Subjects
E	VS	VS	E	SCV	CCV	FU	PreservCyt	Symptomatic	Asymptomatic	Total
-	-	N/A	-	-	-	-	-	1041	1034	2075
-	-	N/A	N/A	-	-	-	-	7	8	15
-	-	N/A	-	N/A	-	-	-	7	15	22
-	-	N/A	-	-	N/A	-	-	5	8	13
-	-	N/A	-	-	-	N/A	-	14	29	43
-	-	N/A	-	-	-	-	N/A	120	175	295
-	-	N/A	N/A	N/A	N/A	-	-	0	1	1
-	-	N/A	N/A	-	N/A	-	-	0	1	1
-	-	N/A	N/A	-	-	-	N/A	6	36	42
-	-	N/A	-	N/A	N/A	-	-	2	0	2
-	-	N/A	-	N/A	-	N/A	-	0	2	2
-	-	N/A	-	N/A	-	-	N/A	0	2	2
-	-	N/A	-	-	N/A	N/A	-	1	1	2
-	-	N/A	-	-	-	N/A	N/A	1	4	5
-	-	N/A	N/A	N/A	N/A	N/A	-	0	1	1
-	-	N/A	N/A	-	N/A	-	N/A	5	5	10
-	-	N/A	N/A	-	-	N/A	N/A	1	0	1
-	-	N/A	N/A	N/A	N/A	N/A	-	0	1	1
-	-	N/A	N/A	N/A	N/A	-	N/A	13	31	44
-	-	N/A	-	+	-	-	-	19	16	35
-	-	N/A	-	+	-	-	-	15	17	32
-	-	N/A	-	-	+	-	-	15	22	37
-	-	N/A	-	-	-	+	-	8	9	17
-	-	N/A	-	-	-	-	+	4	8	12
-	-	N/A	+	-	-	N/A	-	1	0	1
-	-	N/A	+	-	-	-	N/A	14	7	21
-	-	N/A	-	+	-	N/A	-	1	0	1
-	-	N/A	-	+	-	-	N/A	3	7	10
-	-	N/A	N/A	-	+	-	-	0	1	1

Table 28. TV Analysis Per Patient Infected Status- INFECTED FEMALE Subjects (Urogenital)

E = Endocervical Swab, VS = Vaginal Swab, CCV = Clinician-Collected Vaginal Swab, SCV = Self Collected Vaginal Swab, FU =
Female Urine, N/A = Not Available

53

Table 29. TV Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

54

-	N/A	-	N/A	+	-	-	1	0	1
-	N/A	-	-	+	-	N/A	3	3	6
-	N/A	-	N/A	+	-	-	0	1	1
-	N/A	-	-	+	N/A	N/A	1	0	1
-	N/A	N/A	+	-	-	N/A	1	0	1
-	N/A	N/A	-	+	-	N/A	1	0	1
-	N/A	-	+	+	-	-	1	0	1
-	N/A	-	+	-	+	-	4	6	10
-	N/A	-	+	+	-	-	0	3	3
-	N/A	-	-	+	-	+	1	0	1
-	N/A	-	+	-	+	N/A	1	1	2
-	N/A	-	-	+	N/A	-	0	1	1
-	N/A	-	+	+	N/A	-	1	0	1
-	N/A	-	+	+	+	-	2	2	4
-	N/A	-	+	-	+	+	0	1	1

E = Endocervical Swab, VS = Vaginal Swab, CCV = Clinician-Collected Vaginal Swab,
SCV = Self Collected Vaginal Swab, FU = Female Urine, N/A = Not Available

55

NAAT 1	NAAT 2	NAAT 3	Alinity m STI				Number of Subjects
E	VS	VS	E	SCV	CCV	FU	PreservCyt	Symptomatic	Asymptomatic	Total
-	-	N/A	-	+	+	+	-	0	1	1
-	-	N/A	+	+	+	-	N/A	1	2	3
-	-	N/A	+	+	+	+	-	1	0	1
N/A	-	-	-	-	-	-	N/A	1	1	2
N/A	-	-	N/A	-	-	-	N/A	5	9	14
N/A	-	-	N/A	-	-	-	-	6	7	13
N/A	-	-	-	N/A	-	-	-	1	1	2
N/A	-	-	N/A	N/A	-	-	N/A	0	1	1
N/A	-	-	N/A	-	N/A	-	-	1	2	3
-	N/A	-	-	-	-	-	-	6	21	27
-	N/A	-	N/A	-	N/A	-	N/A	1	0	1
-	N/A	-	-	-	-	-	N/A	5	9	14
N/A	-	-	-	-	-	-	-	27	19	46
-	N/A	-	+	-	-	-	-	0	1	1
-	N/A	-	-	-	+	-	-	2	0	2
-	N/A	-	-	-	-	+	-	2	0	2
+	-	-	-	-	-	-	-	2	1	3
+	-	-	+	-	-	-	-	0	1	1
+	-	-	-	-	+	-	-	1	0	1
-	+	-	-	-	-	-	-	2	5	7
-	+	-	-	-	-	-	N/A	1	0	1
-	+	-	-	+	-	-	-	1	0	1
-	+	-	-	-	+	-	-	0	1	1
-	+	-	+	-	-	-	N/A	1	1	2
-	+	-	+	-	+	-	-	1	0	1
-	+	-	-	+	-	+	-	0	2	2

Table 29 Continued. TV Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

E = Endocervical Swab, VS = Vaginal Swab, CCV = Clinician-Collected Vaginal Swab,
SCV = Self Collected Vaginal Swab, FU = Female Urine

SCV = Self Collected Vaginal Swab, FU = Female Urine

56

Culture	NAAT 1	NAAT 2	Alinity m STI	Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
+	+	+	+	15	32	47
N/A	+	+	+	1	1	2
+	+	N/A	+	0	1	1
-	+	+	+	6	18	24
+	-	+	+	1	0	1
+	+	-	+	0	1	1
+	-	-	+	1	1	2
-	+	+	-	0	1	1

V Analysis Per Patient Intected Status- INFECTED MALE Subjects

MU = Male Urine, N/A = Not Available

Culture	NAAT 1	NAAT 2	Alinity m STI	Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
-	-	-	-	1047	2211	3258
N/A	-	-	-	17	59	76
-	N/A	-	-	5	19	24
-	-	N/A	-	6	22	28
-	+	-	-	1	0	1
-	-	+	-	0	2	2
-	-	-	+	6	15	21
-	N/A	-	+	1	0	1
-	-	+	+	2	2	4

MU = Male Urine, N/A = Not Available

57

NAAT 1	NAAT 2	NAAT 3		Alinity m STI				No. of Subjects
VS	VS	VS	E	SCV	CCV	Symptomatic	Asymptomatic	Total
+	+	N/A	+	+	+	75	58	133
+	+	N/A	N/A	+	+	2	2	4
+	+	N/A	+	N/A	+	0	1	1
+	+	N/A	+	+	N/A	1	0	1
+	+	N/A	+	+	+	6	11	17
+	+	N/A	+	-	+	3	2	5
+	+	N/A	+	+	N/A	1	0	1
N/A	+	+	+	+	+	8	3	11
N/A	+	+	-	+	+	0	1	1
+	N/A	+	+	+	+	1	0	1
+	N/A	+	N/A	+	N/A	0	1	1
+	-	+	+	+	+	34	14	48
+	-	+	N/A	+	+	3	2	5
+	-	+	+	N/A	+	1	0	1
+	-	+	N/A	+	N/A	0	1	1
+	-	+	-	+	+	12	9	21
+	-	+	+	-	+	1	2	3
+	-	+	+	+	-	1	1	2
+	-	+	-	-	+	2	0	2
+	-	+	-	+	-	0	1	1
+	-	+	+	-	-	0	1	1
+	-	+	N/A	-	-	0	1	1

Table 32. MG Analysis Per Patient Infected Status- INFECTED FEMALE Subjects (Urogenital)

VS = Vaginal Swab, CCV = Clinician-Collected Vaginal Swab, SCV = Self-Collected Vaginal Swab, NA = Not Available

58

NAAT 1	NAAT 2	NAAT 3	Alinity m STI			No. of Subjects
VS	VS	VS	E	SCV	CCV	Symptomatic	Asymptomatic	Total
-	-	N/A	-	-	-	1135	1281	2416
-	-	N/A	N/A	-	-	20	46	66
-	-	N/A	-	N/A	-	8	22	30
-	-	N/A	-	-	N/A	2	7	9
-	-	N/A	N/A	N/A	-	0	1	1
-	-	N/A	N/A	-	N/A	5	4	9
-	-	N/A	-	N/A	N/A	2	0	2
-	-	N/A	+	-	-	2	2	4
-	-	N/A	-	+	-	7	1	8
-	-	N/A	-	-	+	1	1	2
-	-	N/A	+	+	-	0	2	2
-	-	N/A	-	+	+	0	2	2
N/A	-	-	-	-	-	142	111	253
N/A	-	-	N/A	-	-	2	2	4
N/A	-	-	-	N/A	-	2	1	3
N/A	-	-	-	-	N/A	1	0	1
N/A	-	-	-	-	+	1	0	1
N/A	-	-	+	-	+	1	0	1
N/A	-	-	-	+	+	1	0	1
-	N/A	-	-	-	-	13	16	29
-	N/A	-	N/A	-	-	3	10	13
-	N/A	-	-	N/A	-	0	1	1
-	N/A	-	N/A	-	N/A	3	2	5
+	-	-	-	-	-	5	11	16
+	-	-	N/A	-	-	0	1	1
+	-	-	-	-	N/A	1	0	1
+	-	-	+	-	-	2	3	5
+	-	-	-	+	-	4	6	10
+	-	-	-	-	+	2	1	3
+	-	-	N/A	-	+	0	1	1
+	-	-	+	+	-	2	6	8
NAAT 1	NAAT 2	NAAT 3	Alinity m STI			No. of Subjects
VS	VS	VS	E	SCV	CCV	Symptomatic	Asymptomatic	Total
+	-	-	+	-	+	2	0	2
+	-	-	-	+	+	6	2	8
+	-	-	+	+	+	1	1	2
-	+	-	-	-	-	0	3	3
-	-	-	-	-	-	3	0	3

Table 33. MG Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

59

Table 33. MG Analysis Per Patient Infected Status- NOT INFECTED FEMALE Subjects (Urogenital)

VS = Vaginal Swab, CCV = Clinician-Collected Vaginal Swab, SCV = Self-Collected Vaginal Swab, FU = Female Uine, N/A = Not Available

NAAT 1	NAAT 2	NAAT 3	Alinity m STI	Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
+	+	+	+	56	69	125
N/A	+	+	+	15	8	23
+	N/A	+	+	2	7	9
+	+	N/A	+	3	2	5
-	+	+	+	2	0	2
+	-	+	+	6	9	15
+	+	-	+	15	15	30
+	+	+	-	1	1	2
+	+	-	-	1	1	2

Table 34. MG Analysis Per Patient Infected Status-INFECTEDMALE Subjects (Urogenital)

MU = Male Urine, N/A = Not Available

60

NAAT 1	NAAT 2	NAAT 3	Alinity m STI	Number of Subjects
MU	MU	MU	MU	Symptomatic	Asymptomatic	Total
-	-	-	-	790	1792	2582
N/A	-	-	-	123	187	310
-	N/A	-	-	8	141	149
-	-	N/A	-	24	48	72
+	-	-	-	13	21	34
-	+	-	-	0	1	1
-	-	+	-	0	5	5
-	-	-	+	1	2	3
N/A	-	-	+	3	4	7
+	-	-	+	36	35	71

Table 35. MG Analysis Per Patient Infected Status- NOTINFECTED MALE Subjects (Urogenital)

MU = Male Urine, N/A = Not Available

Expected Values

The prevalence of CT,NG, TV, and MG in this study was dependent on several factors including age, gender, clinic type, presence of symptoms, and the method of testing. A summary of the positivity for CT,NG, TV, and MG, as determined by the Alinity m STI Assay for each specimen type, is presented by collection site and overall in Table 36 through Table 39.

61

% Positivity (Number Positive / Number Tested with Valid Results)							% Positivity (Number Positive / Number Tested with Valid Results)				Collection Site	E	SCV	CCV	FU	PreservCyt	MU
Collection Site	E	SCV	CCV	MU	Collection Site	E	SCV	CCV	PreservCyt	MU	01	12.2 (5/41)	12.2 (5/41)	15.4 (6/39)	12.2 (5/41)	11.1 (4/36)	7.0 (4/57)
01	2.4 (1/41)	2.4 (1/41)	5.1 (2/39)	15.3 (9/59)	01	0.0 (0/41)	2.4 (1/41)	2.6 (1/39)	0.0 (0/36)	20.3 (12/59)	02	21.8 (121/554)	16.8 (96/570)	17.8 (101/569)	12.9 (75/581)	14.9 (40/269)	3.1 (28/890)
02	4.0 (22/552)	4.6 (26/568)	4.2 (24/567)	4.7 (42/889)	02	0.9 (5/553)	1.1 (6/569)	0.9 (5/568)	0.4 (1/268)	0.4 (4/889)	03	14.2 (32/225)	14.4 (32/222)	14.2 (33/233)	13.7 (32/233)	14.3 (32/224)	2.3 (6/260)
03	2.7 (6/225)	4.1 (9/222)	4.3 (10/232)	3.5 (9/260)	03	0.9 (2/225)	0.9 (2/222)	0.9 (2/233)	0.9 (2/224)	0.4 (1/260)	04	15.0 (3/20)	15.0 (3/20)	15.0 (3/20)	15.0 (3/20)	15.0 (3/20)	2.6 (3/116)
04	21.1 (4/19)	15.8 (3/19)	21.1 (4/19)	17.2 (20/116)	04	0.0 (0/20)	5.0 (1/20)	0.0 (0/20)	0.0 (0/20)	8.6 (10/116)	05	8.4 (20/237)	7.5 (19/253)	9.6 (24/251)	7.9 (20/254)	6.0 (15/249)	1.3 (3/230)
05	7.2 (17/237)	7.1 (18/254)	7.2 (18/251)	3.9 (9/233)	05	0.4 (1/237)	0.0 (0/254)	0.0 (0/251)	0.0 (0/263)	0.9 (2/233)	06	25.0 (1/4)	0.0 (0/3)	0.0 (0/4)	25.0 (1/4)	0.0 (0/4)	0.0 (0/24)
06	0.0 (0/4)	0.0 (0/3)	0.0 (0/4)	0.0 (0/24)	06	0.0 (0/4)	0.0 (0/3)	0.0 (0/4)	0.0 (0/4)	0.0 (0/24)	07	15.4 (61/395)	16.0 (70/438)	16.6 (72/433)	11.8 (55/466)	15.2 (47/310)	4.1 (25/609)
07	3.5 (14/395)	3.4 (15/438)	3.2 (14/433)	3.6 (22/606)	07	0.3 (1/395)	0.5 (2/438)	0.7 (3/433)	0.0 (0/310)	1.0 (6/608)	08	16.5 (17/103)	19.2 (20/104)	22.3 (23/103)	16.7 (17/102)	16.2 (17/105)	8.9 (7/79)
08	2.9 (3/103)	2.9 (3/105)	2.9 (3/104)	15.2 (12/79)	08	3.9 (4/103)	2.9 (3/105)	2.9 (3/104)	2.9 (3/105)	13.9 (11/79)	09	8.4 (9/107)	10.3 (11/107)	10.3 (11/107)	7.7 (8/104)	7.3 (8/109)	0.0 (0/47)
09	6.6 (7/106)	7.5 (8/107)	6.6 (7/106)	4.3 (2/47)	09	0.0 (0/106)	0.0 (0/107)	0.0 (0/106)	0.9 (1/108)	0.0 (0/47)	10	6.7 (7/105)	7.6 (8/105)	10.6 (11/104)	6.6 (7/106)	6.6 (7/106)	0.0 (0/112)
10	4.8 (5/105)	3.8 (4/105)	4.8 (5/104)	12.7 (14/110)	10	3.8 (4/104)	6.7 (7/104)	5.8 (6/103)	3.8 (4/105)	3.6 (4/111)	11	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	6.3 (1/16)
11	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	6.3 (1/16)	11	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	0.0 (0/18)	0.0 (0/16)	12	10.4 (5/48)	10.4 (5/48)	10.4 (5/48)	8.3 (4/48)	10.4 (5/48)	5.4 (2/37)
12	4.2 (2/48)	4.2 (2/48)	4.2 (2/48)	5.6 (2/36)	12	2.1 (1/48)	0.0 (0/48)	0.0 (0/48)	0.0 (0/48)	8.3 (3/36)	13	13.5 (7/52)	13.7 (7/51)	11.5 (6/52)	13.2 (5/38)	13.6 (6/44)	0.0 (0/33)
13	7.7 (4/52)	9.8 (5/51)	7.7 (4/52)	18.8 (6/32)	13	0.0 (0/52)	0.0 (0/51)	0.0 (0/52)	0.0 (0/44)	6.3 (2/32)	14	5.0 (2/40)	5.1 (2/39)	7.5 (3/40)	5.1 (2/39)	5.0 (2/40)	0.0 (0/25)
14	0.0 (0/39)	2.6 (1/38)	0.0 (0/39)	8.0 (2/25)	14	2.5 (1/40)	2.6 (1/39)	2.5 (1/40)	2.5 (1/40)	0.0 (0/25)	15	16.2 (6/37)	10.8 (4/37)	10.8 (4/37)	5.4 (2/37)	5.4 (2/37)	4.4 (3/68)
15	8.1 (3/37)	10.8 (4/37)	8.1 (3/37)	14.7 (10/68)	15	2.7 (1/37)	5.4 (2/37)	5.4 (2/37)	5.4 (2/37)	4.4 (3/68)	16	0.0 (0/16)	0.0 (0/15)	0.0 (0/15)	0.0 (0/16)	0.0 (0/16)	0.0 (0/7)
16	11.8 (2/17)	12.5 (2/16)	12.5 (2/16)	16.7 (1/6)	16	0.0 (0/17)	0.0 (0/16)	0.0 (0/16)	0.0 (0/17)	0.0 (0/6)	17	9.3 (4/43)	11.6 (5/43)	11.6 (5/43)	9.3 (4/43)	9.8 (4/41)	4.2 (1/24)
17	0.0 (0/43)	0.0 (0/43)	0.0 (0/43)	8.3 (2/24)	17	0.0 (0/43)	0.0 (0/43)	0.0 (0/43)	0.0 (0/41)	8.3 (2/24)	18	0.0 (0/6)	0.0 (0/6)	0.0 (0/6)	0.0 (0/5)	0.0 (0/6)	0.0 (0/1)
18	0.0 (0/5)	0.0 (0/5)	0.0 (0/5)	0.0 (0/1)	18	0.0 (0/5)	0.0 (0/5)	0.0 (0/5)	0.0 (0/5)	0.0 (0/1)	19	10.0 (1/10)	10.0 (1/10)	11.1 (1/9)	11.1 (1/9)	10.0 (1/10)	7.7 (1/13)
19	11.1 (1/9)	11.1 (1/9)	12.5 (1/8)	7.7 (1/13)	19	0.0 (0/9)	0.0 (0/9)	0.0 (0/8)	0.0 (0/9)	15.4 (2/13)	20	-	-	-	-	-	0.0 (0/1)
20	-	-	-	0.0 (0/1)	20					0.0 (0/1)	21	1.5 (2/134)	3.8 (5/132)	2.2 (3/134)	3.0 (4/134)	1.5 (2/133)	0.0 (0/77)
21	7.5 (10/133)	9.9 (13/131)	9.8 (13/133)	14.3 (11/77)	21	2.2 (3/134)	1.5 (2/132)	1.5 (2/134)	1.5 (2/133)	3.9 (3/77)	22	2.9 (1/34)	2.9 (1/35)	0.0 (0/35)	0.0 (0/34)	0.0 (0/34)	0.0 (0/26)
22	5.9 (2/34)	5.7 (2/35)	8.6 (3/35)	19.2 (5/26)	22	0.0 (0/34)	0.0 (0/35)	0.0 (0/35)	0.0 (0/34)	0.0 (0/26)	23	4.2 (5/118)	4.2 (5/120)	4.1 (5/121)	5.8 (7/121)	5.8 (7/120)	0.0 (0/45)
23	7.6 (9/118)	9.2 (11/120)	10.7 (13/121)	4.4 (2/45)	23	3.4 (4/118)	3.3 (4/120)	3.3 (4/121)	3.3 (4/122)	6.7 (3/45)	24	5.4 (2/37)	5.6 (2/36)	8.3 (3/36)	5.6 (2/36)	5.4 (2/37)	8.2 (5/61)
24	5.3 (2/38)	5.4 (2/37)	8.1 (3/37)	8.2 (5/61)	24	0.0 (0/38)	2.7 (1/37)	2.7 (1/37)	0.0 (0/38)	0.0 (0/61)	25	0.0 (0/50)	2.0 (1/50)	0.0 (0/51)	2.2 (1/45)	0.0 (0/47)	0.0 (0/49)
25	12.0 (6/50)	12.0 (6/50)	15.7 (8/51)	4.1 (2/49)	25	0.0 (0/50)	0.0 (0/50)	0.0 (0/51)	0.0 (0/47)	0.0 (0/49)	26	6.9 (2/29)	6.9 (2/29)	6.9 (2/29)	7.1 (2/28)	7.4 (2/27)	0.0 (0/33)
26	10.3 (3/29)	6.9 (2/29)	10.3 (3/29)	18.2 (6/33)	26	6.9 (2/29)	6.9 (2/29)	6.9 (2/29)	7.4 (2/27)	15.2 (5/33)	27	7.1 (6/84)	4.7 (4/85)	4.7 (4/85)	4.8 (4/84)	4.8 (4/83)	1.8 (1/56)
27	6.0 (5/84)	4.7 (4/85)	4.7 (4/85)	7.3 (4/55)	27	1.2 (1/84)	2.4 (2/85)	2.4 (2/85)	1.2 (1/83)	1.8 (1/56)	28	10.2 (23/225)	7.4 (17/231)	9.5 (22/231)	7.8 (18/230)	8.3 (19/230)	1.4 (2/138)
28	12.9 (29/225)	13.4 (31/231)	13.4 (31/231)	14.7 (20/136)	28	2.7 (6/225)	2.6 (6/231)	2.6 (6/231)	2.6 (6/230)	7.2 (10/138)	29	3.4 (3/87)	3.4 (3/87)	4.7 (4/86)	3.5 (3/85)	2.3 (2/86)	0.8 (1/119)
29	9.2 (8/87)	9.2 (8/87)	8.1 (7/86)	16.8 (20/119)	29	1.1 (1/87)	1.1 (1/87)	1.2 (1/86)	1.2 (1/86)	8.4 (10/119)	30	21.5 (14/65)	23.4 (15/64)	20.3 (13/64)	20.0 (13/65)	20.0 (13/65)	3.4 (2/59)
30	20.0 (13/65)	25.0 (16/64)	21.9 (14/64)	25.4 (15/59)	30	3.1 (2/65)	3.1 (2/64)	4.7 (3/64)	3.1 (2/65)	6.8 (4/59)	31	26.8 (19/71)	25.7 (18/70)	27.8 (20/72)	25.0 (18/72)	23.9 (17/71)	8.5 (5/59)
31	14.1 (10/71)	12.9 (9/70)	12.5 (9/72)	18.6 (11/59)	31	2.8 (2/71)	1.4 (1/70)	1.4 (1/72)	0.0 (0/71)	5.1 (3/59)	32	11.8 (6/51)	14.0 (7/50)	12.0 (6/50)	10.0 (5/50)	9.8 (5/51)	5.9 (3/51)
32	9.8 (5/51)	10.0 (5/50)	10.0 (5/50)	19.6 (10/51)	32	0.0 (0/51)	2.0 (1/50)	0.0 (0/50)	0.0 (0/51)	2.0 (1/51)	33	10.6 (5/47)	12.8 (6/47)	10.6 (5/47)	10.6 (5/47)	12.8 (6/47)	1.4 (1/72)
33	27.7 (13/47)	29.8 (14/47)	29.8 (14/47)	26.4 (19/72)	33	6.4 (3/47)	8.5 (4/47)	6.4 (3/47)	6.4 (3/47)	6.9 (5/72)	All	12.6 (380/3003)	11.8 (374/3166)	12.5 (395/3172)	10.1 (323/3195)	10.0 (272/2723)	3.0 (104/3494)
All	6.7 (206/3087)	7.1 (225/3163)	7.1 (226/3166)	8.4 (294/3487)	All	1.4 (44/3090)	1.6 (51/3166)	1.5 (48/3170)	1.3 (35/2736)	3.1 (107/3493)

Table 36 Positivity of CT as Determined by the Alinity m STI Assay by Specimen Type and Clinical Site for Urogenital Specimens

E = Endocervical Swab, SCV = Self-Collected Vaginal Swab, CCV = Clinician-Collected Vaginal Swab, MU = Male Urine

62

Table 37 Positivity of NG as Determined by the Alinity m STI Assay by Specimen Type and Clinical Site for Urogenital Specimens

E = Endocervical Swab, SCV = Self-Collected Vaginal Swab, CCV = Clinician-Collected Vaginal Swab, MU = Male Urine

63

Table 38. Positivity of TV as Determined by the Alinity m STI Assay by Specimen Type and Clinical Site for Urogenital Specimens

E = Endocervical Swab, SCV = Self-Collected Vaginal Swab, CCV = Clinician-Collected Vaginal Swab, FU = Female Urine, MU = Male Urine

64

| Collection Site | % E | SCV | CCV |-----------------|------------ | 01 | 17.5 (7/40) | 02 | 6.5 (36/551) | 03 | 5.8 (13/224) | 04 | 15.0 (3/20) | 05 | 7.6 (18/236) | 06 | 0.0 (0/4) | 07 | 7.1 (28/392) | 08 | 5.8 (6/103) | 09 | 10.5 (11/105) | 10 | 8.7 (9/104) | 11 | 5.6 (1/18) | 12 | 4.2 (2/48) | 13 | 0.0 (0/52) | 14 | 7.9 (3/38) | 15 | 13.9 (5/36) | 16 | 5.9 (1/17) | 17 | 11.6 (5/43) | 18 | 0.0 (0/6) | 19 | 20.0 (2/10) | 20 | - | 21 | 7.5 (10/134) | 22 | 5.7 (2/35) | 23 | 6.8 (8/117) | 24 | 10.5 (4/38) | 25 | 0.0 (0/49) | 26 | 6.9 (2/29) | 27 | 16.7 (14/84) | 28 | 6.7 (15/224) | 29 | 4.6 (4/87) | 30 | 9.2 (6/65) | 31 | 10.0 (7/70) | 32 | 3.9 (2/51) | 33 | 15.2 (7/46) | All | 7.5 (231/3076) Positivity (Number Positive / Number Tested with Valid Results)
| MU |
------------------------------------------------------------|----------------|----------------|----------------|
| 22.5 (9/40) | 23.7 (9/38) | 29.3 (17/58) |
| 7.1 (40/567) | 7.8 (44/566) | 6.7 (60/890) |
| 5.4 (12/221) | 5.6 (13/231) | 4.6 (12/259) |
| 15.0 (3/20) | 15.0 (3/20) | 19.1 (22/115) |
| 9.1 (23/252) | 9.2 (23/251) | 4.3 (10/233) |
| 0.0 (0/3) | 0.0 (0/4) | 12.5 (3/24) |
| 7.4 (32/434) | 6.0 (26/430) | 5.1 (29/574) |
| 5.7 (6/105) | 6.7 (7/104) | 19.0 (15/79) |
| 14.3 (15/105) | 13.2 (14/106) | 10.4 (5/48) |
| 13.5 (14/104) | 11.7 (12/103) | 6.4 (7/110) |
| 11.1 (2/18) | 5.6 (1/18) | 25.0 (4/16) |
| 4.2 (2/48) | 4.2 (2/48) | 2.8 (1/36) |
| 3.9 (2/51) | 3.8 (2/52) | 12.1 (4/33) |
| 10.8 (4/37) | 10.5 (4/38) | 0.0 (0/22) |
| 16.7 (6/36) | 11.1 (4/36) | 20.6 (14/68) |
| 0.0 (0/16) | 6.3 (1/16) | 0.0 (0/5) |
| 16.3 (7/43) | 18.6 (8/43) | 25.0 (6/24) |
| 0.0 (0/6) | 0.0 (0/6) | 0.0 (0/1) |
| 30.0 (3/10) | 33.3 (3/9) | 30.8 (4/13) |
| - | - | 0.0 (0/1) |
| 9.1 (12/132) | 7.5 (10/134) | 5.2 (4/77) |
| 11.1 (4/36) | 8.3 (3/36) | 4.0 (1/25) |
| 8.4 (10/119) | 8.3 (10/120) | 8.9 (4/45) |
| 13.5 (5/37) | 10.8 (4/37) | 9.8 (6/61) |
| 0.0 (0/49) | 0.0 (0/50) | 6.1 (3/49) |
| 6.9 (2/29) | 6.9 (2/29) | 6.1 (2/33) |
| 20.0 (17/85) | 15.3 (13/85) | 9.1 (5/55) |
| 9.1 (21/230) | 9.1 (21/230) | 7.4 (10/135) |
| 6.9 (6/87) | 7.0 (6/86) | 7.6 (9/119) |
| 10.9 (7/64) | 12.5 (8/64) | 11.9 (7/59) |
| 15.9 (11/69) | 12.7 (9/71) | 8.5 (5/59) |
| 10.0 (5/50) | 12.0 (6/50) | 14.6 (7/48) |
| 19.6 (9/46) | 17.4 (8/46) | 19.2 (14/73) |
| 9.2 (289/3149) | 8.7 (276/3157) | 8.4 (290/3447) |

Table 39. Positivity of MG as Determined by the Alinity m STI Assay by Specimen Type and Clinical Site for Urogenital Specimens

E = Endocervical Swab, SCV = Self-Collected Vaginal Swab, CCV = Clinician-Collected Vaginal Swab, MU = Male Urine

65

Positive and Negative Predictive Values for Hypothetical Prevalence Rates

The Positive and Negative Predictive Values (PPV and NPV) were calculated using hypothetical prevalence rates and the Alinity m STI Assay sensitivity and specificity determined from the clinical study. Estimates of the PPV and NPV for the Alinity m STI Assay for urogenital specimens are presented in Table 40 through Table 43 for CT,NG, TV, and MG, respectively.

Table 40. CT Positive and Negative Predictive Value Using Hypothetical Prevalence for Urogenital Specimens
Specimen
Type	Category	0.5%	1.0%	2.0%	5.0%	10.0%	15.0%	20.0%	25.0%	30.0%
CCV	PPV (%)	36.9	54.0	70.3	85.9	92.8	95.3	96.7	97.5	98.0
	NPV (%)	100.0	100.0	100.0	99.9	99.8	99.7	99.5	99.3	99.2
SCV	PPV (%)	40.0	57.2	73.0	87.5	93.6	95.9	97.1	97.8	98.3
	NPV (%)	100.0	100.0	100.0	99.9	99.8	99.7	99.6	99.5	99.4
E	PPV (%)	43.2	60.5	75.6	88.9	94.4	96.4	97.4	98.1	98.5
	NPV (%)	100.0	99.9	99.9	99.7	99.4	99.0	98.6	98.2	97.7
MU	PPV (%)	49.4	66.3	79.9	91.1	95.6	97.2	98.0	98.5	98.8
	NPV (%)	100.0	100.0	99.9	99.9	99.7	99.5	99.3	99.1	98.8
NPV (%)	100.0	100.0	99.9	99.9	99.7	99.5	99.3	99.1	98.8

CCV = Clinician-Collected Vaginal Swab, SCV = Self-Collected Vaginal Swab, E = Endocervical Swab, MU = Male Urine

Table 41. NG Positive and Negative Value Using Hypothetical Prevalence for Urogenital Specimens
Specimen
Type	Category	0.5%	1.0%	2.0%	5.0%	10.0%	15.0%	20.0%	25.0%	30.0%
CCV	PPV (%)	69.2	81.9	90.1	95.9	98.0	98.7	99.1	99.3	99.5
	NPV (%)	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0
SCV	PPV (%)	61.1	75.9	86.4	94.3	97.2	98.2	98.7	99.0	99.3
	NPV (%)	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0
E	PPV (%)	66.9	80.3	89.2	95.5	97.8	98.6	99.0	99.3	99.4
	NPV (%)	100.0	99.9	99.8	99.6	99.2	98.7	98.2	97.6	96.9
PreservCyt	PPV (%)	92.8	96.3	98.1	99.3	99.6	99.8	99.8	99.9	99.9
	NPV (%)	100.0	99.9	99.9	99.7	99.4	99.0	98.6	98.2	97.7
MU	PPV (%)	77.3	87.3	93.3	97.3	98.7	99.2	99.4	99.6	99.7
	NPV (%)	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0

CCV = Clinician-Collected Vaginal Swab, SCV = Self-Collected Vaginal Swab, E = Endocervical Swab, MU = Male Urine

66

| Specimen

Type	Category	0.5%	1.0%	2.0%	5.0%	10.0%	15.0%	20.0%	25.0%	30.0%
CCV	PPV (%)	15.3	26.7	42.4	65.5	80.0	86.4	90.0	92.3	93.9
	NPV (%)	100.0	100.0	100.0	100.0	100.0	99.9	99.9	99.9	99.9
SCV	PPV (%)	18.7	31.6	48.3	70.6	83.5	89.0	92.0	93.8	95.1
	NPV (%)	100.0	100.0	100.0	100.0	99.9	99.9	99.8	99.8	99.7
E	PPV (%)	13.9	24.4	39.5	62.7	78.0	85.0	88.9	91.4	93.2
	NPV (%)	100.0	100.0	100.0	99.9	99.7	99.6	99.4	99.2	99.0
PreservCyt	PPV (%)	45.7	62.8	77.4	89.8	94.9	96.7	97.7	98.2	98.6
	NPV (%)	100.0	100.0	99.9	99.8	99.5	99.2	98.9	98.5	98.1
FU	PPV (%)	34.1	51.0	67.8	84.4	92.0	94.8	96.3	97.2	97.8
	NPV (%)	100.0	99.9	99.9	99.6	99.2	98.8	98.3	97.7	97.1
MU	PPV (%)	39.5	56.7	72.6	87.2	93.5	95.8	97.0	97.7	98.2
	NPV (%)	100.0	100.0	100.0	99.9	99.9	99.8	99.7	99.6	99.5

Table 42. TV Positive and Negative Value Using Hypothetical Prevalence for Urogenital Specimens

| Specimen

Type	Category	0.5%	1.0%	2.0%	5.0%	10.0%	15.0%	20.0%	25.0%	30.0%
CCV	PPV (%)	38.3	55.5	71.6	86.7	93.2	95.6	96.9	97.6	98.1
	NPV (%)	100.0	100.0	100.0	99.9	99.8	99.7	99.5	99.4	99.2
SCV	PPV (%)	25.2	40.4	57.8	78.0	88.2	92.2	94.4	95.7	96.6
	NPV (%)	100.0	100.0	99.9	99.8	99.5	99.2	98.8	98.5	98.0
E	PPV (%)	32.9	49.6	66.6	83.7	91.5	94.5	96.1	97.0	97.7
	NPV (%)	99.9	99.8	99.6	99.1	98.1	97.0	95.8	94.5	93.1
MU	PPV (%)	16.4	28.4	44.4	67.3	81.3	87.4	90.7	92.9	94.4
	NPV (%)	100.0	100.0	100.0	99.9	99.8	99.7	99.5	99.4	99.2

CCV = Clinician-Collected Vaginal Swab, SCV = Self-Collected Vaginal Swab, E = Endocervical Swab, MU = Male Urine

67

Clinical Study Results - Extragenital Specimens 5.7.2.2

Performance characteristics of the Alinity m STI Assay with extragenital specimens were established in a multicenter clinical study conducted in the United States. Archived specimens were previously collected with an IRB/IEC approved consent. A total of 2,373 male and female, asymptomatic and symptomatic subjects were enrolled. Three oropharyngeal and 3 rectal specimens were collected from each subject using a common collection device created specifically for the study.

Specimen testing methods included the Alinity m STI Assay and 3 commercially available CT/NG NAAT comparator assays for each oropharyngeal and rectal specimen.

Comparator NAAT results were used to establish an anatomic site-specific composite comparator (CC). A specimen was categorized as infected for CT or NG if a minimum of 2 comparator positive results were reported and as not infected for CT or NG if a minimum of 2 comparator negative results was reported. Refer to Table 46 through Table 49 for the CC algorithm. If the specimen CC could not be determined for a given analyte (CT or NG) due to missing and/or indeterminate results from the comparator assays, the specimen was excluded from the analysis for that analyte. CC could not be determined for 6 oropharyngeal and 8 rectal specimens for CT, and 10 oropharyngeal and 6 rectal specimens for NG.

Alinity m STI CT and NG test results were compared to the CC for calculation of assay sensitivity and specificity. A total of 2,316 CT and 2,312 NG results from oropharyngeal specimens, and a total of 2,053 CT and 2,049 NG results from rectal specimens were used in the analysis. The results were analyzed by specimen type and the presence of symptoms. Sensitivity and specificity for CT for oropharyngeal and rectal specimens are presented in Table 44. Sensitivity and specificity for NG for oropharyngeal and rectal specimens are presented in Table 45.

68

Clinical Sensitivity and Specificity by Specimen Type and Symptom Status for pecimens

Specimen Type	Symptom Status	N	TP	FP	TN	FN	Sensitivity (%)		Specificity (%)
							Estimate
(95% CI)	n / N	Estimate
(95% CI)	n / N
Oropharyngeal	Symptomatic	741	8	0	733	0	100.0 (67.6,100.0)	8/8	100.0 (99.5,100.0)	733/733
Oropharyngeal	Asymptomatic	1575	20	2	1551	2	90.9 (72.2,97.5)	20/22	99.9 (99.5,100.0)	1551/1553
Oropharyngeal	All	2316	28	2	2284	2	93.3 (78.7, 98.2)	28/30	99.9 (99.7, 100.0)	2284/2286
Rectal	Symptomatic	668	55	2	610	1	98.2 (90.6,99.7)	55/56	99.7 (98.8,99.9)	610/612
Rectal	Asymptomatic	1385	83	6	1289	7	92.2 (84.8,96.2)	83/90	99.5 (99.0,99.8)	1289/1295
Rectal	All	2053	138	8	1899	8	94.5 (89.6, 97.2)	138/146	99.6 (99.2, 99.8)	1899/1907

Table 45 NG Clinical Sensitivity and Specificity by Specimen Type and Symptom Status for Extragenital Specimens

							Sensitivity (%)		Specificity (%)
							Estimate
(95% CI)	n / N	Estimate
(95% CI)	n / N
Specimen Type	Symptom Status	N	TP	FP	TN	FN
Oropharyngeal	Symptomatic	738	53	6	676	3	94.6 (85.4,98.2)	53/56	99.1 (98.1,99.6)	676/682
	Asymptomatic	1574	47	9	1516	2	95.9 (86.3,98.9)	47/49	99.4 (98.9,99.7)	1516/1525
	All	2312	100	15	2192	5	95.2 (89.3,98.2)	100/105	99.3 (98.9,99.6)	2192/2207
Rectal	Symptomatic	670	46	7	615	2	95.8 (86.0,98.8)	46/48	98.9 (97.7,99.5)	615/622
	Asymptomatic	1379	56	3	1319	1	98.2 (90.7,99.7)	56/57	99.8 (99.3,99.9)	1319/1322
	All	2049	102	10	1934	3	97.1 (91.9,99.0)	102/105	99.5 (99.1, 99.7)	1934/1944

69

A comparison of CC, individual test results from the comparator assays and Alinity m STI Assay was performed. CT results for infected and non-infected oropharyngeal specimens are presented in Table 46, and for infected and non-infected rectal specimens in Table 47. NG results for infected and non-infected oropharyngeal specimens are presented in

| CC | NAAT
1 | NAAT
2 | NAAT 3 | Alinity m
STI | Symptomatic | Asymptomatic | Total |
|--------------|-----------|-----------|--------|------------------|-------------|--------------|-------|
| Infected | + | + | + | + | 8 | 17 | 25 |
| | N/A | + | + | + | 0 | 1 | 1 |
| | - | + | + | + | 0 | 2 | 2 |
| | + | + | + | - | 0 | 1 | 1 |
| | - | + | + | - | 0 | 1 | 1 |
| Not Infected | - | - | - | - | 697 | 1510 | 2207 |
| | N/A | - | - | - | 1 | 0 | 1 |
| | - | N/A | - | - | 12 | 16 | 28 |
| | - | - | N/A | - | 7 | 6 | 13 |
| | + | - | - | - | 13 | 18 | 31 |
| | - | + | - | - | 1 | 1 | 2 |
| | - | - | + | - | 2 | 0 | 2 |
| | - | - | - | + | 0 | 1 | 1 |
| | - | + | - | + | 0 | 1 | 1 |

Table 48, and for infected and non-infected rectal specimens in Table 49.

70


CC	NAAT
1	NAAT
2	NAAT 3	Alinity m
STI		Symptomatic	Asymptomatic	Total
Infected	+	+	+	+	50	79	129
	N/A	+	+	+	1	0	1
	+	N/A	+	+	1	0	1
	-	+	+	+	1	1	2
	+	-	+	+	0	1	1
	+	+	-	+	2	2	4
	+	+	+	-	0	2	2
	-	+	+	-	1	0	1
	+	-	+	-	0	4	4
	+	+	-	-	0	1	1
Not Infected	-	-	-	-	580	1261	1841
	N/A	-	-	-	0	1	1
	-	N/A	-	-	13	8	21
	-	-	N/A	-	8	6	14
	+	-	-	-	4	9	13
	-	+	-	-	1	4	5
	-	-	+	-	4	0	4
	-	-	-	+	2	1	3
	+	-	-	+	0	2	2
	-	+	-	+	0	1	1
	-	-	+	+	0	2	2

71

					Number of Subjects
CC	NAAT 1	NAAT 2	NAAT 3	Alinity m STI	Symptomatic	Asymptomatic	Total
Infected	+	+	+	+	49	37	86
	N/A	+	+	+	1	0	1
	+	N/A	+	+	0	3	3
	-	+	+	+	0	2	2
	+	-	+	+	3	5	8
	+	+	+	-	1	1	2
	+	-	+	-	2	1	3
Not Infected	-	-	-	-	645	1476	2121
	N/A	-	-	-	2	0	2
	-	N/A	-	-	11	12	23
	-	-	N/A	-	6	6	12
	+	-	-	-	2	2	4
	-	+	-	-	5	12	17
	-	-	+	-	5	8	13
	-	-	-	+	3	4	7
	-	N/A	-	+	0	1	1
	+	-	-	+	2	1	3
	-	+	-	+	1	3	4

Table 48. NG Analysis per Composite Comparator – Oropharyngeal Specimens

72

					Number of Subjects
CC	NAAT 1	NAAT 2	NAAT 3	Alinity m STI	Symptomatic	Asymptomatic	Total
Infected	+	+	+	+	41	53	94
	+	N/A	+	+	0	2	2
	+	-	+	+	4	1	5
	+	+	-	+	1	0	1
	+	-	+	-	2	1	3
Not Infected	-	-	-	-	587	1303	1890
	-	N/A	-	-	14	7	21
	-	-	N/A	-	8	6	14
	+	-	-	-	3	0	3
	-	+	-	-	0	2	2
	-	-	+	-	3	1	4
	-	-	-	+	3	2	5
	+	-	-	+	2	0	2
	-	-	+	+	2	1	3

Table 49. NG Analysis per Composite Comparator – Rectal Specimens

73

Expected Values

The prevalence of CT and NG in this study was dependent on several factors including age, gender, clinic type, presence of symptoms, and the method of testing. A summary of the positivity of CT and NG detection, as determined by the Alinity m STI Assay, is presented by collection site and overall in Table 50.

| | | % Positivity
(Number Positive / Number Tested with Valid Results) for CT | | % Positivity
(Number Positive / Number Tested with Valid Results) for NG | |
|--------------------|--|-----------------------------------------------------------------------------|----------------|-----------------------------------------------------------------------------|---------------|
| Collection
Site | | Oropharyngeal | Rectal | Oropharyngeal | Rectal |
| 01 | | 1.2 (2/170) | 4.0 (6/149) | 2.9 (5/170) | 2.0 (3/149) |
| 02 | | 1.1 (1/91) | 3.4 (3/87) | 5.6 (5/90) | 3.4 (3/87) |
| 03 | | 1.0 (4/385) | 14.1 (46/326) | 12.6 (48/382) | 15.4 (50/324) |
| 04 | | 0.6 (1/168) | 2.9 (4/140) | 0.6 (1/168) | 2.9 (4/138) |
| 05 | | 0.9 (2/227) | 6.6 (14/212) | 7.9 (18/227) | 7.0 (15/213) |
| 06 | | 2.4 (10/413) | 9.6 (34/355) | 3.1 (13/413) | 4.2 (15/354) |
| 07 | | 1.8 (7/396) | 4.6 (18/393) | 2.5 (10/396) | 2.0 (8/394) |
| 08 | | 0.6 (3/466) | 5.4 (21/391) | 3.2 (15/466) | 3.6 (14/390) |
| All | | 1.3 (30/2332) | 7.1 (146/2053) | 5.0 (115/2312) | 5.5(112/2049) |

74

Positive and Negative Predictive Values for Hypothetical Prevalence Rates

The Positive and Negative Predictive Values (PPV and NPV) were calculated using hypothetical prevalence rates and the Alinity m STI Assay sensitivity and specificity determined from the clinical study. Estimates of the PPV and NPV for the Alinity m STI Assay for extragenital specimens are presented in Table 51 and Table 52 for CT and NG, respectively.

Table 51. CT Positive and Negative Predictive Value Using Hypothetical Prevalence for Extragenital Specimens
Specimen Type	Category	0.5%	1.0%	2.0%	5.0%	10.0%	15.0%	20.0%	25.0%	30.0%
Oropharyngeal	PPV (%)	84.3	91.5	95.6	98.3	99.2	99.5	99.6	99.7	99.8
	NPV (%)	100.0	99.9	99.9	99.7	99.3	98.8	98.4	97.8	97.2
Rectal	PPV (%)	53.1	69.5	82.1	92.2	96.2	97.5	98.3	98.7	99.0
	NPV (%)	100.0	99.9	99.9	99.7	99.4	99.0	98.6	98.2	97.7

Table 52. NG Positive and Negative Predictive Value Using Hypothetical Prevalence for Extragenital Specimens
Specimen Type	Category	0.5%	1.0%	2.0%	5.0%	10.0%	15.0%	20.0%	25.0%	30.0%
Oropharyngeal	PPV (%)	41.3	58.6	74.1	88.1	94.0	96.1	97.2	97.9	98.4
Oropharyngeal	NPV (%)	100.0	100.0	99.9	99.7	99.5	99.2	98.8	98.4	98.0
Rectal	PPV (%)	48.7	65.6	79.4	90.9	95.5	97.1	97.9	98.4	98.8
Rectal	NPV (%)	100.0	100.0	99.9	99.8	99.7	99.5	99.3	99.1	98.8

75

5.8 Conclusions Drawn from the Studies

The analytical and clinical study results demonstrate that the Alinity m STI Assay on the Alinity m System performs comparably to the predicate devices in detecting Chlamydia trachomatis, Neisseria gonorrhea, Trichomonas vaginalis, and Mycoplasma genitalium microorganisms that cause sexually transmitted infections and support a substantial equivalence decision.

-	N/A	-	N/A	+	-	-	1	0	1
-	N/A	-	-	+	-	N/A	3	3	6
-	N/A	-	N/A	+	-	-	0	1	1
-	N/A	-	-	+	N/A	N/A	1	0	1
-	N/A	N/A	+	-	-	N/A	1	0	1
-	N/A	N/A	-	+	-	N/A	1	0	1
-	N/A	-	+	+	-	-	1	0	1
-	N/A	-	+	-	+	-	4	6	10
-	N/A	-	+	+	-	-	0	3	3
-	N/A	-	-	+	-	+	1	0	1
-	N/A	-	+	-	+	N/A	1	1	2
-	N/A	-	-	+	N/A	-	0	1	1
-	N/A	-	+	+	N/A	-	1	0	1
-	N/A	-	+	+	+	-	2	2	4
-	N/A	-	+	-	+	+	0	1	1

-	N/A	-	N/A	+	-	-	1	0	1
-	N/A	-	-	+	-	N/A	3	3	6
-	N/A	-	N/A	+	-	-	0	1	1
-	N/A	-	-	+	N/A	N/A	1	0	1
-	N/A	N/A	+	-	-	N/A	1	0	1
-	N/A	N/A	-	+	-	N/A	1	0	1
-	N/A	-	+	+	-	-	1	0	1
-	N/A	-	+	-	+	-	4	6	10
-	N/A	-	+	+	-	-	0	3	3
-	N/A	-	-	+	-	+	1	0	1
-	N/A	-	+	-	+	N/A	1	1	2
-	N/A	-	-	+	N/A	-	0	1	1
-	N/A	-	+	+	N/A	-	1	0	1
-	N/A	-	+	+	+	-	2	2	4
-	N/A	-	+	-	+	+	0	1	1

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Section 5: 510(k) Summary

Table of Contents

5.0 510(k) Summary

Submitter 5.1

5.2 Device Information

5.3 Predicate Devices

5.4 Device Description

5.5 Intended Use

Alinity m STI AMP Kit:

Alinity m multi-Collect Specimen Collection Kit:

5.6 Similarities and Differences to Predicate Devices

5.7 Performance Data

Specific Performance Characteristics 5.7.1

5.7.1.1 Analytical Sensitivity

Urogenital Specimens

Extragenital Specimens

5.7.1.2 Inclusivity

5.7.1.3 Evaluation of Potential Cross Reacting Microorganisms

Urogenital Specimens

Table 2. Urogenital Microorganisms

Extragenital Specimens

5.7.1.4 Evaluation of Potential Interfering Substances

Urogenital Specimens

Extragenital Specimens

Competitive Interference Study 5.7.1.5

Within Laboratory Precision 5.7.1.6

Table 7. Within Lab Precision: CT Results

Table 8. Within Lab Precision: NG Results

Table 9. Within Lab Precision: TV Results

Table 10. Within Lab Precision: MG Results

5.7.1.7 Carryover

Reproducibility Study 5.7.1.8

Table 12 Reproducibility Analysis: NG Results

Table 12 Reproducibility Analysis: NG Results

Table 13. Reproducibility Analysis: TV Results

Table 14. Reproducibility Analysis: MG Results

5.7.2 Clinical Performance

Clinical Study Results - Urogenital Specimens 5.7.2.1

Table 15. CT Clinical Sensitivity and Specificity by Gender, Specimen Type and Symptom Status for Urogenital Specimens

Expected Values

Positive and Negative Predictive Values for Hypothetical Prevalence Rates

Clinical Study Results - Extragenital Specimens 5.7.2.2

Clinical Sensitivity and Specificity by Specimen Type and Symptom Status for pecimens

Table 49. NG Analysis per Composite Comparator – Rectal Specimens

Expected Values

Positive and Negative Predictive Values for Hypothetical Prevalence Rates

5.8 Conclusions Drawn from the Studies

-	N/A	-	N/A	+	-	-	1	0	1
-	N/A	-	-	+	-	N/A	3	3	6
-	N/A	-	N/A	+	-	-	0	1	1
-	N/A	-	-	+	N/A	N/A	1	0	1
-	N/A	N/A	+	-	-	N/A	1	0	1
-	N/A	N/A	-	+	-	N/A	1	0	1
-	N/A	-	+	+	-	-	1	0	1
-	N/A	-	+	-	+	-	4	6	10
-	N/A	-	+	+	-	-	0	3	3
-	N/A	-	-	+	-	+	1	0	1
-	N/A	-	+	-	+	N/A	1	1	2
-	N/A	-	-	+	N/A	-	0	1	1
-	N/A	-	+	+	N/A	-	1	0	1
-	N/A	-	+	+	+	-	2	2	4
-	N/A	-	+	-	+	+	0	1	1