Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on nucleic acid detection and hybridization techniques, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No
This device is an in vitro diagnostic test designed to identify microbial organisms and associated resistance genes in blood cultures. It aids in diagnosis and patient management decisions but does not directly treat or prevent disease.

Diagnostic

Yes

The intended use explicitly states that the device is "a qualitative nucleic acid multiplex in vitro diagnostic test" and that its results "aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical instrument (ePlex Instrument) that performs nucleic acid extraction, amplification, and detection using microfluidics, magnetic beads, and electrowetting on a printed circuit board. This involves significant hardware components and processes, not just software.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "The GenMark ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark's ePlex Instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-positive bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture."

This statement clearly identifies the device as an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The GenMark ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark's ePlex Instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-positive bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture. In addition, the ePlex BCID-GP Panel is capable of detecting a wide variety of gram-negative bacteria (Pan Gram-Negative assay) and several Candida species (Pan Candida assay). The ePlex BCID-GP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain gram-positive organism.

The following bacterial organisms and genes associated with antibiotic resistance are identified using the ePlex BCID-GP Panel: Bacillus cereus group, Bacillus subtilis group, Corynebacterium, Cutibacterium acnes (Propionibacterium acnes), Enterococcus, Enterococcus faecalis, Enterococcus faecium, Lactobacillus, Listeria monocytogenes, Micrococcus, Staphylococcus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae (GBS), Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes (GAS), mecA, mecC, vanA and vanB.

The ePlex BCID-GP Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA and mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease.

The ePlex BCID-GP Panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. These include a broad Pan Gram-Negative assay as well as a Pan Candida assay, which is designed to detect four of the most prevalent Candida species: Candida albicans, Candida glabrata, Candida krusei and Candida parapsilosis.

The detection and identification of specific bacterial and fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the ePlex BCID-GP Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the ePlex BCID-GP Panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by ePlex BCID-GP Panel and for susceptibility testing. differentiation of mixed growth and association of antimicrobial resistance marker genes to a specific organism) and clinical presentation must be taken into consideration in the final diagnosis of blood stream infection.

Product codes

PAM, PEN, PEO

Device Description

The ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel is based on the principles of competitive nucleic acid hybridization using a sandwich assay format, wherein a single-stranded target binds concurrently to a sequence-specific solution-phase signal probe and a solid-phase electrode-bound capture probe. The test employs nucleic acid extraction, target amplification via polymerase chain reaction (PCR) or reverse transcription PCR (RT-PCR) and hybridization of target DNA. In the process, the double-stranded PCR amplicons are digested with exonuclease to generate single-stranded DNA suitable for hybridization.

Nucleic acid extraction from biological samples occurs within the cartridge via cell lysis, nucleic acid capture onto magnetic beads, and release for amplification. The nucleic acid extraction is processed through microfluidic liquid handling. Once the nucleic acid targets are captured and inhibitors are washed away, the magnetic particles are delivered to the electrowetting environment on the printed circuit board (PCB) and the targets are eluted from the particles and amplified.

During hybridization, the single-stranded target DNA binds to a complementary, single-stranded capture probe immobilized on the working gold electrode surface. Single-stranded signal probes (labeled with electrochemically active ferrocenes) bind to specific target sequence / region adjacent to the capture probe. Simultaneous hybridization of target to signal probes and capture probe is detected by alternating current voltammetry (ACV). Each working electrode on the array contains specific capture probes, and sequential analysis of each electrode allows detection of multiple analyte targets.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Blood culture samples

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Clinical performance was evaluated in positive blood culture samples prospectively and retrospectively collected.
Prospective samples: collected at 7 clinical sites in 2 phases.

Phase 1: June 2014 through July 2016, 400 samples were prospectively collected and frozen. 8 of these samples were withdrawn (5 due to patient already enrolled, 1 collected outside timeframe, 1 not viable on subculture, 1 from autopsy). Total of 392 evaluable samples.
Phase 2: January through February 2018, 319 samples were prospectively collected and tested fresh (never frozen). Total of 319 evaluable samples.
Total prospective evaluable samples: 711 (312 fresh, 399 frozen).
Retrospective samples: 586 samples were collected retrospectively, and all 586 were evaluable.
Contrived samples: 565 contrived samples were evaluated. These were prepared by spiking an isolate into a blood culture bottle and growing until flagged positive by a continuously monitoring blood culture system. Samples were removed within 8 hours of positivity and stored frozen until testing.

Comparator Method: The performance of the ePlex BCID-GP Panel was compared to standard laboratory procedures, including traditional and automated culture, MALDI-TOF IVD, and microbiological and biochemical techniques for organism identification. For samples with Corynebacterium, Staphylococcus epidermidis, Staphylococcus hominis, or Candida parapsilosis identified by standard laboratory procedures, confirmation was done using analytically validated PCR assays followed by bi-directional sequencing or 16S sequencing. For antibiotic resistance genes (mecA, mecC, vanA, vanB), the ePlex BCID-GP Panel was compared to analytically validated qPCR amplification assays followed by bi-directional sequencing in samples with an associated organism identified (i.e., Staphylococcus, Enterococcus).

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

Study Type: Clinical Performance and Analytical Performance (Limit of Detection, Analytical Reactivity (Inclusivity), Analytical Specificity (Cross-Reactivity and Exclusivity), Bottle Positivity, Reproducibility, Interfering Substances and Sample Matrix Equivalency, Carryover and Cross-Contamination, Competitive Inhibition Study). MRMC and AUC not found.

Clinical Performance:

Sample Size: 711 prospective samples (312 fresh, 399 frozen), 586 retrospective samples, and 565 contrived samples. Total evaluable samples for clinical performance were 1297 (prospective + retrospective samples) for individual analytes, plus 565 contrived samples (where applicable).
Key Results:
- Sensitivity/Positive Percent Agreement (PPA): Ranges from 0.0% to 100% depending on the target and sample type. Most targets show high PPA in combined prospective/retrospective samples, generally above 90%, with some exceptions (e.g., Corynebacterium at 78.4%, Cutibacterium acnes at 90.0%). Contrived samples generally show 100% PPA.
- Specificity/Negative Percent Agreement (NPA): Generally very high, mostly 100% for many targets across all sample types, reflecting low false positive rates. When not 100%, it is still very high (e.g., Staphylococcus at 98.5%, Enterococcus faecium at 99.4%).
- Co-detections: In 1297 clinical samples, 103 bacterial co-detections were identified by the ePlex BCID-GP Panel.
  - Prospective samples: 5.3% double detections, 0.1% triple detections.
  - Retrospective samples: 9.6% co-detections, 1.4% triple detections.

Analytical Performance:

Limit of Detection (LoD): LoD was identified and verified for each assay using at least two quantified reference strains in simulated blood culture sample matrix. LoD concentrations range from 1 x 10^4 CFU/mL to 1 x 10^8 CFU/mL for various organisms.
Analytical Reactivity (Inclusivity): 459 strains/isolates were evaluated. Most strains were detected successfully at 1 x 10^6 CFU/mL or less for bacteria, and 1 x 10^6 CFU/mL for fungi. Some required higher concentrations for detection.
Analytical Specificity (Cross-Reactivity and Exclusivity): 3 organisms showed cross-reactivity: Burkholderia cepacia with Corynebacterium assay (>=1x10^7 CFU/mL), unspeciated Rhodococcus strain (ATCC 49988) with Micrococcus assay (>=1x10^7 CFU/mL), and Bacillus badius with Bacillus subtilis group assay (7 x 10^7 CFU/mL). No cross-reactivity was observed for on-panel gram-positive organisms.
Bottle Positivity: Estimated bottle positivity concentrations are equivalent to or greater than the established LoD for each assay.
Reproducibility: High level of agreement with expected results was demonstrated across three sites, two operators, and three cartridge lots. Most targets showed 100% agreement. Cutibacterium acnes showed lower agreement at lower concentrations (93.5% at 4.4x10^7 CFU/mL, 96.3% at 1.1x10^8 CFU/mL), which was expected due to analyte concentration relative to LoD.
Interfering Substances and Sample Matrix Equivalency: 18 potentially interfering substances were tested, and none were found to inhibit the ePlex BCID-GP Panel at clinically relevant concentrations. Of 13 bottle types, 11 showed no interference. One lot of BACTEC™ Plus Anaerobic bottles showed false positives for Pan Gram-Negative. The BacT/ALERT® FN Plus bottle type showed lower sensitivity for some targets (Pan Gram-Negative and E. faecium with vanA).
Carryover and Cross-Contamination: No false positives were detected in negative runs over 120 runs, indicating no carryover or cross-contamination.
Competitive Inhibition Study: No competitive inhibition was observed in any replicates of the twelve testing conditions in dual infection mixes.

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

Sensitivity/Positive Percent Agreement (PPA):
- Bacillus cereus group: 91.7% (64.6-98.5) overall clinical, 100% (92.3-100) contrived.
- Bacillus subtilis group: 100% (34.2-100) overall clinical, 100% (92.9-100) contrived.
- Corynebacterium: 78.4% (65.4-87.5) overall clinical, 100% (83.9-100) contrived.
- Cutibacterium acnes: 90.0% (69.9-97.2) overall clinical, 96.2% (81.1-99.3) contrived.
- Enterococcus: 96.2% (92.6-98.0) overall clinical, 100% (97.0-100) contrived.
- Enterococcus faecalis: 94.2% (89.1-97.1) overall clinical, 100% (93.1-100) contrived.
- Enterococcus faecium: 96.9% (89.5-99.2) overall clinical, 100% (94.0-100) contrived.
- Lactobacillus: 100% (77.2-100) overall clinical, 97.0% (84.7-99.5) contrived.
- Listeria: 100% (34.2-100) overall clinical, 98.7% (92.8-99.8) contrived.
- Listeria monocytogenes: 100% (34.2-100) overall clinical, 100% (92.3-100) contrived.
- Micrococcus: 88.6% (76.0-95.0) overall clinical, 100% (87.5-100) contrived.
- Staphylococcus: 97.7% (96.2-98.6) overall clinical, 100% (96.5-100) contrived.
- Staphylococcus aureus: 96.9% (94.2-98.4) overall clinical, 100% (93.9-100) contrived.
- Staphylococcus epidermidis: 93.1% (88.0-96.1) overall clinical, 100% (20.7-100) contrived.
- Staphylococcus lugdunensis: 100% (61.0-100) overall clinical, 100% (92.1-100) contrived.
- Streptococcus: 96.8% (94.1-98.3) overall clinical, 100% (93.7-100) contrived.
- Streptococcus agalactiae: 95.8% (86.0-98.8) overall clinical, 100% (67.6-100) contrived.
- Streptococcus anginosus group: 93.3% (82.1-97.7) overall clinical, 100% (85.7-100) contrived.
- Streptococcus pneumoniae: 95.7% (88.0-98.5) overall clinical, 0/0 contrived.
- Streptococcus pyogenes: 96.4% (82.3-99.4) overall clinical, 100% (87.1-100) contrived.
- mecA (Staphylococcus): 97.1% (95.0-98.3) overall clinical, 100% (74.1-100) contrived.
- mecA (S. aureus): 97.9% (94.8-99.2) overall clinical, 100% (72.2-100) contrived.
- mecA (S. epidermidis): 98.2% (93.6-99.5) overall clinical, 100% (20.7-100) contrived.
- mecA (S. lugdunensis): 100% (20.7-100) overall clinical, 0/0 contrived.
- mecC (Staphylococcus): 0/0 overall clinical, 100% (92.7-100) contrived.
- vanA (Enterococcus): 93.8% (85.2-97.6) overall clinical, 100% (94.0-100) contrived.
- vanA (E. faecalis): 80.0% (54.8-93.0) overall clinical, 100% (72.2-100) contrived.
- vanA (E. faecium): 100% (93.0-100) overall clinical, 100% (92.9-100) contrived.
- vanB (Enterococcus): 100% (20.7-100) overall clinical, 100% (93.1-100) contrived.
- vanB (E. faecalis): 100% (20.7-100) overall clinical, 100% (91.6-100) contrived.
- vanB (E. faecium): 0/0 overall clinical, 100% (72.2-100) contrived.
- Pan Candida: 77.8% (45.3-93.7) overall clinical, 93.8% (87.0-97.1) non-intended use samples.
- Pan Gram-Negative: 83.7% (70.0-91.9) overall clinical, 97.1% (94.8-98.4) non-intended use samples.
Specificity/Negative Percent Agreement (NPA):
- Bacillus cereus group: 100% (99.8-100) overall clinical, 100% (99.3-100) contrived.
- Bacillus subtilis group: 100% (99.7-100) overall clinical, 100% (99.3-100) contrived.
- Corynebacterium: 99.8% (99.4-100) overall clinical, 100% (99.3-100) contrived.
- Cutibacterium acnes: 99.8% (99.4-100) overall clinical, 100% (99.3-100) contrived.
- Enterococcus: 99.9% (99.5-100) overall clinical, 100% (99.1-100) contrived.
- Enterococcus faecalis: 100% (99.7-100) overall clinical, 100% (99.3-100) contrived.
- Enterococcus faecium: 99.4% (98.7-99.7) overall clinical, 100% (99.2-100) contrived.
- Lactobacillus: 99.8% (99.4-100) overall clinical, 100% (99.3-100) contrived.
- Listeria: 99.9% (99.6-100) overall clinical, 100% (99.2-100) contrived.
- Listeria monocytogenes: 100% (99.7-100) overall clinical, 100% (99.3-100) contrived.
- Micrococcus: 99.9% (99.5-100) overall clinical, 100% (99.3-100) contrived.
- Staphylococcus: 98.5% (97.2-99.2) overall clinical, 100% (99.2-100) contrived.
- Staphylococcus aureus: 99.4% (98.6-99.7) overall clinical, 100% (99.2-100) contrived.
- Staphylococcus epidermidis: 98.2% (97.2-98.8) overall clinical, 100% (99.3-100) contrived.
- Staphylococcus lugdunensis: 99.8% (99.4-100) overall clinical, 99.8% (98.9-100) contrived.
- Streptococcus: 99.1% (98.3-99.5) overall clinical, 100% (99.2-100) contrived.
- Streptococcus agalactiae: 99.8% (99.4-100) overall clinical, 100% (99.3-100) contrived.
- Streptococcus anginosus group: 99.8% (99.3-99.9) overall clinical, 100% (99.3-100) contrived.
- Streptococcus pneumoniae: 99.8% (99.4-100) overall clinical, 100% (99.3-100) contrived.
- Streptococcus pyogenes: 100% (99.7-100) overall clinical, 100% (99.3-100) contrived.
- mecA (Staphylococcus): 95.3% (91.8-97.4) overall clinical, 100% (96.1-100) contrived.
- mecA (S. aureus): 95.9% (89.9-98.4) overall clinical, 100% (92.7-100) contrived.
- mecA (S. epidermidis): 92.0% (81.2-96.8) overall clinical, 0/0 contrived.
- mecA (S. lugdunensis): 100% (56.6-100) overall clinical, 100% (92.1-100) contrived.
- mecC (Staphylococcus): 100% (99.4-100) overall clinical, 100% (93.6-100) contrived.
- vanA (Enterococcus): 98.6% (95.0-99.6) overall clinical, 100% (94.5-100) contrived.
- vanA (E. faecalis): 100% (97.0-100) overall clinical, 100% (91.6-100) contrived.
- vanA (E. faecium): 85.7% (60.1-96.0) overall clinical, 100% (72.2-100) contrived.
- vanB (Enterococcus): 100% (98.2-100) overall clinical, 100% (95.1-100) contrived.
- vanB (E. faecalis): 100% (97.3-100) overall clinical, 100% (72.2-100) contrived.
- vanB (E. faecium): 100% (94.4-100) overall clinical, 100% (92.9-100) contrived.
- Pan Candida: 99.8% (99.0-100) overall clinical, 99.7% (98.5-100) non-intended use samples.
- Pan Gram-Negative: 99.4% (98.4-99.8) overall clinical, 99.0% (94.8-99.8) non-intended use samples.
Overall Validity Rate (from Instrument Performance): 99.9% (99.7%-100%) after repeat testing.

Predicate Device(s)

K130914

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

(a)
Identification. A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.(b)
Classification. Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).

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.

December 20, 2018

GenMark Diagnostics, Incorporated Alan Maderazo VP, Quality, Regulatory & Clinical Affairs 5964 La Place Court Carlsbad, California 92008

Re: K181663

Trade/Device Name: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel Regulation Number: 21 CFR 866.3365 Regulation Name: Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures Regulatory Class: Class II Product Code: PAM, PEN, PEO Dated: June 22, 2018 Received: June 25, 2018

Dear Alan Maderazo:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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Indications for Use

510(k) Number (if known) K181663

Device Name

ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel

Indications for Use (Describe)

The GenMark ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark's ePlex Instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-positive bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture. In addition, the ePlex BCID-GP Panel is capable of detecting a wide variety of gram-negative bacteria (Pan Gram-Negative assay) and several Candida species (Pan Candida assay). The ePlex BCID-GP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain gram-positive organism.

The following bacterial organisms and genes associated with antibiotic resistance are identified using the ePlex BCID-GP Panel: Bacillus cereus group, Bacillus subtilis group, Corynebacterium, Cutibacterium acnes (Propionibacterium acnes), Enterococcus, Enterococcus faecalis, Enterococcus faecium, Lactobacillus, Listeria monocytogenes, Micrococcus, Staphylococcus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae (GBS), Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes (GAS), mecA, mecC, vanA and vanB.

The ePlex BCID-GP Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA and mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease.

The ePlex BCID-GP Panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. These include a broad Pan Gram-Negative assay as well as a Pan Candida assay, which is designed to detect four of the most prevalent Candida species: Candida albicans, Candida glabrata, Candida krusei and Candida parapsilosis.

The detection and identification of specific bacterial and fungal nucleic acids from individuals

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exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the ePlex BCID-GP Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the ePlex BCID-GP Panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by ePlex BCID-GP Panel and for susceptibility testing. differentiation of mixed growth and association of antimicrobial resistance marker genes to a specific organism) and clinical presentation must be taken into consideration in the final diagnosis of blood stream infection.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Summary of Safety and Effectiveness

Submitter Information

GenMark Diagnostics, Incorporated Submitter: 5964 La Place Court Carlsbad, CA 92008

Manufacturer: GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008
Establishment Registration Number: 3008632402

| Contact: | Alan Maderazo, Ph.D., RAC
Vice President, Quality, Regulatory and Clinical Affairs |
|--------------------|---------------------------------------------------------------------------------------|
| Phone: | 760-448-4308 |
| Fax: | 760-683-6961 |
| E-mail: | Al.Maderazo@genmarkdx.com |
| Alternate Contact: | Beth Stofka
Sr. Regulatory Affairs Specialist |
| Phone: | 760-579-4778 |
| Fax: | 760-683-6961 |
| E-mail: | Beth.Stofka@genmarkdx.com |
| Date Prepared: | June 22, 2018 |

Name of Device and Classification

Product Name:	ePlex® Blood Culture Identification Gram-Positive (BCID-GP) Panel
Device Classification:	866.3980, Multiplex nucleic acid assay for identification of
microorganisms and resistance markers from positive blood cultures,
Class II
Product Code(s):	PAM, PEN, PEO

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Predicate Device

Predicate:

FilmArray Blood Culture Identification Panel; BioFire Diagnostics; K130914

Device Description

The ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel is based on the principles of competitive nucleic acid hybridization using a sandwich assay format, wherein a single-stranded target binds concurrently to a sequence-specific solution-phase signal probe and a solid-phase electrode-bound capture probe. The test employs nucleic acid extraction, target amplification via polymerase chain reaction (PCR) or reverse transcription PCR (RT-PCR) and hybridization of target DNA. In the process, the double-stranded PCR amplicons are digested with exonuclease to generate single-stranded DNA suitable for hybridization.

Nucleic acid extraction from biological samples occurs within the cartridge via cell lysis, nucleic acid capture onto magnetic beads, and release for amplification. The nucleic acid extraction is processed through microfluidic liquid handling. Once the nucleic acid targets are captured and inhibitors are washed away, the magnetic particles are delivered to the electrowetting environment on the printed circuit board (PCB) and the targets are eluted from the particles and amplified.

During hybridization, the single-stranded target DNA binds to a complementary, single-stranded capture probe immobilized on the working gold electrode surface. Single-stranded signal probes (labeled with electrochemically active ferrocenes) bind to specific target sequence / region adjacent to the capture probe. Simultaneous hybridization of target to signal probes and capture probe is detected by alternating current voltammetry (ACV). Each working electrode on the array contains specific capture probes, and sequential analysis of each electrode allows detection of multiple analyte targets.

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Intended Use/Indications for Use

The GenMark ePlex® Blood Culture Identification Gram-Positive (BCID-GP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on GenMark's ePlex Instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-positive bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture. In addition, the ePlex BCID-GP Panel is capable of detecting a wide variety of gram-negative bacteria (Pan Gram-Negative assay) and several Candida species (Pan Candida assay). The ePlex BCID-GP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain gram-positive organism.

The following bacterial organisms and genes associated with antibiotic resistance are identified using the ePlex BCID-GP Panel: Bacillus cereus group, Bacillus subtilis group, Corynebacterium, Cutibacterium acnes (Propionibacterium acnes), Enterococcus, Enterococcus faecalis, Enterococcus faecium, Lactobacillus, Listeria monocytogenes, Micrococcus, Staphylococcus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus, Streptococcus agalactiae (GBS), Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes (GAS), mecA, mecC, vanA and vanB.

The ePlex BCID-GP Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA and mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease.

The ePlex BCID-GP Panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. These include a broad Pan Gram-Negative assay as well as a Pan Candida assay, which is designed to detect four of the most prevalent Candida species: Candida albicans, Candida glabrata, Candida krusei and Candida parapsilosis.

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The detection and identification of specific bacterial and fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the ePlex BCID-GP Panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the ePlex BCID-GP Panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by ePlex BCID-GP Panel and for susceptibility testing. differentiation of mixed growth and association of antimicrobial resistance marker genes to a specific organism) and clinical presentation must be taken into consideration in the final diagnosis of blood stream infection.

Summary of Technological Characteristics of the Device Compared to the Predicate Device

The GenMark ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel ("Subject Device") and the legally marketed device, FilmArray Blood Culture Identification Gram-Positive Panel, K130914, ("Predicate Device") are described below:

Characteristic	Subject Device	Predicate Device
Product Name	ePlex BCID-GP Panel	FilmArray BCID Panel
Manufacturer	GenMark Diagnostics, Inc.	BioFire Diagnostics, Inc.
Organisms
Detected	Bacillus cereus group Bacillus subtilis group Corynebacterium Cutibacterium acnes (P. acnes) Enterococcus Enterococcus facealis Enterococcus faecium Lactobacillus Listeria Listeria monocytogenes Micrococcus Staphylococcus Staphylococcus aureus Staphylococcus epidermidis	Enterococci, Listeria monocytogenes,
commonly encountered Staphylococci
(including specific differentiation of
Staphylococcus aureus), commonly
encountered Streptococci (with
specific differentiation of
Streptococcus agalactiae,
Streptococcus pneumoniae, and
Streptococcus pyogenes),
Acinetobacter baumannii, commonly
encountered Enterobacteriaceae
(including specific differentiation of
the Enterobacter cloacae complex,
Escherichia coli, Klebsiella oxytoca,
Characteristic	Subject Device	Predicate Device
	Staphylococcus lugdunensis Streptococcus Streptococcus agalactiae (GBS) Streptococcus anginosus group Streptococcus pneumonia Streptococcus pyogenes (GAS) Pan Gram-Negative Pan Candida	Klebsiella pneumoniae, Proteus, and
Serratia marcescens), Haemophilus
influenzae, Neisseria meningitidis
(encapsulated), Pseudomonas
aeruginosa, Candida albicans,
Candida glabrata, Candida krusei,
Candida parapsilosis, and Candida
tropicalis.
Resistance Genes
Detected	Genetic determinants of resistance to
methicillin ( mecA and mecC ) and
vancomycin ( vanA and vanB )	Genetic determinants of resistance to
methicillin ( mecA ), vancomycin
( vanA and vanB ), and carbapenems
( bla KPC)
Indication for
Use	The GenMark BCID-GP panel is
indicated as an aid in the diagnosis of
specific agents of bacteremia. The use
of additional laboratory testing (e.g.
sub-culturing of positive blood cultures
for identification of organisms not
detected by BCID-GP Panel and for
susceptibility testing, differentiation of
mixed growth, and association of
antimicrobial resistance marker genes to
a specific organism) and clinical
presentation must be taken into
consideration in the final diagnosis of
blood stream infection.	FilmArray BCID is indicated as an aid
in the diagnosis of specific agents of
bacteremia and fungemia and results
should be used in conjunction with
other clinical and laboratory findings.
Specimen Type	Gram-Positive Blood Culture	Gram-Positive & Gram-Negative
Blood Culture
Chemistry	Reagents on cartridge include: sample
lysis and nucleic acid extraction, PCR
amplification and hybridization-based
electrochemical detection reagents.	The FilmArray BCID pouch contains
freeze-dried reagents to perform
nucleic acid purification and nested,
multiplex PCR with DNA melt
analysis.
Hardware	GenMark ePlex Instrument & Single
Use Cartridge	FilmArray Instrument and assay pouch
Software
Interface
Result Reporting	GenMark ePlex System Software GenMark ePlex BCID-GP Panel
Software	The FilmArray Software automatically
interprets the results of each DNA
melt curve analysis and combines the
data with the results of the internal
pouch controls to provide a test result
for each organism and antimicrobial
resistance gene on the panel.

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Analysis of the similarities and differences indicate that the devices are substantially equivalent in their intended uses/indications for use, and are generally the same regarding user process, ease

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of use and general operator protocol. Comparison of technological similarities and differences between the proposed device and the predicate do not raise new or different questions of safety and effectiveness, and therefore render the proposed device as substantially equivalent to the predicate device.

Summary of Performance Data

EXPECTED VALUES

A prospective, multicenter clinical study was conducted to evaluate the clinical performance of the ePlex BCID-GP Panel in positive blood culture samples. A total of 711 samples were prospectively collected at 7 clinical sites in 2 phases from patients of all ages and genders. In the first phase from June 2014 through July 2016, 399 samples were prospectively collected and frozen; from January through February 2018, 312 samples were prospectively collected and tested fresh (never frozen). The expected values of individual analytes based on the ePlex BCID-GP Panel results in prospective samples are summarized by age group and by site in Table 1 and Table 2, respectively.

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Table 1: Expected Value by Age Group (Prospective Samples)

| Target (N=711) | Age mecA
Staphylococcus | Prospective (Fresh) | 86/89 | | Prospective (Frozen) | | Prospective (All) | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | | Prospective (Fresh) | | Prospective (Frozen) | mecA
Staphylococcus
aureus | Prospective (All) | 83/86 | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | | Prospective (Fresh) | | Prospective (Frozen) | mecA
Staphylococcus
epidermidis | Prospective (All) | 77/79 | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | mecA
Staphylococcus
lugdunensis | Prospective (Fresh) | 0/0 | --- | | Prospective (Frozen) | | Prospective (All) | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | Target | Sample Type | | | mecC
Staphylococcus | Prospective (Fresh) | | Prospective (Frozen) | | Prospective (All) | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | mecC
Staphylococcus
aureus | Prospective (Fresh) | 0/0 | | Prospective (Frozen) | | Prospective (All) | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | mecC
Staphylococcus
epidermidis | Prospective (Fresh) | 0/0 | | Prospective (Frozen) | | Prospective (All) | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | mecC
Staphylococcus
lugdunensis | Prospective (Fresh) | 0/0 | | Prospective (Frozen) | | Prospective (All) | | Retrospective | | Prospective/Retrospective | | Contrived | | Overall | All Ages
| 96.6 (90.6-98.8) | 85/93 | 91.4 (83.9-95.6) |
| 164/171 | 95.9 (91.8-98.0) | 101/103 | 98.1 (93.2-99.5) |
| 250/260 | 96.2 (93.1-97.9) | 186/196 | 94.9 (90.9-97.2) |
| 151/153 | 98.7 (95.4-99.6) | 37/38 | 97.4 (86.5-99.5) |
| 401/413 | 97.1 (95.0-98.3) | 223/234^ | 95.3 (91.8-97.4) |
| 11/11 | 100 (74.1-100) | 94/94 | 100 (96.1-100) |
| 412/424 | 97.2 (95.1-98.4) | 317/328 | 96.6 (94.1-98.1) |
| 27/28 | 96.4 (82.3-99.4) | 34/37 | 91.9 (78.7-97.2) |
| 56/58 | 96.6 (88.3-99.0) | 43/43 | 100 (91.8-100) |
| 96.5 (90.2-98.8) | 77/80 | 96.3 (89.5-98.7) |
| 107/108 | 99.1 (94.9-99.8) | 16/17 | 94.1 (73.0-99.0) |
| 190/194 | 97.9 (94.8-99.2) | 93/97 | 95.9 (89.9-98.4) |
| 10/10 | 100 (72.2-100) | 49/49 | 100 (92.7-100) |
| 200/204 | 98.0 (95.1-99.2) | 142/146 | 97.3 (93.2-98.9) |
| 36/36 | 100 (90.4-100) | 24/27 | 88.9 (71.9-96.1) |
| 41/43 | 95.3 (84.5-98.7) | 15/15 | 100 (79.6-100) |
| 97.5 (91.2-99.3) | 39/42 | 92.9 (81.0-97.5) |
| 30/30 | 100 (88.6-100) | 43/49 | 87.5 (52.9-97.8) |
| 107/109 | 98.2 (93.6-99.5) | 46/50 | 92.0 (81.2-96.8) |
| 1/1 | 100 (20.7-100) | 0/0 | --- |
| 108/110 | 98.2 (93.6-99.5) | 46/50 | 92.0 (81.2-96.8) |
| 1/1 | 100 (20.7-100) |
| 0/0 | --- | 1/1 | 100 (20.7-100) |
| 0/0 | --- | 2/2 | 100 (34.2-100) |
| 1/1 | 100 (20.7-100) | 3/3 | 100 (43.9-100) |
| 1/1 | 100 (20.7-100) | 5/5 | 100 (56.6-100) |
| 0/0 | --- | 45/45 | 100 (92.1-100) |
| 1/1 | 100 (20.7-100) | 50/50 | 100 (92.9-100) |
| Sensitivity/PPA | | Specificity/NPA | |
| TP/TP+FN | % (95% CI) | TN/TN+FP | % (95% CI) |
| 0/0 | --- | 182/182 | 100 (97.9-100) |
| 0/0 | --- | 274/274 | 100 (98.6-100) |
| 0/0 | --- | 456/456 | 100 (99.2-100) |
| 0/0 | --- | 191/191 | 100 (98.0-100) |
| 0/0 | --- | 647/647 | 100 (99.4-100) |
| 49/49 | 100 (92.7-100) | 56/56 | 100 (93.6-100) |
| 49/49 | 100 (92.7-100) | 703/703 | 100 (99.5-100) |
| --- | 65/65 | 100 (94.4-100) |
| 0/0 | --- | 101/101 | 100 (96.3-100) |
| 0/0 | --- | 166/166 | 100 (97.7-100) |
| 0/0 | --- | 125/125 | 100 (97.0-100) |
| 0/0 | --- | 291/291 | 100 (98.7-100) |
| 49/49 | 100 (92.7-100) | 10/10 | 100 (72.2-100) |
| 49/49 | 100 (92.7-100) | 301/301 | 100 (98.7-100) |
| --- | 63/63 | 100 (94.3-100) |
| 0/0 | --- | 58/58 | 100 (93.8-100) |
| 0/0 | --- | 121/121 | 100 (96.9-100) |
| 0/0 | --- | 38/38 | 100 (90.8-100) |
| 0/0 | --- | 159/159 | 100 (97.6-100) |
| 0/0 | --- | 1/1 | 100 (20.7-100) |
| 0/0 | --- | 160/160 | 100 (97.7-100) |
| --- | 1/1 | 100 (20.7-100) |
| 0/0 | --- | 1/1 | 100 (20.7-100) |
| 0/0 | --- | 2/2 | 100 (34.2-100) |
| 0/0 | --- | 4/4 | 100 (51.0-100) |
| 0/0 | --- | 6/6 | 100 (61.0-100) |
| 0/0 | --- | 45/45 | 100 (92.1-100) |
| 0/0 | --- | 51/51 | 100 (93.0-100) |

mecA was detected in 4 of the 7 false positive samples that were tested with an FDA-cleared multiplex assay. A.

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Table 27: Clinical Performance for mecC

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Target	Sample Type	Sensitivity/PPA		Specificity/NPA
		TP/TP+FN	% (95% CI)	TN/TN+FP	% (95% CI)
vanA
Enterococcus	Prospective (Fresh)	0/0	---	24/25	96.0 (80.5-99.3)
	Prospective (Frozen)	8/8	100 (67.6-100)	28/28	100 (87.9-100)
	Prospective (All)	8/8	100 (67.6-100)	52/53	98.1 (90.1-99.7)
	Retrospective	53/57	93.0 (83.3-97.2)	89/90	98.9 (94.0-99.8)
	Prospective/Retrospective	61/65A	93.8 (85.2-97.6)	141/143B	98.6 (95.0-99.6)
	Contrived	60/60	100 (94.0-100)	66/66	100 (94.5-100)
	Overall	121/125	96.8 (92.1-98.7)	207/209	99.0 (96.6-99.7)
	Prospective (Fresh)	0/0	---	21/21	100 (84.5-100)		Prospective (Frozen)	1/1	100 (20.7-100)	27/27	100 (87.5-100)		Prospective (All)	1/1	100 (20.7-100)	48/48	100 (92.6-100)	vanA
Enterococcus faecalis	Retrospective	11/14	78.6 (52.4-92.4)	76/76	100 (95.2-100)	Prospective/Retrospective	12/15	80.0 (54.8-93.0)	124/124	100 (97.0-100)	Contrived	10/10	100 (72.2-100)	42/42	100 (91.6-100)	Overall	22/25	88.0 (70.0-95.8)	166/166	100 (97.7-100)	Prospective (Fresh)	0/0	---	2/3	66.7 (20.8-93.9)	Prospective (Frozen)	7/7	100 (64.6-100)	2/2	100 (34.2-100)	Prospective (All)	7/7	100 (64.6-100)	4/5	80.0 (37.6-96.4)	vanA
Enterococcus faecium	Retrospective	44/44	100 (92.0-100)	8/9	88.9 (56.5-98.0)	Prospective/Retrospective	51/51	100 (93.0-100)	12/14	85.7 (60.1-96.0)	Contrived	50/50	100 (92.9-100)	10/10	100 (72.2-100)	Overall	101/101	100 (96.3-100)	22/24	91.7 (74.2-97.7)
	Prospective (Fresh)	0/0	---	21/21	100 (84.5-100)
	Prospective (Frozen)	1/1	100 (20.7-100)	27/27	100 (87.5-100)
	Prospective (All)	1/1	100 (20.7-100)	48/48	100 (92.6-100)
vanA
Enterococcus faecalis	Retrospective	11/14	78.6 (52.4-92.4)	76/76	100 (95.2-100)
	Prospective/Retrospective	12/15	80.0 (54.8-93.0)	124/124	100 (97.0-100)
	Contrived	10/10	100 (72.2-100)	42/42	100 (91.6-100)
	Overall	22/25	88.0 (70.0-95.8)	166/166	100 (97.7-100)
	Prospective (Fresh)	0/0	---	2/3	66.7 (20.8-93.9)
	Prospective (Frozen)	7/7	100 (64.6-100)	2/2	100 (34.2-100)
	Prospective (All)	7/7	100 (64.6-100)	4/5	80.0 (37.6-96.4)
vanA
Enterococcus faecium	Retrospective	44/44	100 (92.0-100)	8/9	88.9 (56.5-98.0)
	Prospective/Retrospective	51/51	100 (93.0-100)	12/14	85.7 (60.1-96.0)
	Contrived	50/50	100 (92.9-100)	10/10	100 (72.2-100)
	Overall	101/101	100 (96.3-100)	22/24	91.7 (74.2-97.7)

Table 28: Clinical Performance for vanA

A. vanA was not detected in 1 false negative sample using an FDA-cleared multiplex assay.

B. vanA was detected in the 1 false positive sample that was tested using an FDA-cleared multiplex assay.

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Target	Sample Type	Sensitivity/PPA		Specificity/NPA
		TP/TP+FN	% (95% CI)	TN/TN+FP	% (95% CI)
vanB
Enterococcus	Prospective (Fresh)	0/0	---	25/25	100 (86.7-100)
	Prospective (Frozen)	0/0	---	36/36	100 (90.4-100)
	Prospective (All)	0/0	---	61/61	100 (94.1-100)
	Retrospective	1/1	100 (20.7-100)	146/146	100 (97.4-100)
	Prospective/Retrospective	1/1	100 (20.7-100)	207/207	100 (98.2-100)
	Contrived	52/52	100 (93.1-100)	74/74	100 (95.1-100)
	Overall	53/53	100 (93.2-100)	281/281	100 (98.7-100)
vanB
Enterococcus faecalis	Prospective (Fresh)	0/0	---	21/21	100 (84.5-100)
	Prospective (Frozen)	0/0	---	28/28	100 (87.9-100)
	Prospective (All)	0/0	---	49/49	100 (92.7-100)
	Retrospective	1/1	100 (20.7-100)	89/89	100 (95.9-100)
	Prospective/Retrospective	1/1	100 (20.7-100)	138/138	100 (97.3-100)
	Contrived	42/42	100 (91.6-100)	10/10	100 (72.2-100)
	Overall	43/43	100 (91.8-100)	148/148	100 (97.5-100)
vanB
Enterococcus faecium	Prospective (Fresh)	0/0	---	3/3	100 (43.9-100)
	Prospective (Frozen)	0/0	---	9/9	100 (70.1-100)
	Prospective (All)	0/0	---	12/12	100 (75.8-100)
	Retrospective	0/0	---	53/53	100 (93.2-100)
	Prospective/Retrospective	0/0	---	65/65	100 (94.4-100)
	Contrived	10/10	100 (72.2-100)	50/50	100 (92.9-100)
	Overall	10/10	100 (72.2-100)	115/115	100 (96.8-100)

Table 29: Clinical Performance for vanB

Pan Targets

In addition to the evaluable prospective and retrospective samples that contain gram-positive organisms, the clinical performance of the Pan Candida and Pan Gram-Negative targets was evaluated by testing an additional 480 non-intended use retrospective samples with gramnegative or fungal organisms; these are denoted as Retrospective (Non-Intended Use) samples. Results from those samples are summarized in Table 30.

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| Target | Sample Type | TP/TP+FN | Sensitivity/PPA
% (95% CI) | TN/TN+FP | Specificity/NPA
% (95% CI) |
|-------------------|----------------------------------|----------|-------------------------------|----------|-------------------------------|
| Pan Candida | Prospective (Fresh) | 0/0 | --- | 312/312 | 100 (98.8-100) |
| | Prospective (Frozen) | 0/0 | --- | 399/399 | 100 (99.0-100) |
| | Prospective (All) | 0/0 | --- | 711/711 | 100 (99.5-100) |
| | Retrospective | 7/9 | 77.8 (45.3-93.7) | 576/577 | 99.8 (99.0-100) |
| | Retrospective (Non-Intended Use) | 90/96 | 93.8 (87.0-97.1) | 383/384A | 99.7 (98.5-100) |
| | Contrived | 0/0 | --- | 565/565 | 100 (99.3-100) |
| Pan Gram-Negative | Prospective (Fresh) | 10/11 | 90.9 (62.3-98.4) | 299/301 | 99.3 (97.6-99.8) |
| | Prospective (Frozen) | 12/12 | 100 (75.8-100) | 386/387 | 99.7 (98.6-100) |
| | Prospective (All) | 22/23 | 95.7 (79.0-99.2) | 685/688B | 99.6 (98.7-99.9) |
| | Retrospective | 36/43 | 83.7 (70.0-91.9) | 540/543C | 99.4 (98.4-99.8) |
| | Retrospective (Non-Intended Use) | 364/375 | 97.1 (94.8-98.4) | 104/105 | 99.0 (94.8-99.8) |
| | Contrived | 0/0 | --- | 565/565 | 100 (99.3-100) |

Table 30: Clinical Performance for Pan Targets

A. Candida glabrata was detected in 1/1 false positive samples using PCR/sequencing.

A gram-negative organism, Klebsiella pneumoniae, was detected in 1/3 false positive samples using PCR sequencing. B.

C. A gram-negative organism, Escherichia coli, was detected in 1/3 false positive samples using PCR/sequencing.

Table 31: Contrived Sample Summary

| Target | Organism | Strain | Independent Contrived
Samples Tested |
|----------------------------|-----------------------------------------|-------------------------------------------|-----------------------------------------|
| Bacillus cereus
group | Bacillus cereus | ATCC 10876 | 11 |
| | | ATCC 21769 | 10 |
| | | ATCC 31430 | 9 |
| | | ATCC 53522 | 10 |
| | Bacillus thuringiensis | ATCC 33679 | 1 |
| | | ATCC 10792 | 2 |
| | | ATCC 55173 | 3 |
| | Bacillus cereus group total | | 46 |
| Bacillus subtilis
group | Bacillus amyloliquefaciens | ATCC 23350 | 3 |
| | | ATCC 23845 | 4 |
| | | ATCC 53495 | 3 |
| | Bacillus atrophaeus | ATCC 51189 | 4 |
| | | ATCC 6455 | 3 |
| | | ATCC 6537 | 4 |
| | Bacillus licheniformis | ATCC 21039 | 3 |
| | | ATCC 21667 | 3 |
| | | ATCC 53926 | 4 |
| | Bacillus subtilis | ATCC 15040 | 5 |
| | | ATCC 15561 | 8 |
| | | ATCC 55614 | 6 |
| | Bacillus subtilis group total | | 50 |
| Corynebacterium | Corynebacterium coyleae | ATCC 700219 | 7 |
| | Corynebacterium falsenii | ATCC BAA-596 | 9 |
| | Corynebacterium striatum | ATCC BAA-1293 | 4 |
| | Corynebacterium total | | 20 |
| Target | Organism | Strain | Independent Contrived
Samples Tested |
| Enterococcus | Enterococcus faecalis, vanA | JMI 876745 | 10 |
| | | ATCC 51299 | 11 |
| | | ATCC 51575 | 11 |
| | Enterococcus faecalis, vanB | ATCC 700802 | 10 |
| | | ATCC BAA-2365 | 10 |
| | | ATCC 51559 | 4 |
| | Enterococcus faecium, vanA | ATCC 700221 | 3 |
| | | ATCC BAA-2316 | 5 |
| | | ATCC BAA-2317 | 3 |
| | | ATCC BAA-2318 | 5 |
| | | ATCC BAA-2319 | 5 |
| | | ATCC BAA-2320 | 3 |
| | | LMC 002867 | 3 |
| | | LMC 003921 | 4 |
| | | LMC 032261 | 4 |
| | | LMC 055971 | 3 |
| | | LMC 103676 | 5 |
| | | LMC 104266 | 3 |
| | Enterococcus faecium, vanB | ATCC 51858 | 10 |
| | Enterococcus flavescens | ATCC 49996 | 3 |
| | Enterococcus gallinarum | ATCC 49610
ATCC 700425 | 1
3 |
| | Enterococcus hirae | ATCC 10541 | 1 |
| | Enterococcus malodoratus | ATCC 43197 | 3 |
| | Enterococcus raffinosus | ATCC 49464 | 2 |
| | Enterococcus saccharolyticus | ATCC 43076 | 1 |
| | Enterococcus total | | 126 |
| Lactobacillus | Lactobacillus casei | ATCC 25598 | 2 |
| | | ATCC 334 | 6 |
| | | ATCC 39392 | 4 |
| | | 148-260 * | 3 |
| | Lactobacillus paracasei | ATCC 27092 | 2 |
| | | ATCC BAA-52 | 6 |
| | | ATCC 39595 | 3 |
| | | ATCC 53103 | 5 |
| | Lactobacillus rhamnosus | ATCC 55915 | 2 |
| | Lactobacillus total | | 33 |
| Listeria | Listeria innocua | ATCC 33090
NCTC 11288 | 4
5 |
| | Listeria ivanovii | ATCC 19119
ATCC 700402
ATCC BAA-139 | 2
4
4 |
| | Listeria monocytogenes | ATCC 13932 | 5 |
| | | ATCC 19111 | 3 |
| | | ATCC 19112 | 4 |
| | | ATCC 19114 | 5 |
| | | ATCC 19116 | 5 |
| | | ATCC 19117 | 5 |
| | | ATCC 19118 | 5 |
| | | ATCC 7644 | 5 |
| | | ATCC BAA-751 | 5 |
| | | NCTC 10890 | 4 |
| Target | Organism | Strain | Independent Contrived
Samples Tested |
| | Listeria seeligeri | ATCC 35967 | 5 |
| | Listeria welshimeri | ATCC 35897 | 5 |
| | Listeria total | | 75 |
| Micrococcus | Micrococcus luteus | ATCC 10240 | 3 |
| | | ATCC 19212 | 3 |
| | | ATCC 400 | 3 |
| | | ATCC 4698 | 3 |
| | | ATCC 49732 | 3 |
| | | ATCC 53598 | 4 |
| | Micrococcus lylae | ATCC 27566 | 4 |
| | Micrococcus yunnanensis | ATCC 7468 | 4 |
| | Micrococcus total | | 27 |
| Cutibacterium
acnes | Cutibacterium acnes | ATCC 11827 | 8 |
| | | ATCC 11828 | 6 |
| | | ATCC 33179 | 4 |
| | | ATCC 6919 | 8 |
| | Cutibacterium acnes total | | 26 |
| Staphylococcus | Staphylococcus aureus, mecA | ATCC 33591 | 3 |
| | | ATCC BAA-44 | 5 |
| | | NCTC 12493 | 2 |
| | Staphylococcus aureus, mecC | ATCC BAA-2312 | 23 |
| | | ATCC BAA-2313 | 26 |
| | Staphylococcus epidermidis, mecA | ATCC 35984 | 1 |
| | | ATCC 49576 | 9 |
| | Staphylococcus lugdunensis | NRS 878 | 9 |
| | | NRS 879 | 9 |
| | | NRS 880 | 9 |
| | | NRS 881 | 9 |
| | Staphylococcus total | | 105 |
| Streptococcus | Streptococcus agalactiae | ATCC 12403 | 2 |
| | | ATCC 12973 | 2 |
| | | ATCC 13813 | 2 |
| | | ATCC 27956 | 2 |
| | Streptococcus anginosus | ATCC 700231 | 5 |
| | | ATCC 9895 | 3 |
| | | NCTC 10713 | 5 |
| | Streptococcus constellatus | ATCC 27513 | 4 |
| | | ATCC 27823 | 2 |
| | Streptococcus intermedius | ATCC 27335 | 4 |
| | Streptococcus pyogenes | ATCC 12344 | 5 |
| | | ATCC 12384 | 4 |
| | | ATCC 14289 | 4 |
| | | ATCC 19615 | 4 |
| | | ATCC 49399 | 5 |
| | | NCIMB 13285 | 4 |

28

29

*Derived from clinical specimen

30

Genus and Group Assay Species Stratification

The ePlex BCID-GP Panel reports genus or group level results for Bacillus cereus group, Bacillus subtilis group, Corynebacterium, Enterococcus, Lactobacillus, Listeria, Micrococcus, Staphylococcus, Streptococcus, Streptococcus anginosus group, Pan Gram-Negative and Pan Candida targets. Sensitivity/PPA of these genus and group level targets for species as determined by comparator methods for all evaluable samples tested are summarized in Table 32.

| Target | Sensitivity/PPA
(Prospective) | | Sensitivity/PPA
(Retrospective) | | Sensitivity/PPA
(Contrived) | | Sensitivity/PPA
(Combined) | |
|----------------------------------------------------|----------------------------------|------------------|------------------------------------|------------------|--------------------------------|------------------|-------------------------------|------------------|
| Species detected by
Comparator Method | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) |
| Bacillus cereus group | 5/5 | 100 (56.6-100) | 6/7 | 85.7 (48.7-97.4) | 46/46 | 100 (92.3-100) | 57/58 | 98.3 (90.9-99.7) |
| Bacillus cereus | 3/3 | 100 (43.9-100) | 6/7 | 85.7 (48.7-97.4) | 40/40 | 100 (91.2-100) | 49/50 | 98.0 (89.5-99.6) |
| Bacillus thuringiensis | 2/2 | 100 (34.2-100) | - | - | 6/6 | 100 (61.0-100) | 8/8 | 100 (67.6-100) |
| Bacillus subtilis group | 2/2 | 100 (34.2-100) | - | - | 50/50 | 100 (92.9-100) | 52/52 | 100 (93.1-100) |
| Bacillus amyloliquefaciens | 1/1 | 100 (20.7-100) | - | - | 10/10 | 100 (72.2-100) | 11/11 | 100 (74.1-100) |
| Bacillus atrophaeus | - | - | - | - | 11/11 | 100 (74.1-100) | 11/11 | 100 (74.1-100) |
| Bacillus licheniformis | - | - | - | - | 10/10 | 100 (72.2-100) | 10/10 | 100 (72.2-100) |
| Bacillus subtilis | 1/1 | 100 (20.7-100) | - | - | 19/19 | 100 (83.2-100) | 20/20 | 100 (83.9-100) |
| Corynebacterium | 13/19 | 68.4 (46.0-84.6) | 27/32 | 84.4 (68.2-93.1) | 20/20 | 100 (83.9-100) | 60/71 | 84.5 (74.3-91.1) |
| Corynebacterium | 4/9 | 44.4 (18.9-73.3) | 5/7 | 71.4 (35.9-91.8) | - | - | 9/16 | 56.3 (33.2-76.9) |
| Corynebacterium afermentans | 0/1 | 0.0 (0.0-79.3) | 3/3 | 100 (43.9-100) | - | - | 3/4 | 75.0 (30.1-95.4) |
| Corynebacterium amycolatum | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Corynebacterium
aurimucosum | 1/1 | 100 (20.7-100) | 1/1 | 100 (20.7-100) | - | - | 2/2 | 100 (34.2-100) |
| Corynebacterium casei | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Corynebacterium coyleae | 1/1 | 100 (20.7-100) | 2/2 | 100 (34.2-100) | 7/7 | 100 (64.6-100) | 10/10 | 100 (72.2-100) |
| Corynebacterium falsenii | - | - | - | - | 9/9 | 100 (70.1-100) | 9/9 | 100 (70.1-100) |
| Corynebacterium imitans | 2/2 | 100 (34.2-100) | 2/2 | 100 (34.2-100) | - | - | 4/4 | 100 (51.0-100) |
| Corynebacterium jeikeium | - | - | 4/5 | 80.0 (37.6-96.4) | - | - | 4/5 | 80.0 (37.6-96.4) |
| Corynebacterium
kroppenstedtii | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Corynebacterium matruchotii | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Corynebacterium mucifaciens | 1/1 | 100 (20.7-100) | 2/2 | 100 (34.2-100) | - | - | 3/3 | 100 (43.9-100) |
| Corynebacterium
pseudotuberculosis | - | - | 0/1 | 0.0 (0.0-79.3) | - | - | 0/1 | 0.0 (0.0-79.3) |
| Corynebacterium striatum | 1/1 | 100 (20.7-100) | 6/6 | 100 (61.0-100) | 4/4 | 100 (51.0-100) | 11/11 | 100 (74.1-100) |
| Corynebacterium
tuberculostearicum | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Corynebacterium urealyticum | - | - | 0/1 | 0.0 (0.0-79.3) | - | - | 0/1 | 0.0 (0.0-79.3) |
| Target
Species detected by
Comparator Method | Sensitivity/PPA
(Prospective) | | Sensitivity/PPA
(Retrospective) | | Sensitivity/PPA
(Contrived) | | Sensitivity/PPA
(Combined) | |
| | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) |
| Enterococcus | 61/61 | 100 (94.1-100) | 139/147 | 94.6 (89.6-97.2) | 126/126 | 100 (97.0-100) | 326/334 | 97.6 (95.3-98.8) |
| Enterococcus avium | 1/1 | 100 (20.7-100) | 2/3 | 66.7 (20.8-93.9) | - | - | 3/4 | 75.0 (30.1-95.4) |
| Enterococcus casseliflavus | - | - | 0/1 | 0.0 (0.0-79.3) | - | - | 0/1 | 0.0 (0.0-79.3) |
| Enterococcus casseliflavus /
gallinarum | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Enterococcus faecalis | 49/49 | 100 (92.7-100) | 85/90 | 94.4 (87.6-97.6) | 52/52 | 100 (93.1-100) | 186/191 | 97.4 (94.0-98.9) |
| Enterococcus faecium | 12/12 | 100 (75.8-100) | 52/53 | 98.1 (90.1-99.7) | 60/60 | 100 (94.0-100) | 124/125 | 99.2 (95.6-99.9) |
| Enterococcus flavescens | - | - | - | - | 3/3 | 100 (43.9-100) | 3/3 | 100 (43.9-100) |
| Enterococcus gallinarum | - | - | 2/2 | 100 (34.2-100) | 4/4 | 100 (51.0-100) | 6/6 | 100 (61.0-100) |
| Enterococcus hirae | - | - | - | - | 1/1 | 100 (20.7-100) | 1/1 | 100 (20.7-100) |
| Enterococcus malodoratus | - | - | - | - | 3/3 | 100 (43.9-100) | 3/3 | 100 (43.9-100) |
| Enterococcus raffinosus | - | - | - | - | 2/2 | 100 (34.2-100) | 2/2 | 100 (34.2-100) |
| Enterococcus saccharolyticus | - | - | - | - | 1/1 | 100 (20.7-100) | 1/1 | 100 (20.7-100) |
| Lactobacillus | 4/4 | 100 (51.0-100) | 9/9 | 100 (70.1-100) | 32/33 | 97.0 (84.7-99.5) | 45/46 | 97.8 (88.7-99.6) |
| Lactobacillus casei | - | - | 1/1 | 100 (20.7-100) | 12/12 | 100 (75.8-100) | 13/13 | 100 (77.2-100) |
| Lactobacillus paracasei | 1/1 | 100 (20.7-100) | - | - | 11/11 | 100 (74.1-100) | 12/12 | 100 (75.8-100) |
| Lactobacillus rhamnosus | 2/2 | 100 (34.2-100) | 8/8 | 100 (67.6-100) | 9/10 | 90.0 (59.6-98.2) | 19/20 | 95.0 (76.4-99.1) |
| Lactobacillus zeae | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Listeria | - | - | 2/2 | 100 (34.2-100) | 74/75 | 98.7 (92.8-99.8) | 76/77 | 98.7 (93.0-99.8) |
| Listeria innocua | - | - | - | - | 9/9 | 100 (70.1-100) | 9/9 | 100 (70.1-100) |
| Listeria ivanovii | - | - | - | - | 9/10 | 90.0 (59.6-98.2) | 9/10 | 90.0 (59.6-98.2) |
| Listeria monocytogenes | - | - | 2/2 | 100 (34.2-100) | 46/46 | 100 (92.3-100) | 48/48 | 100 (92.6-100) |
| Listeria seeligeri | - | - | - | - | 5/5 | 100 (56.6-100) | 5/5 | 100 (56.6-100) |
| Listeria welshimeri | - | - | - | - | 5/5 | 100 (56.6-100) | 5/5 | 100 (56.6-100) |
| Micrococcus | 19/21 | 90.5 (71.1-97.3) | 20/23 | 87.0 (67.9-95.5) | 27/27 | 100 (87.5-100) | 66/71 | 93.0 (84.6-97.0) |
| Micrococcus | 8/9 | 88.9 (56.5-98.0) | 10/13 | 76.9 (49.7-91.8) | - | - | 18/22 | 81.8 (61.5-92.7) |
| Micrococcus luteus | 9/9 | 100 (70.1-100) | 8/8 | 100 (67.6-100) | 19/19 | 100 (83.2-100) | 36/36 | 100 (90.4-100) |
| Micrococcus luteus/lylae | 2/3 | 66.7 (20.8-93.9) | 2/2 | 100 (34.2-100) | - | - | 4/5 | 80.0 (37.6-96.4) |
| Micrococcus lylae | - | - | - | - | 4/4 | 100 (51.0-100) | 4/4 | 100 (51.0-100) |
| Micrococcus yunnanensis | - | - | - | - | 4/4 | 100 (51.0-100) | 4/4 | 100 (51.0-100) |
| Target | Sensitivity/PPA
(Prospective) | | Sensitivity/PPA
(Retrospective) | | Sensitivity/PPA
(Contrived) | | Sensitivity/PPA
(Combined) | |
| Species detected by
Comparator Method | TP/
TP+FN | % (95% CI) | ТР/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | ТР/
TP+FN | % (95% CI) |
| Staphylococcus | 447/456 | 98.0 (96.3-99.0) | 185/191 | 96.9 (93.3-98.6) | 105/105 | 100 (96.5-100) | 7371752 | 98.0 (96.7-98.8) |
| Coagulase-negative
staphylococci (CoNS) | 18/18 | 100 (82.4-100) | | | | | 18/18 | 100 (82.4-100) |
| CoNS (Not S. epidermidis, S.
lugdunensis) | 2/2 | 100 (34.2-100) | - | | - | | 2/2 | 100 (34.2-100) |
| Staphylococcus | 74/78 | 94.9 (87.5-98.0) | 1/3 | 33.3 (6.1-79.2) | - | | 75/81 | 92.6 (84.8-96.6) |
| Staphylococcus aureus | 158/160 | 98.8 (95.6-99.7) | 121/123 | 98.4 (94.3-99.6) | રતેન્દિતે | 100 (93.9-100) | 338/342 | 98.8 (97.0-99.5) |
| Staphylococcus aureus subsp.
aureus | 6/6 | 100 (61.0-100) | 2/2 | 100 (34.2-100) | - | | 8/8 | 100 (67.6-100) |
| Staphylococcus auricularis | 2/2 | 100 (34.2-100) | 2/2 | 100 (34.2-100) | - | | 4/4 | 100 (51.0-100) |
| Staphylococcus capitis | 14/14 | 100 (78.5-100) | 7/7 | 100 (64.6-100) | - | | 21/21 | 100 (84.5-100) |
| Staphylococcus carnosus
subsp. carnosus | | | 0/1 | 0.0 (0.0-79.3) | - | | 0/1 | 0.0 (0.0-79.3) |
| Staphylococcus cohnii | 1/2 | 50.0 (9.5-90.5) | | | - | | 1/2 | 50.0 (9.5-90.5) |
| Staphylococcus epidermidis | 117/121 | 96.7 (91.8-98.7) | 37/38 | 97.4 (86.5-99.5) | 1/1 | 100 (20.7-100) | 155/160 | 96.9 (92.9-98.7) |
| Staphylococcus haemolyticus | 6/6 | 100 (61.0-100) | 2/2 | 100 (34.2-100) | - | | 8/8 | 100 (67.6-100) |
| Staphylococcus hominis | 24/24 | 100 (86.2-100) | 13/13 | 100 (77.2-100) | - | | 37/37 | 100 (90.6-100) |
| Staphylococcus hominis subsp.
hominis | 22/22 | 100 (85.1-100) | ર્ટાર | 100 (56.6-100) | - | | 27/27 | 100 (87.5-100) |
| Staphylococcus hominis subsp.
novobiosepticus | 1/1 | 100 (20.7-100) | | | - | | 1/1 | 100 (20.7-100) |
| Staphylococcus lugdunensis | 2/2 | 100 (34.2-100) | 4/4 | 100 (51.0-100) | 45/45 | 100 (92.1-100) | રી/રી | 100 (93.0-100) |
| Staphylococcus pettenkoferi | 2/2 | 100 (34.2-100) | - | | - | | 2/2 | 100 (34.2-100) |
| Staphylococcus
saccharolyticus | 1/1 | 100 (20.7-100) | - | | - | | 1/1 | 100 (20.7-100) |
| Staphylococcus saprophyticus | 1/1 | 100 (20.7-100) | 1/1 | 100 (20.7-100) | - | | 2/2 | 100 (34.2-100) |
| Staphylococcus schleiferi | - | | 1/1 | 100 (20.7-100) | - | | 1/1 | 100 (20.7-100) |
| Staphylococcus simulans | 3/3 | 100 (43.9-100) | - | | | | 3/3 | 100 (43.9-100) |
| Staphylococcus warneri | 4/4 | 100 (51.0-100) | | | | | 4/4 | 100 (51.0-100) |
| Target | Sensitivity/PPA
(Prospective) | | Sensitivity/PPA
(Retrospective) | | Sensitivity/PPA
(Contrived) | | Sensitivity/PPA
(Combined) | |
| Species detected by
Comparator Method | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) |
| Streptococcus | 103/110 | 93.6 (87.4-96.9) | 171/173 | 98.8 (95.9-99.7) | 57/57 | 100 (93.7-100) | 331/340 | 97.4 (95.0-98.6) |
| Alpha Hemolytic
Streptococcus | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Gamma Hemolytic
Streptococcus | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus | 5/7 | 71.4 (35.9-91.8) | - | - | - | - | 5/7 | 71.4 (35.9-91.8) |
| Streptococcus (Group G) | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus agalactiae | 10/11 | 90.9 (62.3-98.4) | 37/37 | 100 (90.6-100) | 8/8 | 100 (67.6-100) | 55/56 | 98.2 (90.6-99.7) |
| Streptococcus anginosus | 1/1 | 100 (20.7-100) | 13/13 | 100 (77.2-100) | 13/13 | 100 (77.2-100) | 27/27 | 100 (87.5-100) |
| Streptococcus anginosus
group | 4/4 | 100 (51.0-100) | 22/22 | 100 (85.1-100) | - | - | 26/26 | 100 (87.1-100) |
| Streptococcus bovis | - | - | 2/2 | 100 (34.2-100) | - | - | 2/2 | 100 (34.2-100) |
| Streptococcus bovis group | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus constellatus | - | - | - | - | 6/6 | 100 (61.0-100) | 6/6 | 100 (61.0-100) |
| Streptococcus constellatus
subsp. constellatus | - | - | 2/2 | 100 (34.2-100) | - | - | 2/2 | 100 (34.2-100) |
| Streptococcus constellatus
subsp. pharyngis | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus dysgalactiae | - | - | 2/2 | 100 (34.2-100) | - | - | 2/2 | 100 (34.2-100) |
| Streptococcus dysgalactiae
(Group G) | 4/4 | 100 (51.0-100) | 1/1 | 100 (20.7-100) | - | - | 5/5 | 100 (56.6-100) |
| Streptococcus gallolyticus | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus gordonii | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus infantarius | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus intermedius | - | - | 2/2 | 100 (34.2-100) | 4/4 | 100 (51.0-100) | 6/6 | 100 (61.0-100) |
| Streptococcus mitis | 9/10 | 90.0 (59.6-98.2) | 14/15 | 93.3 (70.2-98.8) | - | - | 23/25 | 92.0 (75.0-97.8) |
| Streptococcus mitis group | 10/10 | 100 (72.2-100) | - | - | - | - | 10/10 | 100 (72.2-100) |
| Streptococcus mutans | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus oralis | - | - | 3/3 | 100 (43.9-100) | - | - | 3/3 | 100 (43.9-100) |
| Streptococcus parasanguinis | 2/2 | 100 (34.2-100) | 4/4 | 100 (51.0-100) | - | - | 6/6 | 100 (61.0-100) |
| Streptococcus pneumoniae | 28/28 | 100 (87.9-100) | 41/41 | 100 (91.4-100) | - | - | 69/69 | 100 (94.7-100) |
| Streptococcus pyogenes | 8/8 | 100 (67.6-100) | 19/20 | 95.0 (76.4-99.1) | 26/26 | 100 (87.1-100) | 53/54 | 98.1 (90.2-99.7) |
| Streptococcus salivarius | 4/4 | 100 (51.0-100) | 5/5 | 100 (56.6-100) | - | - | 9/9 | 100 (70.1-100) |
| Streptococcus vestibularis | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus viridans group | 14/17 | 82.4 (59.0-93.8) | 2/2 | 100 (34.2-100) | - | - | 16/19 | 84.2 (62.4-94.5) |
| Streptococcus anginosus group | 4/5 | 80.0 (37.6-96.4) | 38/40 | 95.0 (83.5-98.6) | 23/23 | 100 (85.7-100) | 65/68 | 95.6 (87.8-98.5) |
| Streptococcus anginosus | 0/1 | 0.0 (0.0-79.3) | 12/13 | 92.3 (66.7-98.6) | 13/13 | 100 (77.2-100) | 25/27 | 92.6 (76.6-97.9) |
| Streptococcus anginosus group | 4/4 | 100 (51.0-100) | 21/22 | 95.5 (78.2-99.2) | - | - | 25/26 | 96.2 (81.1-99.3) |
| Streptococcus constellatus | - | - | - | - | 6/6 | 100 (61.0-100) | 6/6 | 100 (61.0-100) |
| Streptococcus constellatus spp
constellatus | - | - | 2/2 | 100 (34.2-100) | - | - | 2/2 | 100 (34.2-100) |
| Streptococcus constellatus spp
pharynges | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Streptococcus intermedius | - | - | 2/2 | 100 (34.2-100) | 4/4 | 100 (51.0-100) | 6/6 | 100 (61.0-100) |
| Target
Species detected by
Comparator Method | Sensitivity/PPA
(Prospective) | | Sensitivity/PPA
(Retrospective) | | Sensitivity/PPA
(Contrived) | | Sensitivity/PPA
(Combined) | |
| | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) | TP/
TP+FN | % (95% CI) |
| Pan Candida | - | - | 7/9 | 77.8 (45.3-93.7) | - | - | 7/9 | 77.8 (45.3-93.7) |
| Candida albicans | - | - | 4/4 | 100 (51.0-100) | - | - | 4/4 | 100 (51.0-100) |
| Candida glabrata | - | - | 1/2 | 50 (9.5-90.5) | - | - | 1/2 | 50 (9.5-90.5) |
| Candida krusei | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Candida parapsilosis | - | - | 1/2 | 50 (9.5-90.5) | - | - | 1/2 | 50 (9.5-90.5) |
| Pan Gram-Negative | 22/23 | 95.7 (79.0-99.2) | 36/43 | 83.7 (70.0-91.9) | - | - | 58/66 | 87.9 (77.9-93.7) |
| Acinetobacter baumannii | 3/3 | 100 (43.9-100) | 2/4 | 50.0 (15.0-85.0) | - | - | 5/7 | 71.4 (35.9-91.8) |
| Acinetobacter lwoffii | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Aeromonas caviae | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Bacteroides fragilis | 2/2 | 100 (34.2-100) | - | - | - | - | 2/2 | 100 (34.2-100) |
| Campylobacter gracilis | 0/1 | 0.0 (0.0-79.3) | - | - | - | - | 0/1 | 0.0 (0.0-79.3) |
| Citrobacter braakii | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Citrobacter freundii | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Citrobacter koseri | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |
| Enterobacter aerogenes | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Enterobacter cloacae | - | - | 4/4 | 100 (51.0-100) | - | - | 4/4 | 100 (51.0-100) |
| Escherichia coli | 4/4 | 100 (51.0-100) | 14/14 | 100 (78.5-100) | - | - | 18/18 | 100 (82.4-100) |
| Klebsiella oxytoca | 1/1 | 100 (20.7-100) | 3/3 | 100 (43.9-100) | - | - | 4/4 | 100 (51.0-100) |
| Klebsiella pneumoniae | 4/4 | 100 (51.0-100) | 4/5 | 80.0 (37.6-96.4) | - | - | 8/9 | 88.9 (56.5-98.0) |
| Moraxella (Branhamella)
catarrhalis | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Moraxella catarrhalis | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Morganella morganii | - | - | 2/2 | 100 (34.2-100) | - | - | 2/2 | 100 (34.2-100) |
| Pediococcus pentosaceus | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Proteus mirabilis | 5/5 | 100 (56.6-100) | 4/5 | 80.0 (37.6-96.4) | - | - | 9/10 | 90.0 (59.6-98.2) |
| Proteus vulgaris | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Providencia stuartii | 1/1 | 100 (20.7-100) | 0/1 | 0.0 (0.0-79.3) | - | - | 1/2 | 50.0 (9.5-90.5) |
| Pseudomonas | - | - | 1/1 | 100 (20.7-100) | - | - | 1/1 | 100 (20.7-100) |
| Pseudomonas aeruginosa | 1/1 | 100 (20.7-100) | 1/2 | 50.0 (9.5-90.5) | - | - | 2/3 | 66.7 (20.8-93.9) |
| Serratia marcescens | 2/2 | 100 (34.2-100) | - | - | - | - | 2/2 | 100 (34.2-100) |
| Stenotrophomonas maltophilia | 1/1 | 100 (20.7-100) | 1/1 | 100 (20.7-100) | - | - | 2/2 | 100 (34.2-100) |
| Veillonella species | - | - | 0/1 | 0.0 (0.0-79.3) | - | - | 0/1 | 0.0 (0.0-79.3) |
| Non-fermenting gram-
negative bacilli | 1/1 | 100 (20.7-100) | - | - | - | - | 1/1 | 100 (20.7-100) |

Table 32: Species Detected in Genus and Group Assays by Comparator Methods

31

32

33

34

35

Resistance Gene Assay Species Stratification

Test results for resistance genes are only reported when an associated organism assay is positive in the same sample. See Table 33 for organisms specifically associated with the four resistance markers on the ePlex BCID-GP Panel.

Table 33: Resistance Marker Organism Associations

| Resistance Gene

Result	Associated Targets
mecA and/or mecC	Any Staphylococcus assay ( Staphylococcus , S. aureus , S. epidermidis , S. lugdunensis )
vanA and/or vanB	Any Enterococcus assay ( Enterococcus , E. faecalis , E. faecium )

mecA/mecC

The PPA and NPA of the BCID-GP Panel mecA target stratified by the Staphylococcus species identified by comparator methods for prospective, retrospective and contrived samples are shown in Table 34.

Table 34: Clinical Performance of mecA Target by Staphylococcus Species Detected by

Comparator Methods

Species detected by Comparator Method		Sensitivity/PPA		Specificity/NPA
Coagulase-negative
Staphylococci (CoNS)	Prospective	12/12	100 (75.8-100)	6/6	100 (61.0-100)
	Retrospective	-	-	-	-
	Contrived	-	-	-	-
	Combined	12/12	100 (75.8-100)	6/6	100 (61.0-100)
CoNS (not S. epidermidis /
S. lugdunensis)	Prospective	1/1	100 (20.7-100)	0/1	0.0 (0.0-79.3)
	Retrospective	-	-	-	-
	Contrived	-	-	-	-
	Combined	1/1	100 (20.7-100)	0/1	0.0 (0.0-79.3)
Staphylococcus	Prospective	49/52	94.2 (84.4-98.0)	24/26	92.3 (75.9-97.9)
	Retrospective	1/2	50.0 (9.5-90.5)	1/1	100 (20.7-100)
	Contrived	-	-	-	-
	Combined	50/54	92.6 (82.4-97.1)	25/27	92.6 (76.6-97.9)
Staphylococcus aureus	Prospective	80/83	96.4 (89.9-98.8)	74/77	96.1 (89.2-98.7)
	Retrospective	105/106	99.1 (94.8-99.8)	16/17	94.1 (73.0-99.0)
	Contrived	10/10	100 (72.2-100)	49/49	100 (92.7-100)
	Combined	195/199	98.0 (94.9-99.2)	139/143	97.2 (93.0-98.9)
			Sensitivity/PPA			Specificity/NPA
Species detected by Comparator Method		TP/TP+FN	% (95% CI)		TN/TN+FP	% (95% CI)
Staphylococcus aureus subsp. aureus	Prospective	3/3	100 (43.9-100)		3/3	100 (43.9-100)
	Retrospective	2/2	100 (34.2-100)		0/0	-
	Contrived	-	-		-	-
	Combined	5/5	100 (56.6-100)		3/3	100 (43.9-100)
Staphylococcus auricularis	Prospective	1/1	100 (20.7-100)		1/1	100 (20.7-100)
	Retrospective	0/0	-		2/2	100 (34.2-100)
	Contrived	-	-		-	-
	Combined	1/1	100 (20.7-100)		3/3	100 (43.9-100)
Staphylococcus capitis	Prospective	4/5	80.0 (37.6-96.4)		5/5	100 (56.6-100)
	Retrospective	4/4	100 (51.0-100)		7/7	100 (64.6-100)
	Contrived	-	-		-	-
	Combined	8/9	88.9 (56.5-98.0)		12/12	100 (75.8-100)
Staphylococcus carnosus subsp. carnosus	Prospective	-	-		-	-
	Retrospective	0/0	-		1/1	100 (20.7-100)
	Contrived	-	-		-	-
	Combined	0/0	-		1/1	100 (20.7-100)
Staphylococcus cohnii	Prospective	0/1	0.0 (0.0-79.3)		1/1	100 (20.7-100)
	Retrospective	-	-		-	-
	Contrived	-	-		-	-
	Combined	0/1	0.0 (0.0-79.3)		1/1	100 (20.7-100)
Staphylococcus epidermidis	Prospective	77/79	97.5 (91.2-99.3)		39/42	92.9 (81.0-97.5)
	Retrospective	30/30	100 (88.6-100)		7/8	87.5 (52.9-97.8)
	Contrived	1/1	100 (20.7-100)		0/0	-
	Combined	108/110	98.2 (93.6-99.5)		46/50	92.0 (81.2-96.8)
Staphylococcus haemolyticus	Prospective	4/4	100 (51.0-100)		2/2	100 (34.2-100)
	Retrospective	2/2	100 (34.2-100)		0/0	-
	Contrived	-	-		-	-
	Combined	6/6	100 (61.0-100)		2/2	100 (34.2-100)
Staphylococcus hominis	Prospective	12/13	92.3 (66.7-98.6)		10/11	90.9 (62.3-98.4)
	Retrospective	12/12	100 (75.8-100)		1/1	100 (20.7-100)
	Contrived	-	-		-	-
	Combined	24/25	96.0 (80.5-99.3)		11/12	91.7 (64.6-98.5)
Staphylococcus hominis subsp. hominis	Prospective	10/11	90.9 (62.3-98.4)		11/11	100 (74.1-100)
	Retrospective	2/2	100 (34.2-100)		3/3	100 (43.9-100)
	Contrived	-	-		-	-
	Combined	12/13	92.3 (66.7-98.6)		14/14	100 (78.5-100)
Staphylococcus hominis subsp. novobiosepticus	Prospective	1/1	100 (20.7-100)		0/0	-
	Retrospective	-	-		-	-
	Contrived	-	-		-	-
	Combined	1/1	100 (20.7-100)		0/0	-
Species detected by Comparator Method		Sensitivity/PPA		Specificity/NPA
		TP/TP+FN	% (95% CI)	TN/TN+FP	% (95% CI)
Staphylococcus lugdunensis	Prospective	0/0	---	2/2	100 (34.2-100)
	Retrospective	1/1	100 (20.7-100)	3/3	100 (43.9-100)
	Contrived	0/0	---	45/45	100 (92.1-100)
	Combined	1/1	100 (20.7-100)	50/50	100 (92.9-100)
Staphylococcus pettenkoferi	Prospective	0/0	---	1/2	50.0 (9.5-90.5)
	Retrospective	-	-	-	-
	Contrived	-	-	-	-
	Combined	0/0	---	1/2	50.0 (9.5-90.5)
Staphylococcus saccharolyticus	Prospective	0/0	---	1/1	100 (20.7-100)
	Retrospective	-	-	-	-
	Contrived	-	-	-	-
	Combined	0/0	---	1/1	100 (20.7-100)
Staphylococcus saprophyticus	Prospective	1/1	100 (20.7-100)	0/0	---
	Retrospective	0/0	---	1/1	100 (20.7-100)
	Contrived	-	-	-	-
	Combined	1/1	100 (20.7-100)	1/1	100 (20.7-100)
Staphylococcus schleiferi	Prospective	-	-	-	-
	Retrospective	0/0	---	1/1	100 (20.7-100)
	Contrived	-	-	-	-
	Combined	0/0	---	1/1	100 (20.7-100)
Staphylococcus simulans	Prospective	1/1	100 (20.7-100)	2/2	100 (34.2-100)
	Retrospective	-	-	-	-
	Contrived	-	-	-	-
	Combined	1/1	100 (20.7-100)	2/2	100 (34.2-100)
Staphylococcus warneri	Prospective	0/0	---	4/4	100 (51.0-100)
	Retrospective	-	-	-	-
	Contrived	-	-	-	-
	Combined	0/0	---	4/4	100 (51.0-100)

36

37

38

A comparison of specific Staphylococcus species and mecA identified by comparator methods versus the ePlex BCID-GP Panel results are shown in Table 36 for prospective and retrospective samples.

Table 35: Distribution of mecA Results in Staphylococcus aureus Prospective/Retrospective Samples

	Comparator Method
BCID-GP	Org+/ARG+	Org+/ARG-	Org-	Total
Org+/ARG+	190	2	2	194
Org+/ARG-	വ	88	ব	94
Org-	2	7	1000	1009
Total	1006
1297
194
97
% Agreement (95% CI) for Org+/ARG+: 190/194=97.9 (94.8-99.2)
% Agreement (95% CI) for Org+/ARG-: 88/97=90.7 (83.3-95.0)

| % Agreement (95% CI) for Org-: 1000/1006=99.4 (98.7-99.7)

Table 36: Distribution of mecA Results in Staphylococcus Species (Excluding Known S. aureus, S. epidermidis, S. lugdunensis) Prospective/Retrospective Samples

	Comparator Method
BCID-GP	Org+/ARG+	Org+/ARG-	Org-	Total
Org+/ARG+	33	1	4	38
Org+/ARG-	3	45	8	56
Org-	10*	4	1091	1105
Total	46	50	1103	1199
% Agreement (95% CI) for Org+/ARG+: 33/46=71.7 (57.5-82.7)
% Agreement (95% CI) for Org+/ARG-: 45/50=90.0 (78.6-95.7)
% Agreement (95% CI) for Org-: 1091/1103=98.9 (98.1-99.4)

10 samples had a Staphylococcus species (not S. epidermidis, or S. lugdunensis) with mecA identified by comparator methods, whereas ePlex BCID-GP Panel detected S. epidermidis with mecA.

A table for mecC is not provided because mecC was only detected in a single species,

Staphylococcus aureus. In the 49 contrived samples with Staphylococcus aureus containing

mecC, the resulting PPA and NPA were both 100%.

39

vanA/vanB

The PPA and NPA of the BCID-GP Panel vanA target stratified by the Enterococcus species identified by comparator methods for 208 clinical prospective samples and 126 contrived samples are shown in Table 37.

A table for vanB is not provided because vanB was only detected in 53 samples comprised of two species, E. faecalis (n=43) and E. faecium (n=10), resulting in PPA and NPA of 100%.

Species detected by Comparator Method		Sensitivity/PPA		Specificity/NPA
		TP/TP+FN	% (95% CI)	TN/TN+FP	% (95% CI)
Enterococcus	Prospective	0/0	---	1/1	100 (20.7-100)
	Retrospective	---	---	---	---
	Contrived	---	---	---	---
	Combined	0/0	---	1/1	100 (20.7-100)
Enterococcus avium	Prospective	0/0	---	1/1	100 (20.7-100)
	Retrospective	0/1	0.0 (0.0-79.3)	2/2	100 (34.2-100)
	Contrived	---	---	---	---
	Combined	0/1	0.0 (0.0-79.3)	3/3	100 (43.9-100)
Enterococcus casseliflavus	Prospective	---	---	---	---
	Retrospective	0/0	---	1/1	100 (20.7-100)
	Contrived	---	---	---	---
	Combined	0/0	---	1/1	100 (20.7-100)
Enterococcus casseliflavus /
E. gallinarum	Prospective	---	---	---	---
	Retrospective	0/0	---	1/1	100 (20.7-100)
	Contrived	---	---	---	---
	Combined	0/0	---	1/1	100 (20.7-100)
Enterococcus faecalis	Prospective	1/1	100 (20.7-100)	48/48	100 (92.6-100)
	Retrospective	11/14	78.6 (52.4-92.4)	76/76	100 (95.2-100)
	Contrived	10/10	100 (72.2-100)	42/42	100 (91.6-100)
	Combined	22/25	88.0 (70.0-95.8)	166/166	100 (97.7-100)
Enterococcus faecium	Prospective	7/7	100 (64.6-100)	4/5	80.0 (37.6-96.4)
	Retrospective	44/44	100 (92.0-100)	8/9	88.9 (56.5-98.0)
	Contrived	50/50	100 (92.9-100)	10/10	100 (72.2-100)
	Combined	101/101	100 (96.3-100)	22/24	91.7 (74.2-97.7)
Enterococcus flavescens	Prospective	---	---	---	---
	Retrospective	---	---	---	---
	Contrived	0/0	---	3/3	100 (43.9-100)
	Combined	0/0	---	3/3	100 (43.9-100)

Table 37: Clinical Performance of vanA Target by Enterococcus Species Detected by Comparator Methods

40

Species detected by Comparator Method		Sensitivity/PPA		Specificity/NPA
		TP/TP+FN	% (95% CI)	TN/TN+FP	% (95% CI)
Enterococcus gallinarum	Prospective	-	-	-	-
	Retrospective	0/0	-	2/2	100 (34.2-100)
	Contrived	0/0	---	4/4	100 (51.0-100)
	Combined	0/0	-	6/6	100 (61.0-100)
Enterococcus hirae	Prospective	-	-	-	-
	Retrospective	-	-	-	-
	Contrived	0/0	---	1/1	100 (20.7-100)
	Combined	0/0	-	1/1	100 (20.7-100)
Enterococcus malodoratus	Prospective	-	-	-	-
	Retrospective	-	-	-	-
	Contrived	0/0	---	3/3	100 (43.9-100)
	Combined	0/0	-	3/3	100 (43.9-100)
Enterococcus raffinosus	Prospective	-	-	-	-
	Retrospective	-	-	-	-
	Contrived	0/0	---	2/2	100 (34.2-100)
	Combined	0/0	-	2/2	100 (34.2-100)
Enterococcus saccharolyticus	Prospective	-	-	-	-
	Retrospective	-	-	-	-
	Contrived	0/0	---	1/1	100 (20.7-100)
	Combined	0/0	-	1/1	100 (20.7-100)

41

A comparison of Enterococcus faecalis/Enterococcus faecium and vanA identified by comparator methods versus the ePlex BCID-GP Panel results is shown in Table 38 and Table 39 for prospective and retrospective samples.

Table 38: Distribution of vanA Results in Enterococcus faecalis Prospective/Retrospective Samples

	Comparator Method
BCID-GP	Org+/ARG+	Org+/ARG-	Org-	Total
Org+/ARG+	10	0	0	10
Org+/ARG-		120	1	122
Org-	4*	4	1157	1165
Total	15	124	1158	1297
0/ 1 - 1 - 1 - 1 / 0 - 1 / 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

% Agreement (95% CI) for Org+/ARG+: 10/15=66.7 (41.7-84.8)

% Agreement (95% CI) for Org+/ARG-: 120/124=96.8 (92.0-98.7)

% Agreement (95% CI) for Org-: 1157/1158=99.9 (99.5-100)

*2 of the 4 samples had E. faecium with vanA detected by the ePlex BCID-GP Panel.

Table 39: Distribution of vanA Results in Enterococcus faecium Prospective/Retrospective Samples

	Comparator Method
BCID-GP	Org+/ARG+	Org+/ARG-	Org-	Total
Org+/ARG+	51	2	3	56
Org+/ARG-	0	10	5	15
Org-	0	2	1224	1226
Total	51	14	1232	1297
% Agreement (95% CI) for Org+/ARG+: 51/51=100.0 (93.0-100)
% Agreement (95% CI) for Org+/ARG-: 10/14=71.4 (45.4-88.3)
% Agreement (95% CI) for Org-: 1224/1232=99.4 (98.7-99.7)

42

Co-detections in Clinical Samples

The ePlex BCID-GP Panel identified a total of 103 bacterial co-detections in 1297 clinical samples (prospective/retrospective). In the 711 prospective samples of the clinical study, 38/711 (5.3%) had double detections and 1/711 (0.1%) had a triple detection. In the 586 retrospective samples, 56/586 (9.6%) had co-detections and 8/586 (1.4%) had triple detections. Neither the prospective nor the retrospective arms of the clinical studies contained a sample with more than 3 organisms detected.

In prospective samples, the most common co-detection combination identified by the ePlex BCID-GP Panel was Enterococcus faecalis with Pan Gram-Negative which was detected in 6 samples. Pan Gram-Negative was identified in 17 co-detections, Staphylococcus was identified in 26 co-detections, Enterococcus was identified in 13 co-detections, and Streptococcus was identified in 12 co-detections.

In retrospective samples, the most common co-detection combination identified by the ePlex BCID-GP Panel was Enterococcus faecalis with Pan Gram-Negative which was detected in 9 samples, 2 of which also had vanA detected. Pan Gram-Negative was identified in 33 codetections, Staphylococcus was identified in 22 co-detections, Enterococcus was identified in 34 co-detections, and Streptococcus was identified in 24 co-detections. See Tables 40-41 below for summaries of co-detections in prospective and retrospective samples in targets as determined by the ePlex BCID-GP Panel.

Table 40: Co-Detections Identified by the ePlex BCID-GP Panel in Prospective Clinical
Samples by Target

| Distinct Co-Detection Combinations Detected by the ePlex BCID-GP
Panel in Prospective Clinical Samples | | | | Number Samples
(Number
Discrepant) | Discrepant
Organism(s) /
Resistance
Marker(s)* |
|-----------------------------------------------------------------------------------------------------------|-----------------------|----------|----------------------|------------------------------------------|---------------------------------------------------------|
| Target 1 | Target 2 | Target 3 | Resistance
Marker | | |
| C. acnes | Staphylococcus | | | 1 (1) | C. acnes (1) |
| Corynebacterium | S. epidermidis | | mecA | 2 (0) | |
| E. faecalis | E. faecium | | | 2 (1) | E. faecium (1) |
| E. faecalis | Pan GN | | | 6 (0) | |
| E. faecalis | S. epidermidis | | mecA | 1 (0) | |
| E. faecalis | Staphylococcus | | | 1 (0) | |
| E. faecalis | Staphylococcus | | mecA | 1 (0) | |

43

| Distinct Co-Detection Combinations Detected by the ePlex BCID-GP
Panel in Prospective Clinical Samples | | | | Number Samples
(Number Discrepant) | Discrepant
Organism(s) /
Resistance
Marker(s)* |
|-----------------------------------------------------------------------------------------------------------|--------------------|----------------|----------------------|---------------------------------------|---------------------------------------------------------|
| Target 1 | Target 2 | Target 3 | Resistance
Marker | | |
| E. faecium | Pan GN | Staphylococcus | mecA, vanA | 1 (0) | |
| E. faecium | S. epidermidis | | mecA, vanA | 1 (0) | |
| Lactobacillus | Streptococcus | | | 1 (1) | Lactobacillus (1) |
| Listeria | Staphylococcus | | | 1 (1) | Listeria (1) |
| Pan GN | S. anginosus group | | | 2 (0) | |
| Pan GN | S. aureus | | | 1 (0) | |
| Pan GN | S. epidermidis | | mecA | 2 (2) | Pan GN (1),
S. epidermidis (1) |
| Pan GN | S. pneumoniae | | | 1 (1) | S. pneumoniae (1) |
| Pan GN | Staphylococcus | | | 2 (0) | |
| Pan GN | Staphylococcus | | mecA | 1 (0) | |
| Pan GN | Streptococcus | | | 1 (0) | |
| S. agalactiae | S. aureus | | | 1 (0) | |
| S. anginosus group | Staphylococcus | | | 2 (2) | S. anginosus gp (1),
Staphylococcus (1) |
| S. aureus | S. epidermidis | | mecA | 2 (2) | S. epidermidis (2) |
| S. epidermidis | S. lugdunensis | | | 1 (1) | S. epidermidis (1),
S. lugdunensis (1) |
| S. epidermidis | S. lugdunensis | | mecA | 1 (1) | S. lugdunensis (1) |
| S. epidermidis | Streptococcus | | | 2 (1) | S. epidermidis (1) |
| Staphylococcus | Streptococcus | | | 1 (0) | |
| Staphylococcus | Streptococcus | | mecA | 1 (1) | Streptococcus (1) |

A discrepant result is one that was detected by the ePlex BCID-GP Panel but not by the comparator method(s). 7/16 discrepant organisms were detected using PCR/sequencing as shown below:

-In 1/1 false positive E. faecium samples, E. faecium was detected.

-In 1/1 false positive Lactobacillus samples, Lactobacillus was detected.

-In 2/5 false positive S. epidermidis samples, S. epidermidis was detected.

-In 2/2 false positive S. lugdunensis samples, S. lugdunensis was detected.

-In 1/1 false positive Streptococcus samples, Streptococcus was detected.

Table 41: Co-Detections Identified by the ePlex BCID-GP Panel in Retrospective Clinical

Samples by Target

| Distinct Co-Detection Combinations Detected by the ePlex BCID-GP
Panel in Retrospective Clinical Samples | | | | Number Samples
(Number
Discrepant) | Discrepant
Organism(s) /
Resistance Marker(s)* |
|-------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------|----------------------|------------------------------------------|------------------------------------------------------|
| Target 1 | Target 2 | Target 3 | Resistance
Marker | | |
| Corynebacterium | S. epidermidis | S. lugdunensis | mecA | 1 (1) | Corynebacterium (1) |
| Corynebacterium | Staphylococcus | | | 1 (0) | |
| Corynebacterium | Staphylococcus | | mecA | 1 (0) | |
| E. faecalis | E. faecium | | | 4 (3) | E. faecium (3) |
| E. faecalis | E. faecium | | vanA | 3 (1) | E. faecium (1) |
| Distinct Co-Detection Combinations Detected by the ePlex BCID-GP
Panel in Retrospective Clinical Samples | | | | Number Samples
(Number
Discrepant) | Discrepant
Organism(s) /
Resistance Marker(s)* |
| Target 1 | Target 2 | Target 3 | Resistance
Marker | | |
| E. faecalis | Pan Candida | | | 1 (0) | |
| E. faecalis | Pan GN | | | 6 (0) | |
| E. faecalis | Pan GN | | vanA | 2 (0) | |
| E. faecalis | Pan GN | S. aureus | | 1 (0) | |
| E. faecalis | S. aureus | | mecA | 1 (0) | |
| E. faecalis | Staphylococcus | | vanA | 1 (1) | Staphylococcus (1) |
| E. faecium | Lactobacillus | Pan GN | vanA | 1 (1) | Lactobacillus (1) |
| E. faecium | Pan Candida | | vanA | 1 (1) | E. faecium (1) |
| E. faecium | Pan Candida | S. epidermidis | mecA, vanA | 1 (1) | S. epidermidis (1) |
| E. faecium | Pan GN | | | 3 (0) | |
| E. faecium | Pan GN | | vanA | 5 (0) | |
| E. faecium | Pan GN | Staphylococcus | mecA, vanA | 1 (0) | |
| E. faecium | S. aureus | | mecA, vanA | 1 (0) | |
| E. faecium | Streptococcus | | vanA | 1 (1) | Streptococcus (1) |
| Enterococcus | S. anginosus group | | | 1 (0) | |
| Lactobacillus | S. anginosus group | | | 1 (0) | |
| Micrococcus | S. pyogenes | | | 1 (1) | Micrococcus (1) |
| Pan Candida | S. epidermidis | | mecA | 2 (0) | |
| Pan Candida | S. pneumoniae | | | 1 (0) | |
| Pan GN | S. agalactiae | | | 2 (1) | Pan GN (1) |
| Pan GN | S. anginosus group | | | 4 (0) | |
| Pan GN | S. anginosus group | S. aureus | | 1 (1) | Pan GN (1) |
| Pan GN | S. aureus | | | 1 (0) | |
| Pan GN | S. aureus | S. epidermidis | mecA | 1 (1) | S. epidermidis (1) |
| Pan GN | S. pneumoniae | | | 2 (0) | |
| Pan GN | Streptococcus | | | 3 (0) | |
| S. agalactiae | S. aureus | | | 2 (0) | |
| S. agalactiae | S. aureus | | mecA | 1 (0) | |
| S. agalactiae | S. aureus | S. epidermidis | mecA | 1 (1) | S. epidermidis (1) |
| S. aureus | S. epidermidis | | mecA | 1 (0) | |
| S. aureus | Streptococcus | | mecA | 2 (1) | Streptococcus (1) |
| S. epidermidis | Streptococcus | | mecA | 1 (0) | |

44

A discrepant result is one that was detected by the ePlex BCID-GP Panel but not by the comparator method(s). 6/16 discrepant organisms were detected using PCR/sequencing as shown below:

-In 1/1 false positive Corynebacterium samples, Corynebacterium was detected.

-In 2/5 false positive E. faecium samples, E. faecium was detected.

-In 1/1 false positive Staphylococcus samples, Staphylococcus was detected.

-In 2/2 false positive Streptococcus samples, Streptococcus was detected.

45

Additional co-detection combinations identified by comparator method(s) are summarized in

Table 42 and Table 43 for prospective and retrospective samples, respectively.

Table 42: Additional Co-Detections Identified by Comparator Method(s) in Prospective
Clinical Samples by Organism

| Distinct Co-Detection Combinations Detected by the
Comparator Methods in Prospective Clinical Samples | | | | | Number
Samples
(Number
Discrepant) | Discrepant
Organism(s)/
Resistance
Markers(s)* |
|----------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------|--------------------------|----------------------|---------------------------------------------|---------------------------------------------------------|
| Organism 1 | Organism 2 | Organism 3 | Organism 4 | Resistance
Marker | | |
| A. baumannii | E. faecium | Staphylococcus | | mecA, vanA | 1 (0) | |
| A. baumannii | S. aureus | | | | 1 (0) | |
| A. baumannii | Staphylococcus | | | mecA | 1 (0) | |
| Acinetobacter lwoffii | Staphylococcus
hominis | | | mecA | 1 (0) | |
| Aerococcus viridansA | K. oxytoca | S. epidermidis | Staphylococcus
cohnii | mecA | 1 (1) | S. cohnii (1),
S. epidermidis (1),
mecA (1) |
| Aerococcus viridansA | Staphylococcus
hominis | | | | 1 (0) | |
| B. fragilis | Clostridium
speciesA | | | | 1 (0) | |
| B. fragilis | S. anginosus gp | | | | 1 (0) | |
| C. acnes | S. epidermidis | | | | 1 (1) | S. epidermidis (1) |
| C. acnes | S. lugdunensis | | | | 1 (1) | C. acnes (1) |
| Citrobacter freundii | K. pneumoniae | Staphylococcus
hominis | | mecA | 1 (1) | mecA (1) |
| Citrobacter koseri | E. faecalis | | | | 1 (0) | |
| Corynebacterium | S. epidermidis | Streptococcus | | mecA | 1 (1) | Streptococcus (1) |
| Corynebacterium | Streptococcus | | | | 1 (1) | Corynebacterium (1) |
| E. coli | E. faecalis | P. mirabilis | | | 1 (0) | |
| E. coli | Lactococcus
lactisA | | | | 1 (0) | |
| E. coli | P. mirabilis | Providencia
stuartii | S. anginosus gp | | 1 (0) | |
| E. faecalis | E. faecium | | | | 1 (1) | E. faecium (1) |
| E. faecalis | K. pneumoniae | | | | 2 (0) | |
| E. faecalis | P. mirabilis | | | | 1 (0) | |
| E. faecalis | S. aureus | | | mecA | 1 (1) | S. aureus (1),
mecA (1) |
| E. faecalis | S. marcescens | | | | 1 (0) | |
| E. faecalis | Staphylococcus
(CoNS) | | | mecA | 1 (0) | |
| E. faecium | S. epidermidis | Staphylococcus
haemolyticus | | mecA, vanA | 1 (0) | |
| K. pneumoniae | Staphylococcus
haemolyticus | non-fermenting
GN bacilli | | | 1 (0) | |
| P. aeruginosa | P. mirabilis | Streptococcus -
viridans group | | | 1 (0) | |
| P. mirabilis | Staphylococcus | | | mecA | 1 (1) | Staphylococcus (1),
mecA (1) |
| Peptostreptococcus
speciesA | Staphylococcus | | | | 1 (0) | |

46

| Distinct Co-Detection Combinations Detected by the
Comparator Methods in Prospective Clinical Samples | | | | | Number
Samples
(Number
Discrepant) | Discrepant
Organism(s)/
Resistance
Markers(s)* |
|----------------------------------------------------------------------------------------------------------|-----------------------------------|-----------------------------|------------|----------------------|---------------------------------------------|---------------------------------------------------------|
| Organism 1 | Organism 2 | Organism 3 | Organism 4 | Resistance
Marker | | |
| Rothia
(stomatococcus)
mucilaginosusA | S. epidermidis | | | | 1 (0) | |
| Rothia mucilaginosaA | Streptococcus -
viridans group | | | | 1 (0) | |
| S. agalactiae | S. aureus | Staphylococcus | | mecA | 1 (1) | S. aureus (1),
Staphylococcus (1),
mecA (1) |
| S. anginosus | Streptococcus
mitis | | | | 1 (1) | S. anginosus (1) |
| S. epidermidis | Staphylococcus
capitis | | | mecA | 1 (0) | |
| S. epidermidis | Staphylococcus
hominis | | | | 2 (0) | |
| S. epidermidis | Staphylococcus
hominis | | | mecA | 4 (1) | S. epidermidis (1) |
| S. epidermidis | Staphylococcus
hominis | Staphylococcus
warneri | | | 1 (0) | |
| S. epidermidis | Streptococcus -
viridans group | | | | 1 (1) | S. epidermidis (1) |
| S. epidermidis | Streptococcus
parasanguinis | | | | 1 (0) | |
| S. maltophilia | Streptococcus | | | | 1 (1) | Streptococcus (1) |
| S. marcescens | Streptococcus
mitis group | Streptococcus
salivarius | | | 1 (0) | |
| Staphylococcus cohnii | Streptococcus -
viridans group | | | | 1 (1) | S. viridans group (1) |
| Staphylococcus
hominis | Staphylococcus
pettenkoferi | | | | 1 (0) | |
| Staphylococcus
hominis | Streptococcus
mitis | | | mecA | 1 (1) | mecA (1) |

A discrepant result is one that was detected by the comparator method(s) but not by the ePlex BCID-GP Panel (excludes organisms not targeted by the ePlex BCID-GP Panel). 16 discrepant organisms were investigated using PCR/sequencing; 1 discrepant organism was not detected:

-In 1/1 false negative S. anginosus group sample, PCR/Sequencing instead detected Streptococcus dysgalactiae.

A. Off-panel organisms not targeted by the ePlex BCID-GP Panel.

Table 43: Additional Co-Detections Identified by Comparator Method(s) in Retrospective

Clinical Samples by Organism

| Distinct Co-Detection Combinations Detected by the
Comparator Methods in Retrospective Clinical Samples | | | | | Number
Samples
(Number
Discrepant) | Discrepant
Organism(s)/
Resistance
Markers(s)* |
|------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------|-----------------------------------|----------------------|---------------------------------------------|---------------------------------------------------------|
| Organism 1 | Organism 2 | Organism 3 | Organism 4 | Resistance
Marker | | |
| A. baumannii | E. faecalis | | | vanA | 2 (2) | A. baumannii (2) |
| A. baumannii | E. faecalis | S. aureus | | mecA | 1 (1) | mecA (1) |
| A. baumannii | E. faecium | | | vanA | 1 (0) | |
| Aerococcus
sanguinicolaA | Corynebacterium | Staphylococcus
saprophyticus | | | 1 (0) | |
| Distinct Co-Detection Combinations Detected by the
Comparator Methods in Retrospective Clinical Samples | | | | | Number
Samples
(Number
Discrepant) | Discrepant
Organism(s)/
Resistance
Markers(s)* |
| Organism 1 | Organism 2 | Organism 3 | Organism 4 | Resistance
Marker | (Number
Discrepant) | Resistance
Markers(s)* |
| Aeromonas caviae | E. coli | Enterococcus
casseliflavus | K. oxytoca | | 1 (1) | E. casseliflavus
(1) |
| C. acnes | Enterococcus
avium | | | vanA | 1 (1) | E. avium (1),
vanA (1) |
| C. albicans | E. faecalis | | | vanA | 1 (1) | E. faecalis (1) |
| C. albicans | E. faecium | Staphylococcus
hominis | | mecA, vanA | 1 (0) | |
| C. albicans | S. epidermidis | | | mecA | 1 (0) | |
| C. glabrata | Lactobacillus
rhamnosus | | | | 1 (1) | C. glabrata (1) |
| C. glabrata | S. pneumoniae | | | | 1 (0) | |
| C. krusei | S. epidermidis | | | mecA | 1 (0) | |
| C. parapsilosis | E. faecalis | | | | 1 (0) | |
| C. parapsilosis | E. faecalis | | | vanA | 1 (1) | C. parapsilosis
(1) |
| Citrobacter braakii | Streptococcus
oralis | | | | 1 (0) | |
| E. cloacae | E. faecalis | | | | 1 (0) | |
| E. cloacae | E. faecium | | | vanA | 1 (0) | |
| E. cloacae | E. faecium | Staphylococcus
hominis | | mecA, vanA | 1 (0) | |
| E. cloacae | S. anginosus gp | | | | 1 (0) | |
| E. coli | E. faecalis | | | | 3 (0) | |
| E. coli | E. faecalis | K. pneumoniae | | | 1 (0) | |
| E. coli | E. faecalis | P. mirabilis | | | 1 (0) | |
| E. coli | E. faecium | | | | 2 (0) | |
| E. coli | K. oxytoca | Streptococcus
infantarius | | | 1 (0) | |
| E. coli | S. agalactiae | | | | 1 (0) | |
| E. coli | S. anginosus gp | | | | 1 (0) | |
| E. coli | S. aureus | | | mecA | 1 (0) | |
| E. coli | S. pneumoniae | | | | 1 (0) | |
| E. coli | Streptococcus
bovis | | | | 1 (0) | |
| E. faecalis | K. pneumoniae | | | vanA | 1 (1) | E. faecalis (1),
K. pneumoniae
(1) |
| E. faecalis | M. morganii | | | vanA | 1 (0) | |
| E. faecalis | M. morganii | Proteus vulgaris | | vanA | 1 (1) | E. faecalis (1),
vanA (1) |
| E. faecalis | P. aeruginosa | S. aureus | | mecA | 1 (1) | E. faecalis (1),
P. aeruginosa (1) |
| E. faecalis | P. mirabilis | | | | 2 (2) | E. faecalis (1),
P. mirabilis (1) |
| E. faecalis | P. mirabilis | | | vanA | 1 (1) | E. faecalis (1),
vanA (1) |
| E. faecalis | Providencia
stuartii | | | | 1 (1) | P. stuartii (1) |
| E. faecalis | S. maltophilia | | | vanA | 1 (0) | |
| Distinct Co-Detection Combinations Detected by the
Comparator Methods in Retrospective Clinical Samples | Number
Samples
(Number
Discrepant) | Discrepant
Organism(s)/
Resistance
Markers(s)* | | | | |
| Organism 1 | Organism 2 | Organism 3 | Organism 4 | Resistance
Marker | | |
| E. faecium | Moraxella
(Branhamella)
catarrhalis | Pediococcus
pentosaceus | | vanA | 1 (0) | |
| E. faecium | P. aeruginosa | | | vanA | 1 (0) | |
| E. faecium | P. mirabilis | | | vanA | 1 (0) | |
| E. faecium | Pseudomonas | | | vanA | 1 (0) | |
| E. faecium | S. epidermidis | Staphylococcus
hominis | | mecA | 1 (1) | E. faecium (1) |
| Enterobacter
aerogenes | S. anginosus gp | | | | 1 (0) | |
| Enterococcus avium | S. anginosus gp | | | | 1 (0) | |
| K. oxytoca | S. anginosus gp | | | | 1 (0) | |
| K. pneumoniae | S. aureus | | | | 2 (1) | S. aureus (1) |
| L. monocytogenes | Staphylococcus | | | mecA | 1 (1) | Staphylococcus
(1), mecA (1) |
| Lactobacillus casei | Veillonella
species | | | | 1 (1) | Veillonella
species (1) |
| Lactobacillus
rhamnosus | Pediococcus
acidilacticiA | | | | 1 (0) | |
| Lactobacillus
rhamnosus | S. anginosus gp | Staphylococcus | Streptococcus -
viridans group | | 1 (1) | Staphylococcus
(1) |
| Micrococcus | Pseudoclavibact
erA | | | | 1 (0) | |
| Moraxella catarrhalis | S. pneumoniae | | | | 1 (0) | |
| S. agalactiae | S. aureus | | | | 1 (1) | S. aureus (1) |
| S. agalactiae | S. aureus | Streptococcus -
viridans group | | | 1 (0) | |
| S. aureus | S. epidermidis | | | | 1 (1) | S. aureus (1) |
| S. aureus | S. pyogenes | | | mecA | 1 (1) | S. pyogenes (1) |
| S. aureus | Staphylococcus
capitis | | | | 1 (0) | |
| S. aureus | Streptococcus
mitis | | | mecA | 1 (0) | |
| S. epidermidis | Staphylococcus
hominis | | | | 1 (0) | |
| S. epidermidis | Staphylococcus
hominis | | | mecA | 3 (0) | |
| S. epidermidis | Staphylococcus
hominis | Streptococcus
parasanguinis | | mecA | 1 (0) | |
| Staphylococcus capitis | Staphylococcus
hominis | | | mecA | 1 (0) | |

47

48

A discrepant result is one that was detected by the comparator method(s) but not by the ePlex BCID-GP Panel (excludes organisms not targeted by the ePlex BCID-GP Panel). 24 discrepant organisms were investigated using PCR/sequencing; 2 discrepant organisms were not detected:

-In 2/6 false negative E. faecalis samples, PCR/Sequencing instead detected Enterococcus faecium.

A. Off-panel organisms not targeted by the ePlex BCID-GP Panel.

49

Clinical Study ePlex Instrument Performance

A total of 2354 samples (including prospective, retrospective, and contrived samples) were initially tested in the clinical evaluations. Of these, 24/2354 (1.0%) did not complete the run and the sample was retested. After repeat testing, all 2354 samples completed testing and 2246/2354 (95.4%, 95% CI: 94.5%-96.2%) generated valid results and 108/2354 (4.6%, 95% CI: 3.8%-5.5%) generated invalid results on the first completed attempt.

Upon repeat testing of the 108 samples with initially invalid results, 3/108 (2.8%) did not complete the run and the sample was retested. After repeat testing, all 108 samples completed testing and 106/108 (98.1%) generated valid results. Overall, after final testing, 2/2354 (0.1%, 95% CI: 0.0%-0.3%) had final, invalid results, resulting in a final validity rate of 2352/2354 (99.9%, 95% CI: 99.7%-100%).

ANALYTICAL PERFORMANCE CHARACTERISTICS

Limit of Detection (Analytical Sensitivity)

The limit of detection (LoD), or analytical sensitivity, was identified and verified for each assay on the BCID-GP Panel using at least two quantified reference strains in simulated blood culture sample matrix, which is defined as a whole blood with EDTA added to a blood culture bottle in the same ratio as the manufacturer recommends and incubated for 8 hours. At least 20 replicates per target were tested for each condition. The limit of detection was defined as the lowest concentration of each target that is detected in ≥95% of tested replicates. The confirmed LoD for each ePlex BCID-GP Panel organism is shown in Table 44.

50

Table 44: LoD Results Summary

| Target | Organism | Strain | LoD Concentration
(CFU/mL) |
|--------------------------------|--------------------------------|---------------|-------------------------------|
| B. cereus group | Bacillus cereus | ATCC 21769 | 1 x 105 |
| B. cereus group | Bacillus thuringiensis | ATCC 35646 | 1 x 105 |
| B. subtilis group | Bacillus subtilis | ATCC 55614 | 1 x 106 |
| B. subtilis group | Bacillus atrophaeus | ATCC 51189 | 1 x 106 |
| Corynebacterium | Corynebacterium striatum | ATCC 43735 | 1 x 106 |
| Corynebacterium | Corynebacterium jeikeium | ATCC 43217 | 1 x 107 |
| Cutibacterium acnes (P. acnes) | Cutibacterium acnes (P. acnes) | ATCC 33179 | 1 x 107 |
| Cutibacterium acnes (P. acnes) | Cutibacterium acnes (P. acnes) | ATCC 6919 | 1 x 108 |
| Enterococcus | Enterococcus faecium | ATCC BAA-2316 | 1 x 105 |
| Enterococcus | Enterococcus faecium | ATCC BAA-2317 | 1 x 106 |
| Enterococcus | Enterococcus raffinosus | ATCC 49464 | 1 x 106 |
| Enterococcus faecium | Enterococcus faecium | ATCC BAA-2316 | 1 x 105 |
| Enterococcus faecium | Enterococcus faecium | ATCC BAA-2317 | 1 x 106 |
| Enterococcus faecalis | Enterococcus faecalis | ATCC 51575 | 1 x 106 |
| Enterococcus faecalis | Enterococcus faecalis | ATCC 700802 | 1 x 106 |
| Lactobacillus | Lactobacillus paracasei | ATCC 25598 | 1 x 105 |
| Lactobacillus | Lactobacillus casei | ATCC 334 | 1 x 105 |
| Listeria | Listeria seeligeri | ATCC 35967 | 1 x 105 |
| Listeria | Listeria monocytogenes | ATCC 10890 | 1 x 105 |
| Listeria monocytogenes | Listeria monocytogenes | ATCC 19111 | 1 x 106 |
| Listeria monocytogenes | Listeria monocytogenes | ATCC 10890 | 1 x 105 |
| Listeria monocytogenes | Listeria monocytogenes | ATCC 19111 | 1 x 105 |
| Micrococcus | Micrococcus luteus | ATCC 19212 | 1 x 106 |
| Micrococcus | Micrococcus luteus | ATCC 10240 | 1 x 107 |
| Staphylococcus | Staphylococcus aureus | ATCC BAA-2313 | 1 x 104 |
| Staphylococcus | Staphylococcus aureus | ATCC BAA-2312 | 1 x 105 |
| Staphylococcus | Staphylococcus epidermidis | ATCC 35983 | 1 x 105 |
| Staphylococcus | Staphylococcus epidermidis | ATCC 35984 | 1 x 105 |
| Staphylococcus | Staphylococcus lugdunensis | NRS 879 | 1 x 105 |
| Staphylococcus | Staphylococcus lugdunensis | ATCC 49576 | 1 x 106 |
| Staphylococcus | Staphylococcus haemolyticus | NRS 62 | 1 x 107 |
| Staphylococcus aureus | Staphylococcus aureus | ATCC BAA-2313 | 1 x 105 |
| Staphylococcus aureus | Staphylococcus aureus | ATCC BAA-2312 | 1 x 105 |
| Staphylococcus epidermidis | Staphylococcus epidermidis | ATCC 35983 | 1 x 105 |
| Staphylococcus epidermidis | Staphylococcus epidermidis | ATCC 35984 | 1 x 105 |
| Staphylococcus lugdunensis | Staphylococcus lugdunensis | NRS 879 | 1 x 105 |
| | Staphylococcus lugdunensis | ATCC 49576 | 1 x 105 |
| Streptococcus | Streptococcus pneumoniae | ATCC BAA-475 | 1 x 105 |
| Streptococcus | Streptococcus pneumoniae | ATCC 10357 | 1 x 105 |
| Streptococcus | Streptococcus gordonii | ATCC 10558 | 1 x 106 |
| Streptococcus | Streptococcus agalactiae | ATCC 12401 | 1 x 106 |
| Streptococcus | Streptococcus agalactiae | ATCC 13813 | 1 x 107 |
| Target | Organism | Strain | LoD Concentration
(CFU/mL) |
| Streptococus agalactiae | Streptococus agalactiae | ATCC 12401 | 1 x 105 |
| Streptococus agalactiae | Streptococus agalactiae | ATCC 13813 | 1 x 106 |
| Streptococcus anginosus group | Streptococus intermedius | ATCC 27335 | 1 x 104 |
| Streptococcus anginosus group | Streptococus anginosus | ATCC 9895 | 1 x 106 |
| Streptococus pneumoniae | Streptococus pneumoniae | ATCC BAA-475 | 1 x 105 |
| Streptococus pneumoniae | Streptococus pneumoniae | ATCC 10357 | 1 x 105 |
| Streptococus pyogenes | Streptococus pyogenes | ATCC 12384 | 1 x 105 |
| Streptococus pyogenes | Streptococus pyogenes | ATCC 49399 | 1 x 105 |
| Pan Gram-Negative | Stenotrophomonas maltophilia | ATCC 13636 | 1 x 106 |
| Pan Gram-Negative | Enterobacter cloacae | ATCC 13047 | 1 x 106 |
| Pan Gram-Negative | Escherichia coli | ATCC 4157 | 1 x 106 |
| Pan Gram-Negative | Klebsiella pneumoniae | ATCC BAA-1706 | 1 x 106 |
| Pan Gram-Negative | Serratia marcescens | ATCC 8100 | 1 x 106 |
| Pan Gram-Negative | Proteus mirabilis | ATCC 43071 | 1 x 106 |
| Pan Gram-Negative | Acinetobacter baumannii | NCTC13302 | 1 x 107 |
| Pan Gram-Negative | Neisseria meningitidis | ATCC 13113 | 1 x 107 |
| Pan Gram-Negative | Pseudomonas aeruginosa | ATCC 15442 | 1 x 107 |
| Pan Candida | Candida albicans | ATCC 24433 | 1 x 106 |
| Pan Candida | Candida glabrata | ATCC 66032 | 1 x 106 |
| mecA | Staphylococcus epidermidis | ATCC 35983 | 1 x 105 |
| mecA | Staphylococcus epidermidis | ATCC 35984 | 1 x 105 |
| mecC | Staphylococcus aureus | ATCC BAA-2313 | 1 x 104 |
| mecC | Staphylococcus aureus | ATCC BAA-2312 | 1 x 104 |
| vanA | Enterococcus faecium | ATCC BAA-2316 | 1 x 104 |
| vanA | Enterococcus faecium | ATCC BAA-2317 | 1 x 105 |
| vanB | Enterococcus faecalis | ATCC 51575 | 1 x 105 |
| vanB | Enterococcus faecalis | ATCC 700802 | 1 x 105 |

51

Analytical Reactivity (Inclusivity)

A panel of 459 strains/isolates representing the genetic, temporal and geographic diversity of each target on the ePlex BCID-GP Panel was evaluated to demonstrate analytical reactivity. Each bacterial strain was tested in triplicate at 1 x 10° CFU/mL or less and each fungal strain was tested at 1 x 106 CFU/mL. In the cases where the initial testing concentration did not result in a "Detected" result, the concentration was increased to the point where detection was observed (see footnotes for concentrations of these strains). Organisms detected are shown in Table 45. Additional strains were detected as a part of the Limit of Detection (Analytical Sensitivity) study and can be found in Table 44.

52

	Table 45: Analytical Reactivity (Inclusivity) Results

Organism	Strain
Bacillus cereus	ATCC 21769
Bacillus cereus	ATCC 10876
Bacillus cereus	ATCC 31430
Bacillus cereus	ATCC 53522
Bacillus cereus	ATCC 35646
Bacillus cereus	ATCC 33679
Bacillus thuringiensis	ATCC 55173
Bacillus thuringiensis	ATCC 10792
Bacillus subtilis
Bacillus amyloliquefaciens	ATCC 23845
Bacillus amyloliquefaciens	ATCC 23842
Bacillus amyloliquefaciens	ATCC 23350
Bacillus amyloliquefaciens	ATCC 53495
Bacillus amyloliquefaciens	ATCC 51189
Bacillus atrophaeus	ATCC 6455
Bacillus atrophaeus	ATCC 49337
Bacillus atrophaeus	ATCC 7972
Bacillus atrophaeus	ATCC 6537
Bacillus licheniformis	ATCC 53926
Bacillus licheniformis	ATCC 55768
Bacillus licheniformis	ATCC 21039
Bacillus licheniformis	ATCC 21667
Bacillus licheniformis	ATCC 55614
Bacillus licheniformis	ATCC 15561
Bacillus subtilis	ATCC 21008
Bacillus subtilis	ATCC 15040
Corynebacterium
Corynebacterium afermentans subsp. afermentans	ATCC 51403A
Corynebacterium afermentans subsp. lipophilum	ATCC 51404
Corynebacterium confusum	ATCC 38268A
Corynebacterium coyleae	ATCC 700219
Corynebacterium diphtheriae	ATCC 13812
Corynebacterium falsenii	ATCC BAA-596A
Corynebacterium freneyi	ATCC 64424B
Corynebacterium imitans	ATCC 700354B
Corynebacterium jeikeium	ATCC 43217
Corynebacterium jeikeium	ATCC 43216
Corynebacterium jeikeium	ATCC 43734
Corynebacterium jeikeium	ATCC BAA-949
Corynebacterium minutissimum	ATCC 23348
Corynebacterium resistens	CCUG 50093T
Corynebacterium simulans	ATCC BAA-15
Corynebacterium simulans	ATCC BAA-1293
Corynebacterium striatum	ATCC 43735
Organism	Strain
Staphylococcus lentus	ATCC 700403
Staphylococcus lugdunensis	NRS-879
Staphylococcus lugdunensis	ATCC 49576
Staphylococcus lugdunensis	NRS-878
Staphylococcus lugdunensis	NRS-880
Staphylococcus muscae	ATCC 49910
Staphylococcus pasteuri	ATCC 51129
Staphylococcus pasteuri (mecC+)	ATCC 51128
Staphylococcus pettenkoferi	DSM-19554
Staphylococcus pseudintermedius	ATCC 49444
Staphylococcus saccharolyticus	ATCC 14953
Staphylococcus saprophyticus	ATCC 15305
Staphylococcus saprophyticus	ATCC 35552
Staphylococcus schleiferi	ATCC 49545
Staphylococcus schleiferi	ATCC 43808
Staphylococcus sciuri	ATCC 29060
Staphylococcus sciuri	ATCC 29061
Staphylococcus sciuri	ATCC 29059
Staphylococcus sciuri	ATCC 49575
Staphylococcus sciuri	ATCC 29062
Staphylococcus simulans	ATCC 27848
Staphylococcus simulans	ATCC 27850
Staphylococcus simulans	ATCC 31432
Staphylococcus simulans	ATCC 27851
Staphylococcus species	ATCC 155
Staphylococcus species (mecA+)	ATCC 27626
Staphylococcus vitulinus	ATCC 51699
Staphylococcus vitulinus	ATCC 51161
Staphylococcus warneri	ATCC 27836
Staphylococcus xylosus	ATCC 49148
Staphylococcus xylosus	ATCC 29971
Staphylococcus aureus	ATCC 25923
Staphylococcus aureus	ATCC 29247
Staphylococcus aureus	ATCC 6538P
Staphylococcus aureus	ATCC 29213
Staphylococcus aureus	NR-45889
Staphylococcus aureus	NR-45890
Staphylococcus aureus	NR-46074
Staphylococcus aureus	NR-45881
Staphylococcus aureus	NR-46411
Staphylococcus aureus	NR-46414
Staphylococcus aureus	NR-46418
Staphylococcus aureus	NR-46417
Staphylococcus aureus	NR-13524

53

Organism	Strain
Corynebacterium timonense	CCUG 64728A
Corynebacterium ulcerans	ATCC 51799
Corynebacterium urealyticum	ATCC 43044
Corynebacterium urealyticum	ATCC 43042
Corynebacterium urealyticum	ATCC 43043
Corynebacterium
ureicelerivorans	CCUG 59144
Cutibacterium acnes	ATCC 11827
Cutibacterium acnes	ATCC 11828
Cutibacterium acnes	ATCC 33179
Cutibacterium acnes	ATCC 6919
Enterococcus
Enterococcus avium	ATCC 14025
Enterococcus casseliflavus	ATCC 700668
Enterococcus casseliflavus	ATCC 25788
Enterococcus casseliflavus	ATCC 700327
Enterococcus cecorum	ATCC 43198
Enterococcus dispar	ATCC 51266
Enterococcus durans	ATCC 11576
Enterococcus durans	ATCC 51575
Enterococcus durans	ATCC 700802
Enterococcus durans	ATCC 10100
Enterococcus durans	ATCC 12399
Enterococcus faecalis	ATCC 14506
Enterococcus faecalis	ATCC 33186
Enterococcus faecalis	ATCC 49532
Enterococcus faecalis	ATCC 49533
Enterococcus faecalis	ATCC 7080
Enterococcus faecalis	ATCC 49474
Enterococcus faecalis	ATCC 49332
Enterococcus faecalis	ATCC 29200
Enterococcus faecalis	ATCC BAA-2128
Enterococcus faecalis	ATCC 51188
Enterococcus faecalis	ATCC 49149
Enterococcus faecalis	NCTC-775
Enterococcus faecalis	ATCC 19433
Enterococcus faecalis	ATCC 49452
Enterococcus faecalis (vanA+)	JMI 876745
Enterococcus faecalis (vanB+)	ATCC BAA-2365
Enterococcus faecalis (vanB+)	ATCC 51299
Enterococcus faecium	ATCC 19434
Enterococcus faecium	ATCC 23828
Enterococcus faecium	ATCC 27273
Enterococcus faecium	ATCC BAA-2127
Enterococcus faecium	ATCC 6057
Enterococcus faecium	ATCC 49624
Enterococcus faecium	ATCC 6569
Enterococcus faecium	ATCC BAA-472
Organism	Strain
	NR-13525
	NR-13526
	NRS-123
	NR-46805
	NRS-662
	ATCC BAA-1707
	ATCC 43300
	NRS-383
	NCTC-12493
	NRS-676
	NRS-678
	NRS-648
	NRS-651
	NRS-643
	NRS-484
	NRS-385
	NRS-384
	ATCC BAA-40
	ATCC 700698
	NRS-382
	NRS-659
	NRS-657
	NRS-655
	NRS-654
	NRS-647
	ATCC BAA-42
	ATCC BAA-41
	NRS-483
	NRS-675
	NRS-645
	NRS-687
	NRS-667
	NRS-677
	NRS-683
	NRS-688
	NRS-22
	NRS-387
	NRS-70
Staphylococcus aureus
(mecA+)	ATCC 33591
Staphylococcus aureus
(mecC+)	ATCC BAA-2312
	ATCC BAA-2313
Staphylococcus epidermidis	ATCC 12228
	ATCC 49134
Staphylococcus epidermidis	NCIMB-8853
	ATCC 700583
	ATCC 14990
Staphylococcus epidermidis
(mecA+)	ATCC 35983
	ATCC 35984

54

Organism	Strain
Enterococcus faecium (vanA+)	ATCC 49224
	ATCC BAA-2846
	ATCC 19953
	ATCC 27270
	ATCC 35667
	ATCC BAA-2316
	ATCC BAA-2317
	ATCC 700221
	ATCC BAA-2319
	ATCC BAA-2320
	LMC 003921
	LMC 103676
Enterococcus faecium (vanA+)	LMC 089524
	LMC 104266
	LMC 032261
	LMC 110371
	LMC 002867
	LMC 055971
	ATCC 51559
	ATCC BAA-2318
Enterococcus faecium (vanB+)	ATCC 51858
	ATCC 49573
	ATCC 49609
Enterococcus gallinarum	ATCC 49610
	ATCC 700425
	ATCC 49608
Enterococcus hirae	ATCC 49479
	ATCC 10541
Enterococcus italicus	CCUG 47860
Enterococcus malodoratus	ATCC 43197
Enterococcus pseudoavium	CCUG 33310T
Enterococcus raffinosus	ATCC 49464
Enterococcus saccharolyticus	ATCC 43076
Enterococcus sanguinicola	DSM-21767
Enterococcus faecalis
	ATCC 51575
	ATCC 700802
Enterococcus faecalis	ATCC 10100
	ATCC 12399
	ATCC 14506
	ATCC 33186
	ATCC 49532
Enterococcus faecalis	ATCC 49533
	ATCC 7080
	ATCC 49474
	ATCC 49332
Enterococcus faecalis	ATCC 29200
	ATCC BAA-2128
	ATCC 51188
Organism	Strain
	ATCC 29887
	ATCC 49461
	ATCC 700565
	ATCC 51625
Staphylococcus lugdunensis
	NRS-879
Staphylococcus lugdunensis	ATCC 49576
	NRS-878
	NRS-880
Streptococcus	ATCC 12401
	ATCC 13813
	ATCC 12386
Streptococcus agalactiae	ATCC 12973
	ATCC 27956
	NCTC-8017
	ATCC 12403
	ATCC 9895
Streptococcus anginosus	ATCC 33397
	NCTC-10713
Streptococcus bovis	ATCC 33317
	ATCC 35034
Streptococcus constellatus	ATCC 27513
Streptococcus criceti	ATCC 19642c
	ATCC 35666
Streptococcus dysgalactiae	ATCC 43078
	ATCC 12394
Streptococcus equi	ATCC 43079
	ATCC 9528
	ATCC 15351
Streptococcus equinus	ATCC 9812
	ATCC 49475
Streptococcus gallolyticus	ATCC 9809
	ATCC 43144
Streptococcus gordonii	ATCC 10558
	ATCC 35557
	ATCC BAA-102
Streptococcus infantarius	ATCC BAA-103
	ATCC BAA-2089
Streptococcus infantis	ATCC 700779
Streptococcus intermedius	ATCC 27335
Streptococcus mitis	ATCC 15914
	ATCC 6249
	ATCC 49456
Streptococcus mitis	NCIMB-13770
Streptococcus oralis	ATCC 35037
Streptococcus oralis	ATCC 55229
Streptococcus parasanguinis	ATCC 15909
Streptococcus peroris	ATCC 700780

Confidential

Page 51

55

Organism	Strain
Enterococcus faecalis	ATCC 49149
	NCTC-775
	ATCC 19433
	ATCC 49452
Enterococcus faecalis (vanA+)	JMI 876745
Enterococcus faecalis (vanB+)	ATCC BAA-2365
Enterococcus faecium	ATCC 51299
Enterococcus faecium	ATCC 19434
	ATCC 23828
	ATCC 27273
	ATCC BAA-2127
	ATCC 6057
	ATCC 49624
	ATCC 6569
	ATCC BAA-472
	ATCC 9756
	ATCC 49224
Enterococcus faecium	ATCC BAA-2846
	ATCC 19953
	ATCC 27270
	ATCC 35667
Enterococcus faecium (vanA+)	ATCC BAA-2316
Enterococcus faecium (vanA+)	ATCC BAA-2317
Enterococcus faecium (vanA+)	ATCC 700221
	ATCC BAA-2319
	ATCC BAA-2320
	LMC 003921
	LMC 103676
	LMC 089524
	LMC 104266
	LMC 032261
Enterococcus faecium (vanA+)	LMC 110371
	LMC 002867
	LMC 055971
	ATCC 51559
Enterococcus faecium (vanA+)	ATCC BAA-2318
Enterococcus faecium (vanB+)	ATCC 51858
Lactobacillus casei	ATCC 334
Organism	Strain
Streptococcus pneumoniae	ATCC BAA-475
	ATCC 10357
	ATCC 49619
	ATCC 49136
	ATCC BAA-659
	ATCC 6315
	ATCC BAA-1667
	ATCC 700674
	ATCC 6321
	ATCC 700673
	ATCC 51916
	ATCC 8338
	ATCC 6301
	ATCC 8335
	NCIMB-13286
Streptococcus pyogenes	ATCC BAA-1656
	ATCC 12384
	ATCC 49399
	ATCC 12344
	ATCC 19615
	NCIMB-13285
	ATCC 14289

Streptococcus salivarius	ATCC 13419c
	ATCC 7073
Streptococcus salivarius	ATCC 25975
	ATCC 31067c
Streptococcus sanguinis	ATCC 10556
Streptococcus thoraltensis	ATCC 700865
Streptococcus agalactiae	ATCC 12401
	ATCC 13813
	ATCC 12386
	ATCC 12973
	ATCC 27956
	NCTC-8017
	ATCC 12403
Streptococcus anginosus group
Streptococcus anginosus	ATCC 9895
	ATCC 33397
NCTC-10713
Streptococcus constellatus	ATCC 27513

56

Organism	Strain
Lactobacillus paracasei	ATCC 39392
	ATCC 25598
	ATCC BAA-52
	ATCC 27092
Lactobacillus rhamnosus	ATCC 39595
	ATCC 53103
	ATCC 55915
Lactobacillus zeae	ATCC 15820
Listeria
Listeria innocua	NCTC-11288
	ATCC 33090
Listeria ivanovii	ATCC 19119
	ATCC BAA-139
	ATCC 700402
Listeria monocytogenes	ATCC 10890
	ATCC 19111
	ATCC 13932
	ATCC 19114
	ATCC 7644
	ATCC 19112
	ATCC BAA-751
	ATCC 19118
Listeria seeligeri	ATCC 19115
Listeria welshimeri	ATCC 35967
Listeria monocytogenes	ATCC 35897
Listeria monocytogenes	ATCC 10890
Listeria monocytogenes	ATCC 19111
Listeria monocytogenes	ATCC 13932
Listeria monocytogenes	ATCC 19114
Listeria monocytogenes	ATCC 7644
Listeria monocytogenes	ATCC 19112
Listeria monocytogenes	ATCC BAA-751
Listeria monocytogenes	ATCC 19118
Listeria monocytogenes	ATCC 19115
Micrococcus
	ATCC 19212
	ATCC 10240
Micrococcus luteus	ATCC 400
	ATCC 53598
	ATCC 49732
	ATCC 4698
Micrococcus lylae	ATCC 27566
Micrococcus yunnanensis	ATCC 7468
Staphylococcus

Staphylococcus arlettae	ATCC 43957
Staphylococcus aureus	ATCC 25923
	ATCC 29247
Organism	Strain
Streptococcus intermedius	ATCC 27335
Streptococcus pneumoniae	ATCC BAA-475
Streptococcus pneumoniae	ATCC 10357
	ATCC 49619
	ATCC 49136
	ATCC BAA-659
	ATCC 6315
	ATCC BAA-1667
	ATCC 700674
	ATCC 6321
	ATCC 700673
	ATCC 51916
	ATCC 8338
	ATCC 6301
	ATCC 8335
	NCIMB-13286
Streptococcus pyogenes	ATCC BAA-1656
	ATCC 12384
	ATCC 49399
	ATCC 12344
Streptococcus pyogenes	ATCC 19615
	NCIMB-13285
	ATCC 14289
Pan Candida	ATCC 24433
	ATCC MYA-4441
Candida albicans	ATCC 14053
Candida albicans	ATCC 90028
	ATCC 66032
	ATCC 15126
Candida glabrata	ATCC MYA-2950
	ATCC 2001
Candida krusei	ATCC 34135
	ATCC 32196
	ATCC 14243
	ATCC 90018D
Candida parapsilosis	ATCC 58895
	ATCC 22019
Pan Gram-Negative
Acinetobacter baumannii	NCTC-13302
	NCTC-13422
Acinetobacter haemolyticus	ATCC 19002
Acinetobacter junii	ATCC 17908
Acinetobacter lwoffii	ATCC 15309
Acinetobacter ursingii	ATCC BAA-617
Bacteroides fragilis	NCTC-9343

57

Organism	Strain	Organism	Strain
	ATCC 6538P	Burkholderia cepacia	ATCC 25416
	ATCC 29213	Cedecea davisiae	ATCC 43025
	NR-45889	Citrobacter freundii	NCTC-9750
	NR-45890	Citrobacter koseri	ATCC 27156
	NR-46074	Cronobacter muytjensii	ATCC 51329
	NR-45881	Cronobacter sakazakii	ATCC 12868
	NR-46411	Edwardsiella tarda	ATCC 15947
	NR-46414	Enterobacter aerogenes	ATCC 13048
	NR-46418	Enterobacter amnigenus	ATCC 51816
	NR-46417	Enterobacter asburiae	ATCC 35953
	NR-13524		ATCC 13047
	NR-13527		ATCC 23373
	NR-13525	Enterobacter cloacae	ATCC 23355
	NR-13526		ATCC 35030
	NRS-123	Enterobacter hormaechei	ATCC 700322
	NR-46805	Erwinia aphidicola	ATCC 27991
Staphylococcus aureus (mecA+)	NRS-662		ATCC 4157
	ATCC BAA-1707		ATCC 14948
	ATCC 43300	Escherichia coli	ATCC 25922
	NRS-383		ATCC BAA-
	NCTC-12493	Escherichia fergusonii	ATCC 35469
	NRS-676	Escherichia hermannii	ATCC 700368
	NRS-678	Escherichia vulneris	ATCC 33821
	NRS-648	Fusobacterium necrophorum	ATCC 25286
	NRS-651	Fusobacterium nucleatum	ATCC 25586
	NRS-643	Haemophilus influenzae	ATCC 10211
	NRS-484		ATCC 49144
	NRS-385		ATCC 43065
Staphylococcus aureus (mecA+)	NRS-384	Haemophilus influenzae	NCTC-8468
	ATCC BAA-40	Haemophilus parainfluenzae	ATCC 9796
	ATCC 700698	Hafnia alvei	ATCC 51815
	NRS-382		ATCC 700324
	NRS-659	Klebsiella oxytoca	ATCC 43165
	NRS-657		ATCC 43863
	NRS-655	Klebsiella ozaenae	ATCC 11296
	NRS-654		ATCC BAA-
	NRS-647		NCTC-9633
Staphylococcus aureus (mecA+)	ATCC BAA-42	Klebsiella pneumoniae	NCTC-13440
	ATCC BAA-41		ATCC 51503
	NRS-483	Kluyvera ascorbata	ATCC 14236
	NRS-675	Kluyvera cryocrescens	ATCC 14240

58

Organism	Strain
	NRS-645
	NRS-687
	NRS-667
	NRS-677
	NRS-683
	NRS-688
	NRS-22
	NRS-387
	NRS-70
	ATCC 33591
Staphylococcus aureus (mecC+)	ATCC BAA-2312
	ATCC BAA-2313
Staphylococcus auricularis	ATCC 33750
	ATCC 33753
Staphylococcus capitis	ATCC 27840
	NRS-866
	ATCC 35661
Staphylococcus caprae	ATCC 51548
Staphylococcus carnosus	ATCC 51365
Staphylococcus chromogenes	ATCC 43764
Staphylococcus cohnii	ATCC 29974
	ATCC 12228
	ATCC 49134
Staphylococcus epidermidis	NCIMB-8853
	ATCC 700583
	ATCC 14990
	ATCC 35983
	ATCC 35984
	ATCC 29887
Staphylococcus epidermidis
(mecA+)	ATCC 49461
	ATCC 700565
	ATCC 51625
Staphylococcus gallinarum	ATCC 700401
	ATCC 35539
Staphylococcus haemolyticus	ATCC 29970
	ATCC 31874
Staphylococcus haemolyticus
(mecA+)	NRS-62
	ATCC BAA-1693
	NRS-69
Organism	Strain
Legionella pneumophila	ATCC 33823
Moraxella catarrhalis	ATCC 23246
Moraxella nonliquefaciens	ATCC 17953
Moraxella osloensis	ATCC 10973
Morganella morganii	ATCC 25829
Neisseria lactamica	ATCC 23970
Neisseria meningitidis	ATCC 13090
	ATCC 13113
	ATCC 13077
	ATCC 13102
Neisseria mucosa	ATCC 19695
Neisseria sicca	ATCC 29193
Pantoea agglomerans	ATCC 14537
Pasteurella aerogenes	ATCC 27883
Proteus mirabilis	ATCC 43071
	CDC#0155
	CDC#0159
Proteus penneri	ATCC 35197
Proteus vulgaris	ATCC 6380
Providencia alcalifaciens	ATCC 9886
Providencia rettgeri	ATCC 9919
Providencia stuartii	ATCC 33672
Pseudomonas aeruginosa	ATCC 15442
	NCIMB-12469
	ATCC 10145
Pseudomonas fluorescens	ATCC 13525
Pseudomonas luteola	ATCC 35970
Pseudomonas putida	ATCC 31483
Raoultella terrigena	ATCC 55553
Salmonella bongori	ATCC 43975
Salmonella enterica subsp. enterica	ATCC 51957
Salmonella enterica Choleraesuis	ATCC 12011
Salmonella enterica Paratyphi	FSL S5-0447
Salmonella typhi	ATCC 19430
Serratia fonticola	ATCC 29844
Serratia liquefaciens	ATCC 27592
Serratia marcescens	ATCC 8100
	ATCC 14756
	ATCC 13880
Serratia odorifera	ATCC 33077

Page 55

59

Organism	Strain
	NRS-870
	ATCC 27844
Staphylococcus hominis
(mecA+)	ATCC 700237
	ATCC 700236
Staphylococcus hyicus	ATCC 11249
Staphylococcus intermedius	ATCC 29663
	ATCC 49052

Organism	Strain
Serratia rubidaea	ATCC 27593
Shigella boydii	ATCC 9207
Shigella dysenteriae	ATCC 13313
Shigella sonnei	ATCC 29930
Stenotrophomonas maltophilia	ATCC 13636
Tatumella ptyseos	ATCC 33302
Yersinia enterocolitica subsp.
Enterocolitica	ATCC 9610

^A Detected at 2 x 10^6 CFU/mL

^ Detected at 2 x 10°CFU/mL
B Detected at 2 x 10°CFU/mL
C Detected at 2 x 10°CFU/mL
C Detected at 2 x 10°CFU/mL

Detected at 4 x 10⁶ CFU/mL
Detected at 1 x 10⁷ CFU/L

C Detected at 4 x 108 CFU/mL

り Detected at 1 x 107 CFU/mL

60

Predicted (in silico) Reactivity for Genus and Group Assays

Note: the performance of the ePlex BCID-GP Panel has not been established for all of the organisms listed in the tables below. See the Analytical Reactivity (Inclusivity) and Limit of Detection (Analytical Sensitivity) sections for data on organisms for which performance characteristics have been established (indicated with an asterisk in Tables 46-57). Some species were not assessed in silico due to lack of sequence data, though they may appear in the analytical sensitivity or specificity studies.

In addition to species-specific assays, the ePlex BCID-GP Panel contains a number of broader genus or group-level assays; including Bacillus cereus group, Bacillus subtilis group, Corynebacterium, Enterococcus, Lactobacillus, Listeria, Micrococcus, Staphylococcus, Streptococcus, Streptococcus anginosus group, Pan Candida and Pan Gram-Negative assays. Tables 46-57 summarize the predicted (in silico) reactivity (inclusivity) for these assay targets.

Detection Predicted for ≥95% of target sequences
Bacillus thuringiensis*	Bacillus toyonensis	Bacillus weihenstephanensis
Detection Predicted for 85%-94% of target sequences
Bacillus cereus*
Detection Predicted for