BD MAX CTGCTV2, BD MAX System

• K Number: K182692
• Device Name: BD MAX CTGCTV2, BD MAX System
• Manufacturer: Becton, Dickinson and Company
• Date Cleared: 2019-01-08 ( 103 days)
• Product Code: OUY , LSL , MKZ
• Regulation Number: 866.3860
• Type: Traditional
• Panel: Microbiology
• Reference & Predicate Devices: K151589
• Predicate For: K193081 , K210585

Intended Use

The BD MAX™ CTGCTV2 assay, performed on 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) ●
• Trichomonas vaginalis (TV) ●

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

Device Description

The BD MAX System and the BD MAX CTGCTV2 are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. A test result may be called as POS, NEG, UNR, IND or INC for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System level failure.

AI/ML Overview

The provided information describes the BD MAX CTGCTV2 assay, a diagnostic device for detecting Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV).

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established for diagnostic assays in terms of sensitivity (Positive Percent Agreement - PPA) and specificity (Negative Percent Agreement - NPA). The presented clinical performance results in Table 21 for CT and GC, and Table 22 for TV, serve as the reported device performance against these criteria.

Specimen Type (Female)	Organism	Acceptance Criteria (Implicit from context, typical for diagnostic NAATs)	Reported Device Performance (PPA / Sensitivity)	Reported Device Performance (NPA / Specificity)
Vaginal (Clinician)	C. trachomatis	High sensitivity & specificity (typically >90% sensitivity, >98% specificity)	98.4% (126/128)	98.9% (2,348/2,374)
Vaginal (Clinician)	N. gonorrhoeae	High sensitivity & specificity	97.7% (42/43)	99.9% (2,457/2,460)
Vaginal (Clinician)	T. vaginalis	High sensitivity & specificity	97.8% (182/186)	99.6% (1,540/1,546)
Vaginal (Patient)	C. trachomatis	High sensitivity & specificity	98.4% (126/128)	98.7% (2,348/2,380)
Vaginal (Patient)	N. gonorrhoeae	High sensitivity & specificity	100% (43/43)	99.8% (2,459/2,463)
Vaginal (Patient)	T. vaginalis	High sensitivity & specificity	97.9% (185/189)	99.2% (1,540/1,553)
Endocervical	C. trachomatis	High sensitivity & specificity	94.5% (121/128)	99.2% (2,366/2,384)
Endocervical	N. gonorrhoeae	High sensitivity & specificity	95.3% (41/43)	100% (2,467/2,468)
LBC PreservCyt	C. trachomatis	High sensitivity & specificity	92.7% (115/124)	99.8% (2,340/2,345)
LBC PreservCyt	N. gonorrhoeae	High sensitivity & specificity	92.9% (39/42)	100% (2,427/2,428)
Urine (Female)	C. trachomatis	High sensitivity & specificity	98.4% (121/123)	99.3% (2,278/2,293)
Urine (Female)	N. gonorrhoeae	High sensitivity & specificity	100% (39/39)	100% (2,379/2,380)
Urine (Female)	T. vaginalis	High sensitivity & specificity	100% (173/173)	99.6% (1,467/1,473)
Urine (Male)	C. trachomatis	High sensitivity & specificity	96.7% (148/153)	99.4% (981/987)
Urine (Male)	N. gonorrhoeae	High sensitivity & specificity	99.2% (122/123)	99.9% (1,018/1,019)
Urine (Male)	T. vaginalis	High sensitivity & specificity	97.9% (47/48)	99.7% (1,090/1,093)

2. Sample Size Used for the Test Set and Data Provenance

The clinical performance study included 2,547 female subjects and 1,159 male subjects from North America.
The study was prospective, as indicated by the enrollment of subjects and collection of specimens for the trial.
The data provenance is North America, specifically from "Twelve geographically diverse clinical sites."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the "number of experts" used to establish ground truth or their individual qualifications (e.g., radiologist with 10 years of experience). Instead, the ground truth was established using an algorithmic approach with multiple FDA-cleared NAATs (Nucleic Acid Amplification Tests). This is a common and accepted method for determining the true infection status in diagnostic studies for infectious diseases, rather than relying on individual expert interpretation.

4. Adjudication Method for the Test Set

The adjudication method for establishing the Patient Infected Status (PIS) was as follows:

• Female PIS for C. trachomatis and N. gonorrhoeae: Established by testing urine and cervical specimens with two different FDA cleared NAATs. Females were designated as infected if at least two different reference NAATs were positive for urine and cervical specimens. For swab specimens, if only urine was positive with two comparator NAATs (and swabs were negative with both), they were considered non-infected.
• Male PIS for C. trachomatis and N. gonorrhoeae: Established by testing urine specimens using up to three different FDA cleared NAATs. Males were designated as infected if 2 out of 3 reference NAAT results were positive. They were categorized as non-infected if 2 out of 3 reference NAAT results were negative.
• Female PIS for T. vaginalis: Established by testing vaginal specimens with two different FDA cleared molecular tests, across three different instrument platforms. Females were designated as infected if 2 out of 3 reference test results were positive. They were categorized as non-infected if 2 out of 3 reference test results were negative.
• Male PIS for T. vaginalis: Established by testing urine specimens using up to three different FDA cleared NAATs. Males were designated as infected if 2 out of 3 reference test results were positive. They were categorized as non-infected if 2 out of 3 reference test results were negative.
• Female Urine CCA for C. trachomatis, N. gonorrhoeae, and T. vaginalis: Urine samples were used from up to three reference NAATs. Designated as positive if 2 out of 3 reference NAAT results were positive, and negative if 2 out of 3 reference NAAT results were negative.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is more common for image-based diagnostic aids where human interpretation is a primary component, and the AI assists human readers. For an automated molecular diagnostic assay like the BD MAX CTGCTV2, the device's performance is standalone.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily presents standalone performance of the BD MAX CTGCTV2 assay. The assay is an "automated DNA extraction and real-time polymerase chain reaction (PCR)" system, and its interpretation is done "automatically" by the BD MAX System software. The clinical performance tables (Table 21, 22, 23) reflect the algorithm-only performance against the established PIS.

7. Type of Ground Truth Used

The ground truth used was expert consensus derived through an algorithm based on multiple FDA-cleared Nucleic Acid Amplification Tests (NAATs). This is a common and robust method for establishing ground truth in molecular diagnostics, as these reference NAATs are highly sensitive and specific.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" sample size for the development of the BD MAX CTGCTV2 assay. This is typical for a 510(k) submission for an in vitro diagnostic (IVD) device, where the focus is on the validation of the finalized product's performance rather than the detailed development (training) process. The analytical studies (LoD, inclusivity, specificity) demonstrate the characteristics of the assay, which would have been refined during development.

9. How the Ground Truth for the Training Set Was Established

As no specific training set and its ground truth establishment are detailed, this information is not available in the provided text. The analytical studies like Limits of Detection (LoD), inclusivity, and analytical specificity use well-characterized microbial suspensions and established methods for their testing. These analytical studies are part of the broader validation, implying that the assay's design was based on such principles during its development.

Summary

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January 8, 2019

Becton, Dickinson and Company Katie Edwards Regulatory Affairs Project Manager 7 Loveton Circle Sparks, Maryland 21152

Re: K182692

Trade/Device Name: BD MAX CTGCTV2, BD MAX System Regulation Number: 21 CFR 866.3860 Regulation Name: Trichomonas vaginalis nucleic acid assay Regulatory Class: Class II Product Code: OUY, MKZ, LSL Dated: January 4, 2019 Received: January 7, 2019

Dear Katie Edwards:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Uwe Scherf -S

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K182692

Device Name BD MAX™ CTGCTV2

Indications for Use (Describe)

The BD MAX™ CTGCTV2 assay, performed on 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) ●
• Trichomonas vaginalis (TV) ●

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

Ancillary Collection kits:

The BD MAX 3-in-1 Swab Collection Kit is intended to be used in clinical settings according to the instructions provided for collection and transport of vaginal and endocervical swab specimens. This transport system is for use for testing with BD MAX products.

The BD MAX Urine Transport Kit is intended to be used in clinical settings according to the instructions provided for collection, preservation and transport of urine specimens. This transport system is for use for testing with the BD MAX products.

The BD MAX LBC Sample Buffer Tubes are intended to be used in clinical settings according to the instructions provided for the preservation and transport of Liquid-Based Cytology (LBC) specimens. This transport system is for use for testing with the BD MAX products.

Type of Use (Select one or both, as applicable)

区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The Counter Use (21 CFR 801 Subpart C)

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510(k) Summary BD MAX™ CTGCTV2

Summary Preparation Date:

12/28/2018

Submitted by:

BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Contact:

Katie Edwards Regulatory Affairs Project Manager Tel: [phone] Email: [e-mail]

Proprietary Names:

For the instrument: BD MAX™ System For the assay: BD MAX CTGCTV2

Common Names:

For the instrument: Bench-top molecular diagnostics workstation

For the assay: CT assay GC assay TV assay

Regulatory Information

Regulation section: 866.3860 – Trichomonas vaginalis Nucleic Acid Amplification Test System Classification: Class II

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Panel: Microbiology (83)

Product Code(s):

MKZ Chlamydia trachomatis

• LSL Neisseria gonorrhoeae
• OUY Trichomonas vaginalis

Predicate Device:

BD MAX™ CT/GC/TV [510(k) K151589]

Performance Standards:

Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis, August 4, 2015.

Intended Use:

The BD MAX™ CTGCTV2 assay, performed on 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)
• Trichomonas vaginalis (TV) ●

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

Special Conditions for Use Statement: For prescription use

Special Instrument Requirements: BD MAX System

Device Description:

The BD MAX System and the BD MAX CTGCTV2 are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. A test result may be called

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as POS, NEG, UNR, IND or INC for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System level failure.

Test Principle:

The BD MAX CTGCTV2 assay is designed for use with the applicable BD MAX specimen collection and transport devices, including the BD MAX™ Urine Transport Kit, the BD MAX™ LBC Sample Buffer Tubes or the BD MAX™ 3-in-1 Swab Collection Kit. The specimen is collected from the patient and transported to the testing laboratory using the appropriate transport device under conditions of time and temperature that have been determined to maintain the integrity of the target nucleic acids.

LBC samples are pre-warmed on the BD Pre-warm Heater hefore testing on the BD MAX System. None of the other specimen types undergo a pre-warm step. The Sample Buffer Tubes are recapped with a septum cap prior to processing on the BD MAX System. A worklist is created and the Sample Buffer Tube, the BD MAX CTGCTV2 Unitized Reagent Strip and the BD MAX PCR Cartridge are loaded onto the BD MAX System. The BD MAX System automates sample preparation, including target organism lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The BD MAX System performs results interpretation automatically. The assay also includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The Sample Processing Control monitors DNA extraction steps, thermal cycling steps, reagent integrity and presence of inhibitory substances.

Nucleic acids that are released from the target organisms as a result of cell lysis during the extraction process are captured on magnetic affinity beads. together with the bound nucleic acids, are washed using Wash Buffer and the nucleic acids are eluted by a combination of heat and pH. Eluted DNA is neutralized using Neutralization Buffer and transferred to the Master Mix to rehydrate the PCR reagents. After reconstitution, the BD MAX System dispenses a fixed volume of PCR-ready solution containing extracted nucleic acids into the BD MAX PCR Cartridge. Microvalves in the BD MAX PCR Cartridge are sealed by the system prior to initiating PCR in order to contain the amplification mixture, thus preventing evaporation and contamination.

The BD MAX CTGCTV2 assay is comprised of two targets for Chlamydia trachomatis (detected on the same optical channel), two targets for Neisseria gonorrhoeae (detected on two different optical channels) and one target for Trichomonas vaginalis (detected on one optical channel). Only one Chlamydia trachomatis target is required to be positive in order to report a positive result. Both Neisseria gonorrhoeae targets are required to be positive in order to report a positive result. The amplified DNA targets are detected using hydrolysis (TaqMan®) probes, labeled at one end with a fluorescent reporter dye (fluorophore), and at the other end, with a quencher moiety. Probes labeled with different fluorophores are used to detect amplicons for target analytes and the Sample Processing Control in five different optical channels of the BD MAX System. When the probes are in their native state, the fluorescence of the fluorophore is quenched due to its proximity to the quencher. However, in the presence of target DNA, the probes hybridize to their complementary sequences and are hydrolyzed by the 5 - 3' exonuclease activity of the DNA polymerase as it synthesizes the nascent strand along the DNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The BD MAX System monitors these signals at the end of each cycle and interprets the data at the end of the reaction to provide qualitative test results for each analyte (i.e., positive or negative).

Substantial Equivalence:

Table 1 provides the similarities and differences between the BD MAX CTGCTV2 and the predicate device.

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Items	BD MAX CTGCTV2	BD MAX CT/GC/TV
510(k)#	K182692	K151589
Regulation	866.3860	866.3860
Product Code	MKZ, LSL, OUY	MKZ, LSL, OUY
Device Class	II	II
Intended Use	The BD MAX CTGCTV2 assay, performed on 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)Trichomonas vaginalis (TV)The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.	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.
Indicationsfor Use	Asymptomatic and Symptomatic Patients	Asymptomatic and Symptomatic Patients
Specimen Type	Clinician-collected vaginal swab, patient-collected vaginal swab, endocervical swab, PreservCyt LBC, female and male urine	Endocervical swab, patient-collected vaginal swab, female and male urine
Technology	PCR	PCR
Organisms Detected	CT, GC and TV	CT, GC and TV
Sample Prep /Interpretation ofResults	Automated by BD MAX System	Automated by BD MAX System
Assay Controls	Sample Processing Control
	Target	Dye	Channel
Target Detection	CT	FAM	FAM
	CT	FAM	FAM
	GC (GC1)	CFO	VIC
	GC (GC2)	Q705	CY5.5
	TV	Q670	CY5
Collection/Transport Device	Swab Sample Buffer Tube (2.0 mL)Urine Sample Buffer Tube (0.5 mL)LBC Sample Buffer Tube (1.5 mL)	UVE Sample Buffer Tube (1.5 mL)
Sample Prep	1 swab added to Swab Sample Buffer Tube2.0 mL urine added to Urine Sample BufferTube	1 swab or 1.0 mL urine added to UVESample Buffer Tube

Table 1:	Comparison to Predicate Device
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0.5 mL LBC added to LBC Sample Buffer Tube
Prewarm	Pre-warm only LBC samples prior to extraction	Pre-warm all UVE samples prior to extraction
Extraction	Same	Magnetic affinity beads with protease
On-board lysis	On-board lysis of all specimens	No on-board lysis
Results Metric	Ct score	SDPA with minimum endpoint threshold
	Assay Result Reported	Interpretation of Result	Assay Result Reported	Interpretation of Result
	CT POS	Chlamydia trachomatis DNA Detected	CT POS	Chlamydia trachomatis DNA Detected
	CT NEG	No Chlamydia trachomatis DNA Detected	CT NEG	No Chlamydia trachomatis DNA Detected
ResultsInterpretation	CT UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification	CT UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification
	GC POSa	Neisseria gonorrhoeae DNA Detected	GC POS	Neisseria gonorrhoeae DNA Detected
	GC NEG	No Neisseria gonorrhoeae DNA Detected	GC NEG	No Neisseria gonorrhoeae DNA Detected
	GC UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification	GC UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification
	TV POS	Trichomonas vaginalis DNA Detected	TV POS	Trichomonas vaginalis DNA Detected
	TV NEG	No Trichomonas vaginalis DNA Detected	TV NEG	No Trichomonas vaginalis DNA Detected
	TV UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification	TV UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification
	IND	Indeterminate result due to BD MAX System failure (with Warning or Error Codes)	IND	Indeterminate result due to BD MAX System failure (with Warning or Error Codes)
	INC	Incomplete Run (with Warning or Error Codes)	INC	Incomplete Run (with Warning or Error Codes)

ª Detection of both GC1 and GC2 gene targets required to report a positive result.

Analytical Performance

Precision

Within-laboratory precision was evaluated for the BD MAX CTGCTV2 assay at one site with one reagent lot. Testing was performed over 12 days, with 2 runs per day (2 technologists, alternating operators each day), for a total of 24 runs. Test samples were contrived in female urine, in vaginal swab clinical matrix and in PreservCyt LBC specimen matrix and included Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis panel member was tested in two replicates.

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The following target concentrations were used for spiking levels of the target organisms contained in each panel member:

• Moderate Positive (MP): 3X LoD
• Low Positive (LP): 1.5X LoD
• . High Negative (HN): < 1X LoD
• True negative (TN): no target

Precision study results for the BD MAX CTGCTV2 are described in Table 2.

Category	Chlamydia trachomatis(n), 95% CI			Neisseria gonorrhoeae(n), 95% CI			Trichomonas vaginalis(n), 95% CI
	Swab	Urine	LBCc	Swab	Urine	LBCc	Swab	Urine
TNa	100%	100%	99.4%	100%	100%	100%	100%	100%
	(336/336)	(336/336)	(334/336)	(336/336)	(336/336)	(336/336)	(336/336)	(336/336)
	98.9-100	98.9-100	97.9-99.8	98.9-100	98.9-100	98.9-100	98.9-100	98.9-100
HNb	31.3%	31.3%	18.8%	27.1%	29.2%	16.7%	37.5%	68.8%
	(15/48)	(15/48)	(9/48)	(13/48)	(14/48)	(8/48)	(18/48)	(33/48)
	19.9-45.3	19.9-45.3	10.2-31.9	16.6-41.0	18.2-43.2	8.7-29.6	25.2-51.6	54.7-80.1
LP	100%	100%	100%	97.9%	100%	100%	97.9%	100%
	(48/48)	(48/48)	(48/48)	(47/48)	(48/48)	(48/48)	(47/48)	(48/48)
	92.6-100	92.6-100	92.6-100	89.1-99.6	92.6-100	92.6-100	89.1-99.6	92.6-100
MP	100%	100%	100%	100%	100%	100%	100%	100%
	(48/48)	(48/48)	(48/48)	(48/48)	(48/48)	(48/48)	(48/48)	(48/48)
	92.6-100	92.6-100	92.6-100	92.6-100	92.6-100	92.6-100	92.6-100	92.6-100

Table 2: Overall Precision Study Results (Percent Agreement with Expected Results)

a For the True Negative (TN) category, the reported agreement indicates the percent of negative results. b For the High Negative (HN) category, the reported agreement indicates the percent of positive results.

° PreservCyt LBC

Reproducibility

For the Site-to-Site reproducibility study, three sites (2 external and one internal) were provided the same panels as described for the Precision study, above. Each site performed testing on eight distinct days (consecutive or not), wherein each day, two panels were tested by two technologists (alternating operators each day).

All targets ranged from 99.6% to 100% for TN, 11.5% to 78.1% for HN, 97.9% to 100% for LP and 97.9% to 100% for MP categories (Table 3). Ct score, internal criterion used to determine a final assay result, was selected as an additional means of assessing assay reproducibility. Overall mean Ct score values with variance components (SD and %CV) are shown in Tables Table 4 through Table 6.

{10}------------------------------------------------

Category	Chlamydia trachomatis(n), 95% CI			Neisseria gonorrhoeae(n), 95% CI			Trichomonas vaginalis(n), 95% CI
	Swab	Urine	LBCc	Swab	Urine	LBCc	Swab	Urine
	TNa	99.6%(669/672)98.7-99.8	100%(672/672)99.4-100	100%(672/672)99.4-100	100%(672/672)99.4-100	100%(672/672)99.4-100	99.9%(671/672)99.2-100	99.9%(671/672)99.2-100
HNb	20.8%(20/96)13.9-30.0	35.4%(34/96)26.6-45.4	21.9%(21/96)14.8-31.1	34.4%(33/96)25.6-44.3	28.1%(27/96)20.1-37.8	11.5%(11/96)6.5-19.4	37.5%(36/96)28.5-47.5	78.1%(75/96)68.9-85.2
LP	100%(96/96)96.2-100	100%(96/96)96.2-100	100%(96/96)96.2-100	99.0%(95/96)94.3-99.8	99.0%(95/96)94.3-99.8	97.9%(94/96)92.7-99.4	99.0%(95/96)94.3-99.8	99.0%(95/96)94.3-99.8
MP	100%(96/96)96.2-100	99.0%(95/96)94.3-99.8	100%(96/96)96.2-100	100%(96/96)96.2-100	100%(96/96)96.2-100	100%(96/96)96.2-100	100%(96/96)96.2-100	97.9%(94/96)92.7-99.4

Table 3: MAX CTGCTV2 Site-to-Site Reproducibility Study Results (Percent Agreement with Expected Results)

ª For the True Negative (TN) category, the reported agreement indicates the percent of negative results.

b For the High Negative (HN) category, the reported agreement indicates the percent of positive results. ° PreservCyt LBC

Table 4:	C. trachomatis Site-to-Site Quantitative Reproducibility Across Sites with Pooled
	Days, Runs and Replicates

MatrixType	Cat	Agree/N	Mean	Within Run		Between Run		BetweenDay		BetweenOperator		BetweenSite		Total
				SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Swab	HN	20/96	36.6	1.1	3.1	1.8	4.9	0.1	0.4	0.0	0.0	0.0	0.0	2.1	5.8
Swab	LP	96/96	33.2	0.7	2.1	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.1	0.7	2.1
Swab	MP	96/96	32.1	0.6	2.0	0.0	0.0	0.2	0.5	0.0	0.0	0.1	0.4	0.7	2.1
Urine	HN	34/96	36.8	1.6	4.3	0.0	0.0	0.8	2.1	0.0	0.0	0.4	1.0	1.8	4.9
Urine	LP	96/96	32.9	0.7	2.3	0.0	0.0	0.7	2.0	0.3	0.9	0.0	0.0	1.1	3.2
Urine	MP	95/96	33.9	1.1	3.1	0.1	0.4	0.2	0.4	0.0	0.0	0.0	0.0	1.1	3.2
LBCa	HN	21/96	38.1	0.7	1.9	2.0	5.1	0.0	0.0	1.4	3.8	0.0	0.0	2.5	6.6
LBCa	LP	96/96	34.6	1.1	3.2	0.4	1.2	0.3	0.9	0.0	0.0	0.7	2.0	1.4	4.0
LBCa	MP	96/96	33.1	0.6	1.8	0.0	0.0	0.2	0.7	0.0	0.0	0.2	0.7	0.7	2.1

a PreservCyt LBC

{11}------------------------------------------------

Target	MatrixType	Cat	Agree/N	Mean	WithinRun		BetweenRun		BetweenDay		BetweenOperator		BetweenSite		Total
					SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
GC1	Swab	HN	33/96	36.3	2.1	5.7	0.9	2.5	0.0	0.0	0.0	0.0	0.6	1.7	2.3	6.4
	Swab	LP	95/96	32.5	0.9	2.8	0.0	0.0	0.3	0.9	0.0	0.0	0.1	0.3	1.0	2.9
	Swab	MP	96/96	31.4	0.5	1.5	0.0	0.0	0.0	0.0	0.0	0.1	0.1	0.2	0.5	1.5
GC1	Urine	HN	27/96	36.5	2.1	5.8	0.0	0.0	0.0	0.0	0.0	0.0	0.7	2.0	2.2	6.1
	Urine	LP	95/96	32.5	1.1	3.4	0.0	0.0	0.0	0.0	0.0	0.0	0.2	0.5	1.1	3.5
	Urine	MP	96/96	32.8	0.9	2.6	0.4	1.3	0.0	0.0	0.0	0.0	0.0	0.0	1.0	2.9
GC1	LBCa	HN	11/96	35.5	1.4	3.9	0.0	0.0	0.9	2.7	0.0	0.0	0.0	0.0	1.7	4.7
	LBCa	LP	94/96	32.1	0.5	1.6	0.4	1.2	0.3	1.0	0.1	0.4	0.1	0.4	0.7	2.3
	LBCa	MP	96/96	30.7	0.5	1.5	0.5	1.5	0.0	0.0	0.0	0.0	0.4	1.2	0.7	2.4
GC2	Swab	HN	33/96	34.2	1.1	3.2	0.1	0.4	0.0	0.0	0.0	0.0	0.0	0.0	1.1	3.2
	Swab	LP	95/96	30.9	0.7	2.2	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.7	2.2
	Swab	MP	96/96	29.8	0.4	1.3	0.0	0.0	0.0	0.0	0.1	0.4	0.2	0.7	0.4	1.5
GC2	Urine	HN	27/96	34.8	1.4	4.0	0.9	2.5	0.0	0.0	0.4	1.1	0.5	1.5	1.8	5.1
	Urine	LP	95/96	31.0	0.7	2.4	0.0	0.0	0.0	0.0	0.1	0.2	0.0	0.0	0.7	2.4
	Urine	MP	96/96	31.2	0.6	1.9	0.0	0.0	0.0	0.0	0.0	0.0	0.2	0.8	0.6	2.1
GC2	LBCa	HN	11/96	35.3	0.8	2.2	1.1	3.1	0.0	0.0	0.0	0.0	0.8	2.3	1.6	4.5
	LBCa	LP	94/96	30.5	0.4	1.2	0.4	1.3	0.3	1.1	0.0	0.0	0.2	0.8	0.7	2.2
	LBCa	MP	96/96	29.2	0.3	1.1	0.4	1.3	0.2	0.7	0.1	0.5	0.3	1.0	0.6	2.2

N. gonorrhoeae Site-to-Site Quantitative Reproducibility Across Sites with Pooled Table 5: Days, Runs and Replicates

a PreservCyt LBC

Table 6: T. vaginalis Site-to-Site Quantitative Reproducibility Across Sites with Pooled Days, Runs and Replicates

MatrixType	Cat	N/ Sus													Mean	Within Run		Between Run		BetweenDay		BetweenOperator		BetweenSite		Total
				SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Swab	HN	36/96	36.9	1.8	5.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	1.8	5.0
	LP	તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય	33.2	0.7	2.2	0.0	0.0	0.0	0.0	0.0	0.0	0.2	0.7	0.8	2.3
	MP	તે જિલ્લાનું મુખ્યત્વે ખેત-ઉત્પાદન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની	32.3	0:5	1.6	0.0	0.0	0.0	0.0	0.1	0.3	0.0	0.0	0:5	1.6
	HN	75/96	37.2	2.4	6.6	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	2.4	6.6
Urine	LP	તે તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી	32.5	0.7	2.2	0.0	0.0	0.3	0.9	0.2	0.6	0.2	0:5	0.8	2.5
	MP	94/96	33.7	0.8	2.4	0.3	1.0	0.0	0.0	0.0	0.0	0.0	0.0	0.9	2.6

For the Lot-to-Lot reproducibility study, two operators each completed a single run of each panel member on two instruments for each of three lots of reagents over an 8-day period, at one testing site. The panels used were the same as described under the Precision heading, above. Results from one reagent lot of the site to site reproducibility study were used to comprise data for one lot of reagents for the Lot-to-Lot study.

The overall Lot-to-Lot reproducibility percent agreement across all targets ranged from 99.4% to 100% for TN, 10.4% to 75.0% for HN, 95.8% to 100% for LP and 95.8% to 100% for MP categories (Table 7). The Lot-to-Lot quantitative reproducibility according to Ct score is also shown in Table 8 to Table 10.

{12}------------------------------------------------

Category	Chlamydia trachomatis(n), 95% CI			Neisseria gonorrhoeae(n), 95% CI			Trichomonas vaginalis(n), 95% CI
	Swab	Urine	LBCc	Swab	Urine	LBCc	Swab	Urine
TNa	99.4%(668/672)98.5-99.8	100%(672/672)99.4-100	99.6%(669/672)98.7-99.8	99.9%(671/672)99.2-100	100%(672/672)99.4-100	100%(672/672)99.4-100	100%(672/672)99.4-100	100%(672/672)99.4-100
HNb	22.9%(22/96)15.6-32.3	37.5%(36/96)28.5-47.5	15.6%(15/96)9.7-24.2	24.0%(23/96)16.5-33.4	24.0%(23/96)16.5-33.4	10.4%(10/96)5.8-18.1	40.6%(39/96)31.3-50.6	63.5%(61/96)53.6-72.5
LP	100%(96/96)96.2-100	100%(96/96)96.2-100	99.0%(95/96)94.3-99.8	99.0%(95/96)94.3-99.8	95.8%(92/96)89.8-98.4	100%(96/96)96.2-100	99.0%(95/96)94.3-99.8	99.0%(95/96)94.3-99.8
MP	100%(96/96)96.2-100	100%(96/96)96.2-100	100%(96/96)96.2-100	100%(96/96)96.2-100	95.8%(92/96)89.8-98.4	100%(96/96)96.2-100	100%(96/96)96.2-100	100%(96/96)96.2-100

Table 7: Lot-to-Lot Reproducibility (Percent Agreement with Expected Results)

ª For the True Negative (TN) category, the reported agreement indicates the percent of negative results.

b For the High Negative (HN) category, the reported agreement indicates the percent of positive results. ° PreservCyt LBC

Chlamydia trachomatis Lot-to-Lot Quantitative Reproducibility Study Results Table 8:

MatrixType	Cat	Agree/N	Mean	Within Run		Between Run		BetweenDay		BetweenOperator		BetweenLot		Total
				SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Swab	HN	22/96	37.3	1.1	2.9	2.2	5.9	1.2	3.1	0.0	0.0	0.0	0.0	2.7	7.3
	LP	96/96	33.6	1.0	2.9	0.4	1.2	0.0	0.0	0.2	0.6	0.3	0.7	1.1	3.3
	MP	96/96	32.6	0.8	2.3	0.0	0.0	0.3	1.0	0.1	0.4	0.1	0.3	0.8	2.6
Urine	HN	36/96	38.0	2.9	7.8	0.0	0.0	0.0	0.0	0.0	0.0	0.3	0.8	3.0	7.8
	LP	96/96	32.9	0.6	1.8	0.5	1.6	0.0	0.0	0.2	0.5	0.0	0.0	0.8	2.4
	MP	96/96	34.0	1.0	3.0	0.1	0.4	0.0	0.0	0.3	0.8	0.2	0.6	1.1	3.2
LBCa	HN	15/96	38.8	1.8	4.7	1.4	3.6	0.0	0.0	1.2	3.0	0.0	0.0	2.6	6.7
	LP	95/96	34.8	1.1	3.0	0.4	1.0	0.0	0.0	0.3	0.9	0.0	0.0	1.2	3.3
	MP	96/96	33.4	0.7	2.0	0.3	1.0	0.4	1.3	0.2	0.7	0.0	0.0	0.9	2.7

a PreservCyt LBC

{13}------------------------------------------------

Target	MatrixType	Cat	Agree/N	Mean	Within Run		Between Run		BetweenDay		BetweenOperator		BetweenLot		Total
					SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
GC1	Swab	HN	23/96	36.4	1.5	4.1	0.0	0.0	1.3	3.6	1.0	2.9	1.1	2.9	2.5	6.8
		LP	95/96	32.7	1.5	4.4	0.6	1.7	0.0	0.0	0.0	0.0	0.0	0.0	1.6	4.7
		MP	96/96	31.6	0.7	2.2	0.1	0.4	0.0	0.0	0.0	0.0	0.2	0.7	0.8	2.4
GC1	Urine	HN	23/96	36.8	2.5	6.8	0.0	0.0	0.0	0.0	0.0	0.0	0.7	2.0	2.6	7.1
		LP	92/96	32.6	1.3	4.0	0.0	0.0	0.0	0.0	0.0	0.0	0.1	0.2	1.3	4.0
		MP	92/96	32.8	0.9	2.8	0.2	0.8	0.0	0.0	0.0	0.0	0.1	0.2	1.0	2.9
	LBC a	HN	10/96	37.8	2.9	7.6	0.0	0.0	0.0	0.0	0.0	0.0	3.5	9.4	4.6	12.1
		LP	96/96	32.1	0.6	1.8	0.0	0.1	0.1	0.5	0.2	0.7	0.0	0.0	0.6	2.0
		MP	96/96	30.7	0.5	1.7	0.3	0.9	0.4	1.4	0.3	1.0	0.0	0.0	0.8	2.6
GC2	Swab	HN	23/96	35.4	1.1	3.2	1.1	3.0	1.7	4.8	0.0	0.0	1.0	2.8	2.5	7.1
		LP	95/96	31.1	0.7	2.2	0.3	0.8	0.0	0.0	0.0	0.0	0.2	0.6	0.8	2.4
		MP	96/96	30.2	0.6	2.1	0.2	0.5	0.0	0.0	0.0	0.0	0.2	0.8	0.7	2.3
GC2	Urine	HN	23/96	35.1	1.8	5.2	1.3	3.7	1.0	2.9	0.0	0.0	0.0	0.0	2.5	7.0
		LP	92/96	31.1	0.8	2.7	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.8	2.7
		MP	92/96	31.6	0.7	2.4	0.0	0.0	0.0	0.0	0.2	0.6	0.0	0.0	0.8	2.4
	LBC a	HN	10/96	36.0	1.1	3.0	0.0	0.0	1.2	3.3	0.0	0.0	1.1	3.0	1.9	5.3
		LP	96/96	30.6	0.4	1.2	0.5	1.5	0.1	0.3	0.2	0.8	0.0	0.0	0.7	2.1
		MP	96/96	29.4	0.4	1.5	0.3	1.1	0.3	1.2	0.3	1.0	0.0	0.0	0.7	2.4

Table 9: Neisseria gonorrhoeae Lot-to-Lot Quantitative Reproducibility Study Results

ª PreservCyt LBC

Table 10: Trichomonas vaginalis Lot-to-Lot Quantitative Reproducibility Study Results

Matrix	Cat	Agree/N	Mean	Within Run		BetweenRun		BetweenDay		BetweenOperator		BetweenLot		Total
Type				SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Swab	HN	39/96	36.8	2.1	5.8	0.0	0.0	0.0	0.0	0.3	0.7	0.0	0.0	2.1	5.8
	LP	95/96	33.4	1.2	3.7	0.0	0.0	0.3	0.9	0.0	0.0	0.3	1.0	1.3	4.0
	MP	96/96	32.4	0.7	2.3	0.1	0.4	0.1	0.3	0.1	0.2	0.0	0.0	0.8	2.4
Urine	HN	61/96	37.0	1.9	5.2	0.0	0.0	0.5	1.2	0.0	0.0	0.0	0.0	2.0	5.4
	LP	95/96	32.5	0.7	2.1	0.1	0.3	0.0	0.0	0.0	0.0	0.1	0.4	0.7	2.1
	MP	96/96	33.8	1.0	3.1	0.0	0.0	0.0	0.0	0.2	0.5	0.0	0.0	1.1	3.1

Sample Storage

Swab specimens must be transferred to a BD MAX Swab Sample Buffer Tube immediately after collection. First void urine specimens must be transferred from the collection cup to the BD MAX Urine Sample Buffer Tube immediately after collection. Once in the BD MAX Sample Buffer Tube, swab and urine specimens can be stored for up to 21 days at 2-30 ℃ and then up to an additional 30 days at -20 ℃ (Table 11).

{14}------------------------------------------------

Specimen Stability	Transport and/or Storage Time/Temperature
In BD MAX Swab or UrineSample Buffer Tube	Up to 21 days at 2-30 °Cand then up to an additional30 days at -20 °C

LBC specimens in the vial prior to transfer to the BD MAX LBC Sample Buffer Tube can be stored up to 14 days at 2-30 ℃. Once in the BD MAX LBC Sample Buffer Tube, samples can be stored for up to 21 days at 2-30 °C and then up to an additional 30 days at -20 °C, prior to or after pre-warm (Table 12).

Specimen Stability	Transport and/or Storage Time/Temperature
Prior to transfer to BD MAX LBC SampleBuffer Tube	Up to 14 days at 2-30 °C
In BD MAX LBC Sample Buffer Tube(prior to or after pre-warm)	Up to 21 days at 2-30 °C
In BD MAX LBC Sample Buffer Tube(after pre-warm)	and then up to an additional30 days at -20 °C

Table 5: LBC Specimen Storage and Transport

Swab and Urine Specimen Storage and Transport

Controls

External Control materials are not provided by BD; however, Quality Control strains and procedures are included in the package insert. Various types of External Controls are recommended to allow the user to select the most appropriate for their laboratory quality control program:

Commercially available positive control materials:

Table 4:

Chlamydia trachomatis serovar H (ATCC VR-879)

Neisseria gonorrhoeae (ATCC 19424)

Trichomonas vaginalis (ATCC 30001)

External negative control

Use a non-inoculated BD MAX Swab Sample Buffer Tube

The assay includes a Specimen Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances.

Analytical Sensitivity

The analytical sensitivity/Limit of Detection (LoD) in urine, vaginal swab and PreservCyt LBC specimen matrix was determined by preparing microbial suspensions from each of two (2) representative strains of the target organisms inoculated into pooled female urine, pooled vaginal swab and pooled PreservCyt LBC matrix in sample buffer with multiple concentrations of each representative strain. Each matrix suspension was tested with at least 20 replicates per LoD concentration across 3 different reagent lots. Analytical sensitivity (LoD), defined as the lowest concentration at which at least 95% of all replicates tested positive, is represented in Table 13.

{15}------------------------------------------------

Organism	Strain	Specimen	LoD Concentration (units/mL)a
Chlamydia trachomatis	Serovar H	Urine	2.5
		Swab	2.5
		PreservCyt	5
Chlamydia trachomatis	Serovar D	Urine	1.25
		Swab	5
		PreservCyt	5
Neisseria gonorrhoeae	ATCC 19424	Urine	30
		Swab	15
		PreservCyt	30
Neisseria gonorrhoeae	ATCC 49226	Urine	15
		Swab	30
		PreservCyt	60
Trichomonas vaginalis	ATCC 30001	Urine	5
		Swab	7.5
Trichomonas vaginalis	ATCC 50143	Urine	2.5
		Swab	1.88

Table 6: BD MAX CTGCTV2 Limits of Detection

ª Units/mL LoD concentration represented in Elementary Bodies (EB)/mL for Chlamydia trachomatis, cells/mL for Neisseria gonorrhoeae and TV/mL for Trichomonas vaginalis.

Analytical Inclusivity

Inclusivity testing was performed for 13 additional Chlamydia trachomatis serovars, 30 additional Neisseria gonorrhoeae strains and 8 additional Trichomonas vaginalis strains by spiking into female urine, vaginal swab and PreservCyt LBC pools prepared in sample buffer at concentrations targeting the predetermined LoD for each organism. Each serovar/strain was tested in 20 replicates with at least three different reagent lots. The results for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are presented in Table 16 through Table 16 and show the concentrations which were detected in at least 19/20 replicates (≥95%).

		Swab		Urine		PreservCyt
Organism	Serovar	EBs/mL	% POS	EBs/mL	% POS	EBs/mL	% POS
Chalmydiatrachomatis	A	5	100	2.5	100	5	100
	B	5	100	2.5	100	5	100
	C	5	> 95	2.5	100	5	100
	E	5	100	2.5	100	5	100
	F	5	100	2.5	100	5	100
	G	5	100	2.5	100	5	100
	I	5	100	2.5	100	5	100
	J	5	100	2.5	100	5	100
	K	5	100	2.5	100	5	100
	LGV1	5	100	2.5	100	5	100
	LGV2	5	100	2.5	100	5	100
	LGV3	5	100	2.5	100	5	100
	vE	5	100	2.5	100	5	100

Table 7: Inclusivity Results – Chlamydia trachomatis

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Organism	NumberStrains	Swab		Urine		PreservCyt
		Cells/mL	% POS	Cells/mL	% POS	Cells/mL	% POS
Neisseriagonorrhoeae	30	NA	NA	NA	NA	60	≥95
	27	30	≥95	NA	NA	NA	NA
	3	45	≥95	NA	NA	NA	NA
	29	NA	NA	30	≥95	NA	NA
	1	NA	NA	45	100	NA	NA

Table 8: Inclusivity Results – Neisseria gonorrhoeae

Organism	ATCCStrain	Swab		Urine
		TV/mL	% POS	TV/mL	% POS
Trichomonasvaginalis	30092	7.5	100	5	100
	30184	7.5	≥ 95	5	100
	30185	7.5	100	5	100
	30186	7.5	≥ 95	5	100
	30235	7.5	100	5	100
	30236	7.5	100	5	100
	30238	7.5	≥ 95	5	100
	30240	7.5	100	5	100

Table 9: Inclusivity Results - Trichomonas vaginalis

Analytical Specificity

The BD MAX CTGCTV2 assay was performed on samples containing phylogenetically related microorganisms likely to be found in urogenital specimens (Table 17). The bacterial cells, yeasts, viruses and parasites were tested in the Sample Buffer Tube at 2x106 cells/mL, genomic DNA cp/mL, or EB/mL, and viruses were tested at 1x105 viral particles or genomic equivalents/mL.

98% of bacterial strains, yeasts, parasites and viruses tested produced negative results with the BD MAX CTGCTV2. Pentatrichomonas hominis (commensal of the large intestine) produced positive results at a concentration ≥ 1.00 x 105 TV/mL for Trichomonas vaginalis and negative results for all other targets with the BD MAX CTGCTV2 assay. Trichomonas tenax (commensal of the oral cavity) produced positive results at a concentration ≥ 1.88 TV/mL for Trichomonas vaginalis and negative results for all other targets with the BD MAX CTGCTV2 assay.

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Organism	Organism	Organism
Achromobacter xerosis	Escherichia coli	Neisseria mucosa (3) a
Acinetobacter calcoaceticus	Escherichia vulneris	Neisseria perflava
Acinetobacter lwoffi	Fuseobacterium nucleatum	Neisseria polysaccharea
Actinomyces israelii	Gardnerella vaginalis	Neisseria sicca (3)
Actinomyces pyogenes	Gemella haemolysans	Neisseria subflava (14) a
Aerococcus viridans	Haemophilus ducreyi	Paracoccus denitrificans
Aeromonas hydrophilia	Haemophilus influenzae	Pentatrichomonas hominis
Agrobacterium radiobacter	Herpes Simplex Virus I	Peptostreptococcus anaerobius
Alcaligenes faecalis	Herpes Simplex Virus II	Peptostreptococcus productus
Atopobium vaginae	HIV 1	Plesiomonas shigelloides
Bacillus subtilis	HPV 16	Prevotella bivia
Bacteroides fragilis	Kingella dentrificans	Propionibacterium acnes
Bacteroides ureoeolyticus	Kingella kingae	Proteus mirabilis
Bifidobacterium adolescentis	Klebsiella oxytoca	Proteus vulgaris
Bifidobacterium brevi	Klebsiella pneumoniae	Providencia stuartii
Blastocystis hominis	Lactobacillus acidophilus	Pseudomonas aeruginosa
Branhamella catarrhalis	Lactobacillus brevis	Pseudomonas fluorescens
Brevibacterium linens	Lactobacillus jensenii	Pseudomonas putida
Campylobacter jejuni	Lactobacillus lactis	Rahnella aquatilis
Candida albicans	Lactobacillus vaginalis	Rhodospirilium rubrum
Candida gabralta	Legionella pneumophilia (2) a	Saccharomyces cerevisiae
Candida parapsilosis	Leuconostoc paramensenteroides	Salmonella minnesota
Candida tropicalis	Listeria monocytogenes	Salmonella typhimurium
Chlamydiophila pneumoniae	Micrococcus leutus	Serratia marcescens
Chlamydiophila psittaci (2) a	Mobiluncus curtisii	Staphylococcus aureus,non-protein
Chromobacterium violaceum	Moraxella lacunata	Staphylococcus aureus, protein-A
Citrobacter freundii	Moraxella osloensis	Staphylococcus epidermidis
Clostridium difficile	Morganella morganii	Staphylococcus saprophyticus
Clostridium perfringens	Mycobacterium smegmatis	Streptococcus bovis
Corynebacterium genitalium biovar1	Mycoplasma genitalium	Streptococcus agalactiae (Group B)
Corynebacterium xerosis	Mycoplasma hominis	Streptococcus mitis
Cryptococcus neoformans	Neisseria cinerea (4)a	Streptococcus mutans
Cytomegalovirus	Neisseria denitrificans	Streptococcus pneumoniae
Deinococcus radiodurans	Neisseria elongate (3) a	Streptococcus pyogenes (Group A)
Derxia gummosa	Neisseria flava	Streptococcus salivarius
Eikenella corrodens	Neisseria flavescens (2) a	Streptococcus sanguis
Elizabethkingia meningosepticum	Neisseria lactamica (9) a	Streptomyces griseinus
Enterobacter aerogenes	Neisseria meningitidis A	Trichomonas tenax
Enterobacter cloacae	Neisseria meningitidis B	Ureaplasma urealyticum
Enterococcus avium	Neisseria meningitidis C (4) a	Vibrio parahaemolyticus
Enterococcus faecalis	Neisseria meningitidis D	Yersinia enterocolitica
Enterococcus faecium	Neisseria meningitidis W135
Erysipelothrix rhusiopathiae	Neisseria meningitidis Y

Table 17: Specificity Organisms (Bacteria, Yeasts, Parasites and Viruses)

a The number in parenthesis indicates the number of strains tested.

Interfering Substances

Forty-four (44) biological and chemical substances that may be present in urogenital specimens were evaluated for potential interference at concentrations that may be found in urogenital specimens.

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Negative urine, vaginal swab and PreservCyt LBC pooled specimens and a target mix of Chlamydia trachomatis. Neisseria gonorrhoeae and Trichomonas vaginalis positive at 3X LoD were tested with each substance. Potentially interfering substances in urine specimens include whole blood. Potentially interfering substances in vaginal swab specimens include VCF Contraceptive Foam and Film, Conceptrol Contraceptive Gel, Monistat 3 cream, Vaginal Anti-Itch Cream, McKesson Lubricating Jelly, Surgilube, Aquagel, Acyclovir, Metronidazole, Replens, mucous and whole blood. Potentially interfering substances in PreservCyt LBC specimens include Vaginal Anti-Itch Cream, Metronidazole Gel, Replens, mucous, whole blood, McKesson Lubricating Jelly, Surgilube and Aquagel. The following substances shown in Table 18 through Table 20 did not cause interference with the BD MAX CTGCTV2 assays at the concentrations shown below.

Substance	Concentration
Norethindrone	16 ng/mL
17-α-Ethinylestradiol	0.96 ng/mL
4-Acetamidophenol	160 µg/mL
Acetylsalicylic Acid	521.6 µg/mL
Naproxen	400 µg/mL
Ibuprofen	400 µg/mL
Human Serum Albumin	0.8 mg/mL
Glucose	0.96 mg/mL
Amoxicillin Trihydrate	60.16 µg/mL
Metronidazole	96 µg/mL
Tetracycline Hydrochloride	12 µg/mL
Azithromycin	9.6 µg/mL
Ceftriaxone	648.8 µg/mL
Sulfamethoxazole	320 µg/mL
Trimethoprim	32 µg/mL
Erythromycin	48 µg/mL
Mucous (Bovine Cervical)	4% v/v
Whole Blood	0.6% v/v a
Semen	4% v/v
Leukocytes	2x106 cells/mL
Phenazopyridine Hydrochloride	160 µg/mL
High pH (NaOH)	pH 9
Low pH (HCl)	pH 4
Bilirubin	0.16 mg/mL
Feminine Deodorant Spray	0.68% v/v
Talcum Powder	2.64% v/v

Table 108:	Endogenous and Exogenous Substances Tested for Interference in Urine

a May interfere with the BD MAX CTGCTV2 assay when at concentrations higher than shown.

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Substance	Concentration
VCF Contraceptive Foam	15 µL/mLa
VCF Contraceptive Film	0.5 µL/mLa
Conceptrol Contraceptive Gel	3 µL/mLa
Gyne-Lotrimin 3	50 µL/mL
Monistat 3 Cream	0.1 µL/mLa
Tioconazole 1	50 µL/mL
Vaginal Anti-Itch Cream	0.1 µL/mLa
Vaginal Lubricant Liquid - water based	50 µL/mL
Preparation H Hemorrhoid Gel	50 µL/mL
Antiviral (Zovirax – Acyclovir)	0.01 µL/mLa
Metronidazole Gel (AntiProtozoal)	1.25 µL/mLa
Replens (Vaginal Moisturizer)	0.1 µL/mLa
Douche	50 µL/mL
Feminine Deodorant Spray	50 µL/mL
Progesterone	20 ng/mL
Estradiol	1.2 ng/mL
Mucous (Bovine Cervical)	4.5% v/va
Semen	5% v/v
Whole Blood	8 µL/mLa
Leukocytes	1x106 cells/mL
Aquagel	0.0345 mg/mLa
McKesson Lubricating Jelly	0.445 mg/mLa
Surgilube	0.41 mg/mLa
KY Lubricating Jelly	137.5 mg/mL

Table 19: Endogenous and Exogenous Substances Tested for Interference in Swab Specimens

ª May interfere with the BD MAX CTGCTV2 assay when at concentrations higher than shown.

{20}------------------------------------------------

Substance	Concentration
Vaginal Lubricant	2% v/v
Douche	2% v/v
Vaginal Deodorant Spray	2% v/v
Progesterone	20 ng/mL
Estradiol	1.2 ng/mL
Leukocytes	1 x 106 cells/mL
Semen	2% v/v
Monistat 3	2% v/v
Clotrimazole 7	2% v/v
Tioconazole 1	2% v/v
Vaginal contraceptive film	2% v/v
Vaginal contraceptive foam	2% v/v
Contraceptive gel	2% v/v
Vaginal anti-itch Cream	1% v/va
Zovirax (Acyclovir) Cream	2% v/v
Metronidazole Gel 0.75%	0.01% v/va
Replens (Vaginal Moisturizer)	0.1% v/va
Mucous (Bovine Cervical)	1.9% v/va
Whole Blood	0.5% v/va
Aquagel	0.276 mg/mLa
McKesson Lubricating Jelly	3.56 mg/mLa
Surgilube	328 mg/mLa
KY Lubricating Jelly	1.100 mg/mLa

Table 20: Endogenous and Exogenous Substances Tested for Interference in PreservCyt LBC Specimens

a May interfere with the BD MAX CTGCTV2 assay when at concentrations higher than shown.

Carryover/Cross-Contamination

High positive samples containing Chlamydia trachomatis (VR-879, Serovar H) spiked into pooled PreservCyt LBC matrix at a concentration of >1 x 10 EB/mL were processed with negative samples consisting of LBC Sample Buffer Tubes without any target analyte. Twelve (12) replicates of the high positive panel member and 12 replicates of the negative panel member were tested in 18 runs by alternating negative and positive samples, using three BD MAX instruments for a total of 216 positive and 216 negative samples tested. Of the 216 negative samples tested, two false positive results were obtained (0.93%, 95% CI: 0.25% - 3.31%).

Mixed Infection/Competitive Interference

Three test samples prepared in pooled clinical matrix (swab, urine and PreservCyt LBC) each containing one of the target organisms (Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis) at 1.5X their respective LoD, were tested with a high target mix comprised of the other two BD MAX CTGCTV2 analytes at a concentration ≥ 1x10 EB, cells or TV/mL to simulate mixed infections. The samples were tested in 20 replicates. All three low target organisms were successfully detected at ≥95% by the BD MAX CTGCTV2 assay in the presence of the other two organisms at high concentrations in urine, vaginal swab and PreservCyt LBC specimens. When assessed across all organisms and sample types, the observed Ct score shift ranged from -0.1 to 4.5 for Chlamydia

{21}------------------------------------------------

trachomatis, from -1.8 to 5.8 for Neisseria gonorrhoeae, and from 1.0 to 4.8 for Trichomonas vaginalis.

Clinical Performance Studies

Twelve geographically diverse clinical sites in North America participated in the clinical trial to evaluate the BD MAX CTGCTV2 assay. Two thousand five hundred and forty-seven (2,547) female subjects and 1.159 male subjects representing ages 18 and over were enrolled from sexually transmitted disease (STD). OB/GYN, and family planning clinics. Subjects were classified as symptomatic if they reported symptoms such as dysuria, urethral discharge, itching, odor, coital pain/difficulty/bleeding, testicular or scrotum pain/swelling, abnormal vaginal discharge, or pelvic/ uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report these symptoms.

Eight specimens were collected from each eligible female subject: one first-catch urine, two randomized patient-collected vaginal swab specimens, two randomized clinician-collected vaginal swab specimens, two randomized endocervical swab specimens and one PreservCyt LBC specimen (collected using either the cervical broom or brush/spatula). One urine specimen was collected from each of the eligible male subjects. Samples were prepared for BD MAX CTGCTV2 and reference testing in accordance with the appropriate specimen collection kit package insert instructions.

All specimens from enrolled subjects were tested across five clinical trial testing sites. Samples with initial non-reportable (Unresolved, Indeterminate or Incomplete) results were repeated from the BD MAX Sample Buffer Tube. Following a valid repeat test, 0.3% (38/13,649) specimens remained nonreportable and were excluded from the sensitivity and specificity statistical analysis. The final data analysis included 2,536 evaluable female subjects and 1,149 evaluable male subjects. The estimates of performance of the BD MAX CTGCTV2 assay for Chlamydia trachomatis included: 2,508 patientcollected vaginal swabs, 2,502 clinician-collected vaginal swabs, 2,512 endocervical swabs, 2,469 PreservCyt LBC, 2,416 female urine and 1,140 male urine specimens. The estimates of performance of the BD MAX CTGCTV2 assay for Neisseria gonorrhoeae included: 2.506 patient-collected vaginal swabs, 2,503 clinician-collected vaginal swabs, 2,511 endocervical swabs, 2,470 PreservCyt LBC, 2,419 female urine and 1,142 male urine specimens. The estimates of performance of the BD MAX CTGCTV2 assay for Trichomonas vaginalis included: 1,742 patient-collected vaginal swabs, 1,732 cliniciancollected vaginal swabs, 1,646 female urine and 1,141 male urine specimens. Exclusions included but were not limited to: missing specimens and/or reference test results, transport, collection, shipping, and/or processing errors.

Clinical Performance of Chlamydia trachomatis and Neisseria gonorrhoeae

The clinical performance of the BD MAX CTGCTV2 for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in females and males was calculated compared to a Patient Infected Status (PIS). The female PIS was established by testing urine and cervical specimens with two different FDA cleared NAATs (Nucleic Acid Amplification Test) where female subjects were designated as infected if at least two different reference NAATs were positive for urine and cervical specimens. For the purpose of data analysis, females who tested positive with the two comparator NAATs in urine only (negative in swabs with both NAATs), were considered non-infected when calculating the performance of the assay for swab specimens. The male PIS was established by testing urine specimens using up to three different FDA cleared NAATs where male subjects were designated as infected if 2 out of 3 reference NAAT results were positive. Subjects were categorized as non-infected if 2 out of 3 reference NAAT results were negative. The resulting performance is shown in Table 21.

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Gender	SpecimenType	Symptomstatus	Chlamydia trachomatis		Neisseria gonorrhoeae		Gender	Specimen Type	Symptomstatus	Trichomonas vaginalis
			% Sens	% Spec	% Sens	% Spec				% Sens	% Spec
Female	VaginalClinician	A	98.255/5690.6-99.7	98.81,076/1,08998-99.3	10015/1579.6-100	99.81,129/1,13199.4-100	Female	Vaginal Clinician	A	98.566/6792.0-99.7	99.6687/69098.7-99.9
		S	98.671/7292.5-99.8	99.01,272/1,28598.3-99.4	96.427/2882.3-99.4	99.91,328/1,32999.6-100			S	97.5116/11992.8-99.1	99.6853/85699.0-99.9
		All	98.4126/12894.5-99.6	98.92,348/2,37498.4-99.3	97.742/4387.9-99.6	99.92,457/2,46099.6-100			All	97.8182/18694.6-99.2	99.61540/154699.2-99.8
	Vaginal Self	A	98.255/5690.6-99.7	98.91,077/1,08998.1-99.4	10015/1579.6-100	99.61,126/1,13099.1-99.9		Vaginal Self	A	97.065/6789.8-99.2	99.1685/69198.1-99.6
		S	98.671/7292.5-99.8	98.51,271/1,29197.6-99	10028/2887.9-100	1001,333/1,33399.7-100			S	98.4120/12294.2-99.5	99.2855/86298.3-99.6
		All	98.4126/12894.5-99.6	98.72,348/2,38098.1-99	10043/4391.8-100	99.82,459/2,46399.6-99.9			All	97.9185/18994.7-99.2	99.21540/155398.6-99.5
	Endo-cervical	A	96.454/5687.9-99	99.41,084/1,09098.8-99.7	10015/1579.6-100	99.91,131/1,13299.5-100			A	96.225/2681.1-99.3	99.6678/68198.7-99.9
		S	93.167/7284.8-97	99.11,282/1,29498.4-99.5	92.926/2877.4-98	1001,336/1,33699.7-100			S
		All	94.5121/12889.1-97.3	99.22,366/2,38498.8-99.5	95.341/4384.5-98.7	1002,467/2,46899.8-100			All
	LBCPreserv-Cyt	A	92.650/5482.4-97.1	99.71,076/1,07999.2-99.9	10015/1579.6-100	99.91,118/1,11999.5-100	Male	Urine	A	96.225/2681.1-99.3	99.6678/68198.7-99.9
		S	92.965/7084.3-96.9	99.81,264/1,26699.4-100	88.924/2771.9-96.1	1001,309/1,30999.7-100			S	10022/2285.1-100	100412/41299.1-100
		All	92.7115/12486.8-96.1	99.82,340/2,34599.5-99.9	92.939/4281-97.5	1002,427/2,42899.8-100			All	97.947/4889.1-99.6	99.71,090/1,09399.2-99.9
Male	Urine	A	97.371/7390.5-99.2	99.6667/67098.7-99.8	10012/1275.8-100	100732/73299.5-100
		S	96.377/8089.5-98.7	99.1314/31797.3-99.7	99.1110/11195.1-99.8	99.7286/28798.1-99.9
		All	96.7148/15392.6-98.6	99.4981/98798.7-99.7	99.2122/12395.5-99.9	99.91,018/1,01999.4-100

Table 21: Chlamydia trachomatis and Neisseria gonorrhoeae Performance Compared to PIS

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Clinical Performance of Trichomonas vaginalis

The clinical performance of the BD MAX CTGCTV2 for the detection of Trichomonas vaginalis infection in females and males was calculated compared to a PIS. The female PIS was established by testing vaginal specimens with two different FDA cleared molecular tests, across three different instrument platforms, where female subjects were designated as infected if 2 out of 3 reference test results were positive. Subjects were categorized as non-infected if 2 out of 3 reference test results were negative. The male PIS was established by testing urine specimens using up to three different FDA cleared NAATs where male subjects were designated as infected if 2 out of 3 reference test results were positive. Subjects were categorized as non-infected if 2 out of 3 reference test results were negative. The resulting performance is shown in Table 22.

Table 22: Trichomonas vaginalis Performance Compared to the PIS

Clinical Performance of Female Urine

The clinical performance of the BD MAX CTGCTV2 for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis infection in female urine was calculated compared to a Composite Comparator Algorithm (CCA) utilizing urine samples from up to three reference NAATs to generate reference results for each analyte. Female subjects were designated as positive if 2 out of 3 reference NAAT results were positive. Subjects were categorized as negative if 2 out

{24}------------------------------------------------

of 3 reference NAAT results were negative. The resulting performance expressed as positive percent agreement (PPA) and negative percent agreement (NPA) is shown in Table 23.

Additionally, the results obtained when using urine specimens in females were evaluated against the PIS based on cervical and urine algorithm. In the clinical study conducted for the BD MAX CTGCTV2 assay, female urine detected 5.8% fewer Chlamydia trachomatis infections than clinician and self-collected vaginal swabs and 1.9% fewer Chlamydia trachomatis infections than endocervical swabs. Female urine detected 2.4% fewer Neisseria gonorrhoeae infections than clinician-collected vaginal swabs and 4.7% fewer Neisseria gonorrhoeae infections than patientcollected vaginal swabs. There was no difference in the detection of Neisseria gonorrhoeae infections when comparing female urine and endocervical swabs.

SpecimenType	Symp.Status	Chlamydia trachomatis		Neisseria gonorrhoeae		Trichomonas vaginalis
		PPA	NPA	PPA	NPA	PPA	NPA
Female Urine	A	98.151/5289.9-99.7	99.21,037/1,04598.5-99.6	10014/1478.5-100	99.91,085/1,08699.5-100	10058/5893.8-100	99.8646/64799.1-100
	S	98.670/7192.4-99.8	99.41,241/1,24898.8-99.7	10025/2586.7-100	1001,294/1,29499.7-100	100115/11596.8-100	99.4821/82698.6-99.7
	All	98.4121/12394.3-99.6	99.32,278/2,29398.9-99.6	10039/3991.0-100	1002,379/2,38099.8-100	100173/17397.8-100	99.61,467/1,47399.1-99.8

Table 23: Clinical Performance of BD MAX CTGCTV2 in Female Urine, Compared to the CCA

Of all the specimens initially evaluated with the BD MAX CTGCTV2 assay, 1.1% of vaginal clinician-collected, 1.3% of patient-collected vaginal swab, 0.9% of endocervical swab, 0.2% of PreservCyt LBC and 0.9% of urine specimens initially reported as Unresolved. Following a valid repeat test, 0.3% of clinician-collected vaginal swab, 0.4% of patient-collected vaginal swab, 0.1% of endocervical swab, 0.0% of PreservCyt LBC and 0.1% of urine specimens remained Unresolved. The total numbers in Table 24 are based on compliant specimens and BD MAX CTGCTV2 results.

	Initial Unresolved Rate		Final Unresolved Rate with Valid Repea
Specimen Type	Percent	95% CI	Percent	95% CI
Vaginal Clinician-Collected	1.1% (28/2,517)	(0.8%, 1.6%)	0.3% (7/2,517)	(0.1%, 0.6%)
Vaginal Patient-Collected	1.3% (34/2,525)	(1.0%, 1.9%)	0.4% (10/2,525)	(0.2%, 0.7%)
Endocervical	0.9% (22/2,519)	(0.6%, 1.3%)	0.1% (3/2,516)	(0.0%, 0.3%)
LBC PreservCyt	0.2% (6/2,473)	(0.1%, 0.5%)	0.0% (0/2,471)	(0.0%, 0.2%)
Urine	0.9% (34/3,621)	(0.7%, 1.3%)	0.1% (3/3,620)	(0.0%, 0.2%)

Table 24:	Unresolved Rates
-----------	------------------

I

Of all the specimens initially evaluated with the BD MAX CTGCTV2 assay, 0.7% of cliniciancollected vaginal swab, 0.6% of patient-collected vaginal swab, 0.6% of endocervical swab, 1.2% of PreservCyt LBC and 1.2% of urine specimens initially reported as Incomplete. Following a valid repeat test, 0.0% of all specimen types remained Incomplete. The total numbers in Table 25 are based on compliant specimens and BD MAX CTGCTV2 results.

{25}------------------------------------------------

Specimen Type	Initial Indeterminate RatePercent	95% CI	Final Indeterminate Rate with Valid RepeatPercent	95% CI
Vaginal Clinician-Collected	0.8% (20/2,517)	(0.5%, 1.2%)	0.2% (6/2,517)	(0.1%, 0.5%)
Vaginal Patient-Collected	0.9% (23/2,525)	(0.6%, 1.4%)	0.1% (3/2,525)	(0.0%, 0.3%)
Endocervical	0.8% (19/2,519)	(0.5%, 1.2%)	0.1% (2/2,516)	(0.0%, 0.3%)
LBC PreservCyt	0.2% (6/2,473)	(0.1%, 0.5%)	0.0% (0/2,471)	(0.0%, 0.2%)
Urine	0.2% (9/3,621)	(0.1%, 0.5%)	0.1% (3/3,620)	(0.0%, 0.2%)

Table 25: Indeterminate Rates

Of all the specimens initially evaluated with the BD MAX CTGCTV2 assay, 0.7% of cliniciancollected vaginal swab, 0.6% of patient-collected vaginal swab, 0.6% of endocervical swab, 1.2% of PreservCyt LBC and 1.2% of urine specimens initially reported as Incomplete. Following a valid repeat test, 0.0% of all specimen types remained Incomplete. The total numbers in Table 26 are based on compliant specimens and BD MAX CTGCTV2 results.

	Initial Incomplete Rate		Final Incomplete Rate with Valid Repeat
Specimen Type	Percent	95% CI	Percent	95% CI
Vaginal Clinician-Collected	0.7% (17/2,517)	(0.4%, 1.1%)	0.0% (0/2,517)	(0.0%, 0.2%)
Vaginal Patient-Collected	0.6% (14/2,525)	(0.3%, 0.9%)	0.0% (1/2,525)	(0.0%, 0.2%)
Endocervical	0.6% (14/2,519)	(0.3%, 0.9%)	0.0% (0/2,516)	(0.0%, 0.2%)
LBC PreservCyt	1.2% (30/2,473)	(0.9%, 1.7%)	0.0% (0/2,471)	(0.0%, 0.2%)
Urine	1.2% (45/3,621)	(0.9%, 1.7%)	0.0% (0/3,620)	(0.0%, 0.1%)

Table 26: Incomplete Rates

Expected Values

The positivity rate of the MAX CTGCTV2, as observed during the multi-center clinical study, is shown by specimen type in Table 27 and Table 28.

BD MAX CTGCTV2 Clinical Study Female Positivity Table 117:

% Positive (No. positive/No. of valid results)
Site	Chlamydia trachomatis					Neisseria gonorrhoeae					Trichomonas vaginalis
	CCVSa	SCVSb	Endo	LBCc	Urine	CCVSa	SCVSb	Endo	LBCc	Urine	CCVSa	SCVSb	Urine
1	3.4%10/294	3.4%10/297	3.3%10/299	2.7%8/298	3.1%9/295	0.3%1/294	0.7%2/297	0.3%1/299	0.3%1/298	0.3%1/295	23.1%68/295	23.7%71/299	23.4%69/295
2	3.7%18/486	5.1%25/490	4.7%23/489	3.8%18/471	4.7%23/489	1.0%5/486	0.8%4/489	0.6%3/489	0.4%2/471	0.8%4/489	10.7%52/486	12.0%59/490	11.6%57/491
3	5.3%7/132	6.0%8/133	4.5%6/132	3.8%5/133	4.5%6/134	2.3%3/132	2.3%3/133	2.3%3/132	2.3%3/133	2.2%3/134	6.8%9/132	7.5%10/133	7.5%10/134
4	17.2%5/29	17.2%5/29	17.2%5/29	13.8%4/29	10.3%3/29	3.4%1/29	3.4%1/29	3.4%1/29	3.4%1/29	3.4%1/29	20.7%6/29	20.7%6/29	20.7%6/29
5	7.1%13/182	7.1%13/182	5.5%10/182	6.0%11/182	7.7%14/182	3.3%6/182	3.3%6/182	2.7%5/182	2.7%5/182	2.7%5/182	14.8%27/182	14.3%26/182	14.3%26/182
6	7.3%35/482	7.0%34/483	5.4%26/481	5.2%25/484	6.2%28/453	1.5%7/482	1.7%8/482	1.5%7/481	1.2%6/484	1.5%7/453	6.6%32/482	7.9%38/482	6.6%30/453
7	6.7%5/75	6.7%5/75	7.9%6/76	6.4%5/78	7.9%6/76	0.0%0/75	0.0%0/75	0.0%0/76	0.0%0/78	0.0%0/76	10.7%8/75	12.0%9/75	11.8%9/76
8	3.9%11/283	4.6%13/283	3.9%11/282	3.6%10/276	3.7%10/272	0.0%0/283	0.0%0/282	0.0%0/282	0.0%0/276	0.0%0/272	1.4%4/283	1.1%3/282	1.1%3/272
9	12.8%33/257	11.6%30/259	11.2%29/259	10.6%25/235	10.9%28/256	6.2%16/257	6.6%17/259	6.2%16/257	6.8%16/235	5.5%14/256	18.7%48/257	18.1%47/259	16.8%43/256
10	9.4%12/127	11.0%14/127	10.2%13/127	7.9%10/127	7.9%10/127	4.7%6/127	4.7%6/127	4.7%6/127	4.7%6/127	4.7%6/127	7.9%10/127	7.9%10/127	7.9%10/127
11	2.5%4/157	1.9%3/156	0.6%1/157	0.0%0/157	1.9%3/157	0.0%0/157	0.0%0/156	0.0%0/157	0.0%0/157	0.0%0/157	1.3%2/157	1.3%2/156	1.3%2/157
Total	6.1%153/2504	6.4%160/2514	5.6%140/2513	4.9%121/2470	5.7%140/2470	1.8%45/2504	1.9%47/2511	1.7%42/2511	1.6%40/2470	1.7%41/2470	10.6%266/2505	11.2%281/2514	10.7%265/2472

ª Clinician-collected vaginal swab

b Self-collected vaginal swab

© PreservCyt LBC

{26}------------------------------------------------

% Positive (No. positive/No. of valid results)
Site	Chlamydia trachomatis	Neisseria gonorrhoeae	Trichomonas vaginalis
1	17.0%8/47	2.1%1/47	0.0%0/47
2	18.9%28/148	23.6%35/148	2.0%3/148
3	12.0%35/291	9.6%28/291	5.2%15/291
4	10.0%36/359	7.2%26/359	3.3%12/359
5	13.3%13/98	4.1%4/98	5.1%5/98
6	17.6%35/199	14.6%29/199	7.5%15/199
Total	13.6%155/1,142	10.8%123/1,142	4.4%50/1,142

Table 128: BD MAX CTGCTV2 Clinical Study Male Positivity

Positive and Negative Predictive Value

Hypothetical Positive Predictive Value (PPV) and Negative Predictive Value (NPV) based on observed sensitivity and specificity as compared to the Patient Infected Status are shown in Table 29.

{27}------------------------------------------------

SpecimenType	HypotheticalPrevalence	Chlamydia trachomatis		Neisseria gonorrhoeae		Trichomonas vaginalis
		% PPV95% CI	% NPV95% CI	% PPV95% CI	% NPV95% CI	% PPV95% CI	% NPV95% CI
Vaginala	1%	44.9%(36.3%, 53.9%)	100%(99.9%, 100%)	87.5%(73.8%, 96.1%)	100%(99.9%, 100%)	61.7%(47.3%, 76.4%)	100%(99.9%, 100%)
	2%	62.2%(53.5%, 70.3%)	100%(99.9%, 100%)	93.4%(85.1%, 98.0%)	100%(99.8%, 100%)	76.5%(64.5%, 86.7%)	100%(99.9%, 100%)
	5%	80.9%(74.8%, 85.9%)	99.9%(99.7%, 100%)	97.3%(93.6%, 99.2%)	99.9%(99.6%, 100%)	89.4%(82.4%, 94.4%)	99.9%(99.7%, 100%)
	10%	90.0%(86.2%, 92.8%)	99.8%(99.4%, 100%)	98.7%(96.9%, 99.6%)	99.9%(99.1%, 100%)	94.7%(90.8%, 97.3%)	99.8%(99.4%, 99.9%)
	15%	93.4%(90.9%, 95.3%)	99.7%(99.0%, 99.9%)	99.2%(98.0%, 99.8%)	99.8%(98.5%, 100%)	96.6%(94.0%, 98.3%)	99.6%(99.1%, 99.9%)
	20%	95.3%(93.4%, 96.7%)	99.6%(98.6%, 99.9%)	99.4%(98.6%, 99.8%)	99.7%(97.9%, 100%)	97.6%(95.7%, 98.8%)	99.5%(98.7%, 99.8%)
	25%	96.4%(94.9%, 97.5%)	99.5%(98.2%, 99.9%)	99.6%(98.9%, 99.9%)	99.6%(97.3%, 100%)	98.2%(96.7%, 99.1%)	99.3%(98.2%, 99.7%)
Endocervical	1%	55.8%(44.5%, 66.7%)	99.9%(99.9%, 100%)	96.0%(80.8%, 99.3%)	100%(99.8%, 100%)
	2%	71.9%(61.8%, 80.2%)	99.9%(99.8%, 99.9%)	98.0%(89.5%, 99.6%)	99.9%(99.7%, 100%)
	5%	86.8%(80.7%, 91.2%)	99.7%(99.4%, 99.9%)	99.2%(95.6%, 99.9%)	99.8%(99.2%, 99.9%)
	10%	93.3%(89.8%, 95.7%)	99.4%(98.8%, 99.7%)	99.6%(97.9%, 99.9%)	99.5%(98.3%, 99.9%)
	15%	95.7%(93.3%, 97.2%)	99.0%(98.1%, 99.5%)	99.8%(98.7%, 100%)	99.2%(97.3%, 99.8%)
	20%	96.9%(95.2%, 98.0%)	98.6%(97.3%, 99.3%)	99.8%(99.0%, 100%)	98.9%(96.3%, 99.7%)
	25%	97.7%(96.4%, 98.5%)	98.2%(96.5%, 99.1%)	99.9%(99.3%, 100%)	98.5%(95.1%, 99.6%)
LBCPreservCyt	1%	81.5%(65.2%, 91.1%)	99.9%(99.9%, 100%)	95.8%(80.1%, 99.2%)	99.9%(99.8%, 100%)
	2%	89.9%(79.1%, 95.4%)	99.9%(99.7%, 99.9%)	97.9%(89.0%, 99.6%)	99.9%(99.6%, 99.9%)
	5%	95.8%(90.7%, 98.2%)	99.6%(99.3%, 99.8%)	99.2%(95.4%, 99.9%)	99.6%(99.0%, 99.9%)
	10%	98.0%(95.4%, 99.1%)	99.2%(98.5%, 99.6%)	99.6%(97.8%, 99.9%)	99.2%(97.9%, 99.7%)
	15%	98.7%(97.0%, 99.4%)	98.7%(97.7%, 99.3%)	99.7%(98.6%, 100%)	98.8%(96.8%, 99.6%)
	20%	99.1%(97.9%, 99.6%)	98.2%(96.8%, 99.0%)	99.8%(99.0%, 100%)	98.2%(95.5%, 99.4%)
	25%	99.3%(98.4%, 99.7%)	97.6%(95.8%, 98.7%)	99.9%(99.3%, 100%)	97.7%(94.0%, 99.2%)
Urine	1%	61.6%(42.5%, 77.8%)	100%(99.9%, 100%)	91.1%(64.4%, 98.3%)	100%(100%, 100%)	78.3%(55.1%, 91.4%)	100%(99.9%, 100%)
	2%	76.5%(59.9%, 87.6%)	99.9%(99.8%, 100%)	95.4%(78.5%, 99.2%)	100.0%(99.9%, 100%)	87.9%(71.3%, 95.5%)	100%(99.8%, 100%)
	5%	89.3%(79.4%, 94.8%)	99.8%(99.6%, 99.9%)	98.2%(90.4%, 99.7%)	100%(99.8%, 100%)	94.9%(86.5%, 98.2%)	99.9%(99.4%, 100%)
	10%	94.6%(89.1%, 97.5%)	99.6%(99.2%, 99.8%)	99.1%(95.2%, 99.8%)	99.9%(99.5%, 100%)	97.5%(93.1%, 99.1%)	99.8%(98.8%, 100%)
	15%	96.6%(92.8%, 98.4%)	99.4%(98.7%, 99.8%)	99.4%(96.9%, 99.9%)	99.9%(99.2%, 100%)	98.4%(95.5%, 99.5%)	99.6%(98.1%, 99.9%)
	20%	97.5%(94.8%, 98.9%)	99.2%(98.2%, 99.6%)	99.6%(97.8%, 99.9%)	99.8%(98.9%, 100%)	98.9%(96.8%, 99.6%)	99.5%(97.3%, 99.9%)
	25%	98.1%(96.1%, 99.1%)	98.9%(97.6%, 99.5%)	99.7%(98.4%, 99.9%)	99.7%(98.5%, 100%)	99.2%(97.6%, 99.7%)	99.3%(96.5%, 99.9%)

Table 13: Hypothetical PPV and NPV for BD MAX CTGCTV2

ª The sensitivity and specificity estimates for the patient- and clinician-collected vaginal swabs are similar; the PPV and NPV for vaginal swabs was calculated based on the averages of those estimates.

Regulation Number and Section

§ 866.3860

Trichomonas vaginalis nucleic acid assay.(a)
Identification. ATrichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused byTrichomonas vaginalis .(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection ofTrichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.