BioFire Blood Culture Identification 2 (BCID2) Panel

{0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ## DECISION SUMMARY ASSAY ONLY ### I Background Information: #### A 510(k) Number K193519 #### B Applicant BioFire Diagnostics, LLC #### C Proprietary and Established Names BioFire Blood Culture Identification 2 (BCID2) Panel BioFire BCID2 Panel BCID2 Panel #### D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | PAM | Class II | 21 CFR 866.3365 - Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures | MI - Microbiology | ### II Submission/Device Overview: #### A Purpose for Submission: To obtain a substantial equivalence determination for the for the BioFire Blood Culture Identification 2 (BCID2) Panel. #### B Measurand: Gram Positive Bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp. (with specific differentiation of Staphylococcus aureus, Staphylococcus epidermidis, and Staphylococcus lugdunensis), Streptococcus spp. (with specific differentiation of Streptococcus Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} agalactiae (Group B), Streptococcus pneumoniae, and Streptococcus pyogenes (Group A)) Gram-negative Bacteria: Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Enterobacterales (with specific differentiation of Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., and Serratia marcescens) Yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gatti Resistance Markers: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B and VIM ### C Type of Test: A multiplexed nucleic acid-based test intended for use with the FilmArray 2.0 or FilmArray Torch systems for the qualitative in vitro detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. The BCID2 Panel is performed directly on positive blood culture samples identified as positive by a continuous monitoring blood culture system. ### III Intended Use/Indications for Use: ### A Intended Use(s): See Indications for Use below. ### B Indication(s) for Use: The BioFire Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with FilmArray 2.0 or FilmArray Torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following organism types and subtypes are identified using the BioFire BCID2 Panel: Gram Positive Bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp. (with specific differentiation of Staphylococcus aureus, Staphylococcus epidermidis, and Staphylococcus lugdunensis), Streptococcus spp. (with specific differentiation K193519 - Page 2 of 105 {2} of Streptococcus agalactiae (Group B), Streptococcus pneumoniae, and Streptococcus pyogenes (Group A)) Gram Negative Bacteria: Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Enterobacterales (with specific differentiation of Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., and Serratia marcescens) Yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gatti The BioFire BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA/C and mecA/C in conjunction with MREJ), vancomycin (vanA and vanB), β-lactams including penicillins, cephalosporins, monobactams, and carbapenems (blaCTX-M, blaIMP, blaKPC, blaNDM, blaOXA48-like, blaVIM) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized colistin genetic determinant mcr-1, an emerging marker of public health importance. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, β-lactams, and colistin exist. Antimicrobial Resistance Genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B and VIM The BioFire BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel. The BioFire BCID2 Panel is not intended to monitor treatment for blood stream infection. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the BioFire BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BioFire BCID2 Panel assays. ### C Special Conditions for Use Statement(s): Rx - For Prescription Use Only ### D Special Instrument Requirements: For use with the FilmArray 2.0 or FilmArray Torch systems ### IV Device/System Characteristics: ### A Device Description: K193519 - Page 3 of 105 {3} The BioFire Blood Culture Identification 2 (BCID2) Panel is designed to simultaneously identify 43 bacteria, yeast, and select genetic determinants of antimicrobial resistance. The BioFire BCID2 Panel is performed directly on positive blood culture samples. BioFire BCID2 Panel is compatible with BioFire's PCR-based in vitro diagnostic FilmArray 2.0 and FilmArray Torch systems for infectious disease testing. A specific software module (i.e., BioFire BCID2 Panel Pouch Module) is used to perform BioFire BCID2 Panel testing on these systems. ### B Principle of Operation: A test is initiated by loading Hydration Solution into one port of the FilmArray pouch and positive blood culture specimen mixed with the provided Sample Buffer into the other port of the BioFire BCID2 Panel pouch and placing it in a FilmArray instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray Software guides the user through the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run. The FilmArray instruments contain coordinated systems of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically-controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis. Nucleic acid extraction occurs within the FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the FilmArray performs a nested multiplex PCR that is executed in two stages. During the first stage, the FilmArray performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double-stranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data. 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 on the panel. ### V Substantial Equivalence Information: K193519 - Page 4 of 105 {4} # A Predicate Device Name(s): FilmArray Blood Culture Identification (BCID) Panel # B Predicate 510(k) Number(s): K181493 # C Comparison with Predicate(s): | Device & Predicate Device(s): | K193519 | K181493 | | --- | --- | --- | | Device Trade Name | BioFire Blood Culture Identification 2 (BCID2) Panel | FilmArray Blood Culture Identification (BCID) Panel | | General Device Characteristic Similarities | | | | Intended Use/ Indications for Use | The BioFire Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with FilmArray 2.0 or FilmArray Torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following organism types and subtypes are identified using the BioFire BCID2 Panel: Gram-positive Bacteria: *Enterococcus faecalis*, *Enterococcus faecium*, *Listeria monocytogenes*, *Staphylococcus* spp. (with specific differentiation of *Staphylococcus aureus*, *Staphylococcus epidermidis*, and *Staphylococcus lugdunensis*), *Streptococcus* spp. (with specific differentiation of *Streptococcus agalactiae* (Group B), *Streptococcus pneumoniae*, and *Streptococcus pyogenes* (Group A)) Gram-negative Bacteria: *Acinetobacter calcoaceticus-baumannii* complex, *Bacteroides fragilis*, *Haemophilus influenzae*, *Neisseria meningitidis* (encapsulated), *Pseudomonas aeruginosa*, *Stenotrophomonas maltophilia*, *Enterobacterales* (with specific differentiation of *Enterobacter cloacae* | The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based *in vitro* diagnostic test intended for use with FilmArray systems. The FilmArray BCID Panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. The FilmArray BCID Panel assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: *Enterococci*, *Listeria monocytogenes*, *Staphylococci* (including specific differentiation of *Staphylococcus aureus*), *Streptococci* (with specific differentiation of *Streptococcus agalactiae*, *Streptococcus pneumoniae*, and *Streptococcus pyogenes*), *Acinetobacter baumannii*, *Enterobacteriaceae* (including specific differentiation of the *Enterobacter cloacae* complex, *Escherichia coli*, *Klebsiella oxytoca*, *Klebsiella pneumoniae*, *Proteus*, and *Serratia marcescens*), *Haemophilus influenzae*, *Neisseria meningitidis* (encapsulated), *Pseudomonas aeruginosa*, *Candida albicans*, *Candida glabrata*, *Candida krusei*, *Candida parapsilosis*, and *Candida tropicalis*. | K193519 - Page 5 of 105 {5} | Device & Predicate Device(s): | K193519 | K181493 | | --- | --- | --- | | | *complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae* group, *Proteus* spp., *Salmonella* spp., and *Serratia marcescens*) Yeast: *Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis*, and *Cryptococcus neoformans/gatti* The BioFire BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (*mecA/C* and *mecA/C* in conjunction with MREJ), vancomycin (*vanA* and *vanB*), β-lactams including penicillins, cephalosporins, monobactams, and carbapenems (_{bla}CTX-M, _{bla}IMP, _{bla}KPC, _{bla}NDM, _{bla}OXA48-like, _{bla}VIM) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized genetic determinant *mcr-1*, an emerging marker of public health importance. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, β-lactams, and colistin exist. Antimicrobial Resistance Genes: CTX-M, IMP, KPC, *mcr-1*, *mecA/C*, *mecA/C* and MREJ (MRSA), NDM, OXA-48-like, *vanA/B*, VIM The BioFire BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel. The BioFire BCID2 Panel is not intended to monitor treatment for blood stream infection. Subculturing of positive blood cultures is | The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (*mecA*), vancomycin (*vanA* and *vanB*), and carbapenems (_{bla}KPC) 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. Negative results for these select antimicrobial resistance gene assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, and carbapenems exist. The FilmArray BCID Panel 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. Positive FilmArray results do not rule out co-infection with organisms not included in the FilmArray BCID Panel. The FilmArray BCID Panel is not intended to monitor treatment for bacteremia or fungemia. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the FilmArray BCID Panel, and for species determination of some *Staphylococci*, *Enterococci*, *Streptococci*, and *Enterobacteriaceae* that are not specifically identified by the FilmArray BCID Panel assays. | K193519 - Page 6 of 105 {6} | Device & Predicate Device(s): | K193519 | K181493 | | --- | --- | --- | | | necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the BioFire BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BioFire BCID2 Panel assays. | | | Specimen Type | Blood culture samples identified as positive by a continuous monitoring blood culture system. | Same | | Analyte | DNA | Same | | Technological Principles | Highly-multiplexed nested nucleic acid amplification test with melt analysis | Same | | Instrumentation | FilmArray 2.0 or FilmArray Torch | FilmArray, FilmArray 2.0, or FilmArray Torch | | Time to result | About 1 hour | Same | | Reagent Storage | Room temperature | Same | | Test Interpretation | Automated test interpretation and report generation. User cannot access raw data. | Same | | Controls | Two controls are included in each reagent pouch to control for sample processing and both stages of PCR and melt analysis. | Same | | User Complexity | Moderate/Low | Same | | **General Device Characteristic Differences** | | | | Organisms Detected | Gram-positive Bacteria *Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus* spp. (with specific differentiation of *Staphylococcus aureus, Staphylococcus epidermidis*, and *Staphylococcus lugdunensis*), *Streptococcus* spp. (with specific differentiation of *Streptococcus agalactiae* (Group B), *Streptococcus pneumoniae*, and *Streptococcus pyogenes* (Group A)) Gram-negative Bacteria *Acinetobacter calcoaceticus-baumannii* complex, *Bacteroides* | Gram-positive Bacteria *Enterococcus* spp., *Listeria monocytogenes, Staphylococcus* spp.(including specific differentiation of *Staphylococcus aureus*), *Streptococcus* spp. (with specific differentiation of *Streptococcus agalactiae, Streptococcus pneumoniae*, and *Streptococcus pyogenes*) Gram-negative Bacteria *Acinetobacter baumannii, Enterobacteriaceae* (including specific | K193519 - Page 7 of 105 {7} | Device & Predicate Device(s): | K193519 | K181493 | | --- | --- | --- | | | *fragilis, Haemophilus influenzae, Neisseria meningitidis* (encapsulated), *Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Enterobacterales* (with specific differentiation of *Enterobacter cloacae* complex, *Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae* group, *Proteus* spp., *Salmonella* spp., and *Serratia marcescens*) Yeast *Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis*, and *Cryptococcus neoformans/gatti* Antimicrobial Resistance Genes CTX-M, IMP, KPC, *mcr-1, mecA/C, mecA/C* and MREJ (MRSA), NDM, OXA-48-like, *vanA/B*, VIM The BioFire BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel. The BioFire BCID2 Panel is not intended to monitor treatment for blood stream infection. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not detected by the BioFire BCID2 Panel, and for determination of species detected but not identified within complexes, groups, or genera by the BioFire BCID2 Panel assays. | differentiation of the *Enterobacter cloacae* complex, *Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus*, and *Serratia marcescens*), *Haemophilus influenzae, Neisseria meningitidis* (encapsulated), *Pseudomonas aeruginosa* Yeast *Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis* Antimicrobial Resistance Genes *mecA* (detects *mecA* and *mecC*), *vanA/B*, and KPC | ### VI Standards/Guidance Documents Referenced: General K193519 - Page 8 of 105 {8} - Guidance for Industry and Food and Drug Administration Staff – Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices, (August 27, 2014) - Guidance for Industry and Food and Drug Administrative Staff – Class II Special Control Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures (May 27, 2015) - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, FDA Guidance Document (March 13, 2007) - User Protocol for Evaluation of Qualitative Test Performance, Clinical and Laboratory Standards Institute (CLSI) Approved Guideline – Second Edition, EP12-A2 (January 2008) - Molecular Diagnostic Methods for Infectious Diseases, Clinical and Laboratory Standards Institute (CLSI) Approved Guideline, MM3-A2 (February 2006) - Interference Testing in Clinical Chemistry, 3rd Edition, Clinical and Laboratory Standards Institute (CLSI) Approved Guideline, EP07 (April 2018) # Software - Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) - Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff (September 27, 2019) General Principle of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002) - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff (October 18, 2018) # Labeling - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, FDA - Guidance Document (November 30, 2004) - Guidance for Industry and FDA on Alternative to Certain Prescription Device Labeling Requirements (January 1, 2000) # FDA-recognized Standards - ISO 14971:2007 'Medical devices – Application of risk management to medical devices' - EN 62366:2008/IEC 62366-1:2015, 'Medical device – Application of usability engineering to medical devices' - EN 13612:2002, 'Performance evaluation of in vitro diagnostic devices' - ISO 62304:2006, 'Medical device software – Software life-cycle processes' – IEC 62304:2006, November 27, 2008 - ISO 15223-1:2012, 'Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements' # VII Performance Characteristics (if/when applicable): # A Analytical Performance: K193519 - Page 9 of 105 {9} # 1. Precision/Reproducibility: A multi-center study was performed to evaluate the reproducibility of analyte detection on the FilmArray 2.0 and FilmArray Torch systems. The study incorporated potential variation introduced by site (three), day (five), operator (at least two per site), system/module, and reagent kit lot (three). The contrived samples contained representative isolates of aerobic and anaerobic gram-positive and gram-negative bacteria, AMR genes, and yeast in simulated blood culture matrix. Each organism was present in a sample at a concentration consistent with what is observed in a positive blood culture (at positive bottle indication or up to 24 hours after positive bottle indication). Negative results were obtained from samples that were not spiked with the organism or AMR gene. Each of the three sites tested 20 replicates per sample and system for a total of 120 valid runs per sample and 720 valid runs overall. A summary of the reproducibility of results (percent (%) agreement with the expected Detected, Not Detected or N/A result) for each analyte (by site and system) is provided in Table 1. Table 1: Reproducibility of the BioFire BCID2 Panel Results on FilmArray 2.0 and FilmArray Torch Systems | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | **Gram Positive Bacteria** | | | | | | | | | | | | | *Enterococcus faecalis* ATCC 51299 | 7.65E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Enterococcus faecium* ATCC 27270 | 9.19E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Listeria monocytogenes* | Negative (no analyte) | Not Detected | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 720/720 100% [99.5%- 100%] | | *Staphylococcus spp.* | Multiple^{a} | Detected | 59/60 (98.3%) | 60/60 (100%) | 60/60 (100%) | 179/180 (99.4%) | 60/60 (100%) | 60/60 (100%) | 60/60 (100%) | 180/180 (100%) | 359/360 99.7% [98.5%- 99.9%] | K193519 - Page 10 of 105 {10} | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | | Negative (no analyte) | Not Detected | 60/60 (100%) | 60/60 (100%) | 60/60 (100%) | 180/180 (100%) | 60/60 (100%) | 60/60 (100%) | 60/60 (100%) | 180/180 (100%) | 360/360 100% [99.0%-100%] | | Staphylococcus aureus ATCC BAA-38 | 2.44E+08 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4-99.9%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Staphylococcus epidermidis ATCC 12228 | 2.31E+06 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 19/20 (95.0%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4-99.9%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Staphylococcus lugdunensis ATCC 43809 | 1.67E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%-100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/10 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Streptococcus spp. | Multipleb | Detected | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | 240/240 100% [98.4%-100%] | | | Negative (no analyte) | Not Detected | 80/80 (100%) | 80/80 (100%) | 80/80 (100%) | 240/240 (100%) | 80/80 (100%) | 80/80 (100%) | 80/80 (100%) | 240/240 (100%) | 480/480 100% [99.2%-100%] | | Streptococcus agalactiae | Negative (no analyte) | Not Detected | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 720/720 100% [99.5%-100%] | | Streptococcus pneumoniae ATCC 6303 | 5.91E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%-100%] | K193519 - Page 11 of 105 {11} | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Streptococcus pyogenes ATCC 49399 | 2.63E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%-100%] | | | None (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Gram Negative Bacteria | | | | | | | | | | | | | Acinetobacter calcoaceticus-baumannii complex (Acinetobacter baumannii) AR Bank 0033 | 7.36E+07 CFU/mL | Detected | 19/20 (95.0%) | 19/20 (95.0%) | 20/20 (100%) | 58/60 (96.7%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 118/120 98.3% [94.1%-99.8%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Bacteroides fragilis ATCC 25285 | 8.62E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [99.4%-100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Enterobacterales | Multiple\( ^c \) | Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | | Negative (no analyte) | Not Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%-100%] | | Enterobacter cloacae complex | Negative (no analyte) | Not Detected | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 720/720 100% [99.5%-100%] | | Escherichia coli CDC-FDA AR Bank #0350 | 8.79E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 19/20 (95.0%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4%-99.9%] | K193519 - Page 12 of 105 {12} | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Klebsiella aerogenes* **CDC-FDA AR** **Bank #0161** | 9.29E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Klebsiella oxytoca* **CDC-FDA AR** **Bank #0147** | 2.44E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Klebsiella pneumoniae* **group** | Negative (no analyte) | Not Detected | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 720/720 100% [99.5%- 100%] | | *Proteus spp.* *(Proteus mirabilis)***GRE 1254053** | 1.68E+09 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Salmonella spp.* *(Salmonella enterica)* **ATCC 700720** | 1.74E+09 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Serratia marcescens* **GRE 1659004** | 3.05E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | K193519 - Page 13 of 105 {13} | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Haemophilus influenzae ATCC 10211 | 1.32E+08 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [99.4%-99.9%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Neisseria meningitidis | Negative (no analyte) | Not Detected | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 720/720 100% [99.5%-100%] | | Pseudomonas aeruginosa CDC-FDA AR Bank #0054 | 7.22E+07 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4-99.9%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Stenotrophomonas maltophilia ATCC 700475 | 1.13E+09 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%-100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Antimicrobial Resistance Genes | | | | | | | | | | | | | CTX-M (CTX-M-22) (Proteus mirabilis) GRE 1254053 | 1.68E+09 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4%-99.9%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | IMP (IMP-4) (Klebsiella aerogenes) CDC- | 9.29E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%-100%] | K193519 - Page 14 of 105 {14} | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | *FDA AR Bank #0161* | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *KPC-3 (Klebsiella oxytoca) ATCC 10211* | 2.44E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *mcr-1 (Escherichia coli) CDC-FDA AR Bank #0350* | 8.79E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 19/20d (95.0%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4%- 99.9%] | | | Negative (no analyte) | Not Detected or N/A | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *mecA/C* | Negative (no analyte) | Not Detected or N/A | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 720/720 100% [99.5%- 100%] | | *mecA/C and MREJ (MRSA) (Staphylococcus aureus) ATCC BAA-38* | 2.44E+08 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4- 99.9%] | | | Negative (no analyte) | N/A | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *NDM (NDM-1)* | 7.36E+07 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4- 99.9%] | | *(Acinetobacter baumannii) CDC-FDA AR Bank #0033* | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *OXA-48-like (OXA-48)* | 3.05E+07 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4- 99.9%] | K193519 - Page 15 of 105 {15} | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | *(Serratia marcescens) GRE 1659004* | Negative (no analyte) | Not Detected or N/A | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *vanA/B (vanB) (Enterococcus faecalis) ATCC 51299* | 7.65E+08 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | N/A | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *VIM (VIM-4) (Pseudomonas aeruginosa) CDC-FDA AR Bank #0054* | 7.22E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [97.0%- 100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | **Yeast** | | | | | | | | | | | | | *Candida albicans ATCC 90028* | 1.76E+05 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 19/20 (95.0%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4%- 99.9%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Candida auris CDC-FDA AR Bank #0381* | 3.49E+07 CFU/mL | Detected | 19/20 (95.0%) | 20/20 (100%) | 20/20 (100%) | 59/60 (98.3%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 119/120 99.2% [95.4%- 99.9%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | | *Candida glabrata ATCC 15545* | 3.82E+07 CFU/mL | Detected | 20/20 (100%) | 18/20 (90.0%) | 20/20 (100%) | 58/60 (96.7%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 118/120 98.3% [94.1%- 99.8%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%- 100%] | K193519 - Page 16 of 105 {16} | Analyte (Type/Species) Source ID | Concentration Tested | Expected Result | Expected Result | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | FilmArray 2.0 | | | | FilmArray Torch | | | | All Sites/Systems [95% Confidence Interval] | | | | | Site A | Site B | Site C | System Total | Site A | Site B | Site C | System Total | | | Candida krusei ATCC 6258 | 2.48E+05 CFU/mL | Detected | 18/20 (90.0%) | 20/20 (100%) | 20/20 (100%) | 58/60 (96.7%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 118/120 98.3% [94.1%-99.8%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Candida parapsilosis ATCC 34136 | 2.91E+05 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [99.4%-100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Candida tropicalis | Negative (no analyte) | Not Detected | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 120/120 (100%) | 120/120 (100%) | 120/120 (100%) | 360/360 (100%) | 720/720 100% [99.5%-100%] | | Cryptococcus neoformans/gattii (Cryptococcus neoformans) ATCC MYA-4564 | 1.20E+07 CFU/mL | Detected | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 60/60 (100%) | 120/120 100% [99.4%-100%] | | | Negative (no analyte) | Not Detected | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) | 300/300 (100%) | 600/600 100% [99.4%-100%] | | Overall Agreement with the Expected Results (All Analytes/All Test Concentrations) [95% Confidence Interval] | | | 5148/5160 99.8% [99.6%-99.9%] | 5157/5160 99.9% [99.8%-99.9%] | 5157/5160 99.9% [99.8%-99.9%] | 15461/15480 99.9% [99.8%-99.9%] | 5160/5160 100% [99.9%-100%] | 5160/5160 100% [99.9%-100%] | 5160/5160 100% [99.9%-100%] | 15480/15480 100% [99.9%-100%] | 30941/30960 99.94% [99.90%-99.96%] | \( ^{a} \) Staphylococcus spp. data are from samples containing Staphylococcus aureus, Staphylococcus epidermidis, and Staphylococcus lugdunensis at the concentrations listed in their respective sections. \( ^{b} \) Streptococcus spp. data are from samples containing Streptococcus pneumoniae and Streptococcus pyogenes at the concentrations listed in their respective sections. \( ^{c} \) Enterobacterales data are from samples containing Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Proteus mirabilis, Salmonella enterica, and Serratia marcescens at the concentrations listed in their respective sections. \( ^{d} \) One replicate of the mcr-1 test result was reported as N/A. For this replicate, the MCR-1 assay was positive, but an applicable bacterium was not detected. ### 2. Linearity: Not Applicable ### 3. Analytical Specificity/Interference: K193519 - Page 17 of 105 {17} ### Analytical Reactivity (Inclusivity) The analytical reactivity of BioFire BCID2 Panel assays was assessed via a combination of in silico analysis of sequences available in public databases and testing of over 450 isolates representing the genetic, geographic, and temporal diversity of species, subspecies, and AMR gene types detected by the panel. Isolates were tested in triplicate at concentrations near LoD in simulated blood culture matrix. Results for each isolate tested as well as in silico reactivity predictions for species or AMR gene types that were not tested are shown in Table 2 – Table 44. For isolates that were not detected at the initial near-LoD concentration, additional testing was performed at higher concentrations and the approximate concentration where detection was observed is indicated. In most cases, the detected concentration was equal to or less than the concentration expected in a positive blood culture. Alternately, a Not Detected result is indicated if the isolate was not detected at a concentration equivalent to a positive blood culture level. Additional limitations on reactivity predicted by in silico sequence analysis are noted. Table 2: Results for Enterococcus faecalis Isolates Tested | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | | Enterococcus faecalis | ATCC 19433 | Type Strain | Enterococcus faecalis Detected | | | ATCC 29212 | Portland | | | | ATCC 49533 | UWH/1936 | | | | ATCC 51299 | NJ-3 | | | | ATCC 700802 | V583 | | | | ATCC BAA-2573 | bMx 0502240 | | | | JMI 12536 | MA/2002 | | Table 3: Results for Enterococcus faecium Isolates Tested | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | | Enterococcus faecium | ATCC 19434 | Type Strain | Enterococcus faecium Detected | | | ATCC 27270 | X3 [F] | | | | ATCC 51858 | Vancomycin-dependent #4 | | | | ATCC 700221 | - | | | | ATCC BAA-2318 | - | | | | JMI 475 | IN/2003 | | Table 4: Results for Listeria monocytogenes Isolates Tested | Organism | Serotype\( ^{a} \) | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Listeria monocytogenes | 1/2a | ATCC 15313 | Type StrainUnited Kingdom/1924 | Listeria monocytogenesDetected | | | | ATCC 19111 | Li 20United Kingdom | | | | 1/2b | ATCC BAA-751 | NSB 22072 | | | | 4b | ATCC 13932 | 1071/53 Germany | | | | | ATCC 43256 | CDC F2380 | | | | 7 | NCTC 10890 | Li 2482 Germany | | K193519 - Page 18 of 105 {18} \( ^{a} \) Assay reactivity is not serotype dependent, the assay will react with all serotypes (1/2a, 1/2b, 1/2c, 3a, 3b, 3c, 4a, 4b, 4c, 4d, 4e, and 7) Note: The BioFire BCID2 Panel may be able to detect strains of live, attenuated Listeria monocytogenes vaccines used in cancer immunotherapy. Table 5: Results for Staphylococcus spp. Isolates Tested and Predicted Reactivity for Species Not Tested | Organism | | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Staphylococcus argensis | | In silico prediction (not tested) | | Staphylococcus spp. Detected | | Staphylococcus arlettae | | ATCC 43957 | Type strain | | | Staphylococcus auricularis | | ATCC 33753 | Type strain | | | Staphylococcus capitis | ssp. capitis | ATCC 27842 | - | | | | ssp. urealyticus | ATCC 49326 | Type strain | | | Staphylococcus caprae | | ATCC 55133 | - | | | Staphylococcus carnosus | ssp. carnosus | ATCC 51365 | Type strain 1983 | | | Staphylococcus cohnii | ssp. cohnii | ATCC 29972 | - | | | | ssp. urealyticus | ATCC 49330 | Type strain | | | Staphylococcus condimenti | | CCUG 39902T | Type strain Japan | | | Staphylococcus cornubiensis | | In silico prediction (not tested) | | | | Staphylococcus delphini | | ATCC 49171 | Type strain Italy | | | Staphylococcus devriesei | | CCUG 58238T | Type Strain Belgium | | | Staphylococcus edaphicus | | In silico prediction (not tested) | | | | Staphylococcus epidermidis | | ATCC 35984 | Tennessee | | | Staphylococcus felis | | In silico prediction (not tested) | | | | Staphylococcus gallinarum | | ATCC 700401 | France | | | Staphylococcus haemolyticus | | ATCC 29968 | - | | | Staphylococcus hominis | ssp. hominis | ATCC 25615 | - | | | | ssp. novobiosepticus | ATCC 700236 | Type strain New Jersey1992 | | | Staphylococcus hyicus | | ATCC 11249 | Type strain | | | Staphylococcus intermedius | | ATCC 29663 | Type strain | | | Staphylococcus kloosii | | ATCC 43959 | Type strain USA | | | Staphylococcus lugdunensis | | ATCC 43809 | Type strain France | | | Staphylococcus lutrae | | ATCC 700373 | Type strain | | | Staphylococcus massiliensis | | CCUG 55927T | Type strain France 2005 | | | Staphylococcus microti | | In silico prediction (not tested) | | | | Staphylococcus nepalensis | | CCUG 66326 | Sweden 2014 | | | Staphylococcus pasteuri | | ATCC 51127 | France | | | Staphylococcus petrasii | ssp. jettensis | CCUG 62657T | Type strain Belgium | | K193519 - Page 19 of 105 {19} | Organism | | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | *Staphylococcus pettenkoferi* | | CCUG 70234 | Sweden 2017 | | | *Staphylococcus piscifermentans* | | *In silico* prediction (not tested) | | | | *Staphylococcus pseudintermedius* | | ATCC 49444 | - | | | *Staphylococcus pseudolugdunensis* | | *In silico* prediction (not tested) | | | | *Staphylococcus saccharolyticus* | | ATCC 14953 | Type strain | | | *Staphylococcus saprophyticus* | ssp. *saprophyticus* | ATCC 15305 | Type strain 1935 | | | *Staphylococcus schleiferi* | ssp. *coagulans* | ATCC 49545 | Type strain | | | | ssp. *schleiferi* | ATCC 43808 | Type strain France | | | *Staphylococcus sciuri* | ssp. *sciuri* | ATCC 29061 | - | | | *Staphylococcus simiae* | | GRE 1562010 | Type strain Czech Republic | | | *Staphylococcus simulans* | | ATCC 27848 | Type strain | | | *Staphylococcus stepanovicii* | | *In silico* prediction (not tested) | | | | *Staphylococcus warneri* | | ATCC 25614 | - | | | *Staphylococcus xylosus* | | ATCC 29966 | - | | | *Staphylococcus agnetis* | | *In silico* prediction (not tested) | | **Staphylococcus spp. Detected (≥5.9E+06 CFU/mL)** | | *Staphylococcus argenteus*^{a} | | DSM 28299 | Type strain Australia/2006 | | | *Staphylococcus aureus*^{a} | | Multiple isolates | - | | | *Staphylococcus chromogenes* | | ATCC 43764 | Type strain | | | *Staphylococcus sciuri* | ssp. *rodentium* | *In silico* prediction (not tested) | | | | *Staphylococcus succinus* | ssp. *succinus* | ATCC 700337 | Type strain Dominican Republic | | | *Staphylococcus schweitzeri*^{a} | | DSM 28300 | Type strain Gabon/2010 | | | *Staphylococcus vitulinus* | | ATCC 51145 | Type strain | | | *Staphylococcus equorum* | | ATCC 43958 | Type strain Belgium | **Not Detected** | | *Staphylococcus fleurettii* | | DSM 20047 | - | | | *Staphylococcus lentus* | | ATCC 29070 | Type strain France | | | *Staphylococcus muscae* | | *In silico* prediction (not tested) | | | | *Staphylococcus rostri* | | | | | $^{a}$ Also amplified by the *S. aureus* assay at lower concentrations. Will be reported as *Staphylococcus* spp. Detected and *Staphylococcus aureus* Detected Table 6: Results for *Staphylococcus aureus* Isolates Tested | Organism | | Source ID^{a} | Strain/Location/Year | PFGE Type/PVL (if known) | Result | | --- | --- | --- | --- | --- | --- | | *Staphylococcus aureus* | ssp. *anaerobius* | ATCC 35844 | MVF-7/Spain | unknown | **Staphylococcus aureus** **Detected** | | | ssp. *aureus* | ATCC 10832 | Wood 46 | unknown | | | | | ATCC 12600 | Type strain 1935 | unknown | | | | | ATCC 14154 | Rose | unknown | | K193519 - Page 20 of 105 {20} | Organism | | Source ID^{a} | Strain/Location/Year | PFGE Type/PVL (if known) | Result | | --- | --- | --- | --- | --- | --- | | | | ATCC 25923 | Seattle/1945 | unknown | | | | | ATCC 43300 | F182/Kansas | unknown | | | *Staphylococcus aureus* | NARSA NRS705 | NY-12 | USA 100 | | | | | | ATCC BAA-41 | New York/1994 | USA 100/PVL- | | | | | NARSA NRS701 | MN-082 | USA 200 | | | | | ATCC BAA-1720 | MRSA252 United Kingdom | USA 200 | | | | | ATCC BAA-1717 | TCH1516/Texas | USA 300 | | | | | NARSA NRS683 | GA-298 Georgia/2005 | USA 300/PVL+ | | | | | NARSA NRS662 | CO-34 | USA 300/PVL+ | | | | | NARSA NRS707 | NY-155 New York/2005 | USA 300/PVL+ | | | | | ATCC BAA-1707 | MW2 North Dakota/1998 | USA 400 | | | | | NARSA NRS691 | GA-62 | USA 500 | | | | | NARSA NRS385 | - | USA 500 | | | | | NARSA NRS648 | CA-347 | USA 600 | | | | | NARSA NRS689 | GA-442 | USA 700 | | | | | NARSA NRS668 | CO-72 Colorado/2005 | USA 800 | | | | | ATCC BAA-42 | HDE288 Portugal/1996 | USA 800 | | | | | ATCC BAA-1749 | 96:308 | USA 900 | | | | | ATCC BAA-1759 | N7129 | USA 900 | | | | | NARSA NRS745 | CA-629 | USA 1000 | | | | | BEI NR-46081 | HIP 12899 | USA 1100/PVL+ | | | | | ATCC BAA-1765 | 102-04 | USA 1200 | | | | | ATCC BAA-1700 | HFH-33798 Illinois/2004 | Not USA 100- 1100 | | | | | ATCC BAA-1691 | HFH-30137 Michigan/2003 | Not USA 100- 1100 | | | | | ATCC 29213 | Wichita | unknown | | | | | ATCC BAA-38 | E2125/Denmark | unknown | | | | | ATCC BAA-39 | HUSA304 Hungary/1993 | unknown | | | | | ATCC BAA-40 | CPS22 Portugal/1994 | unknown | | | | | ATCC BAA-44 | HPV107 Portugal/1996 | PVL- | | | | | ATCC BAA-2312 | M10/0061 Ireland/2010 | unknown | | | | | ATCC BAA-2313 | M10/0148 | unknown | | K193519 - Page 21 of 105 {21} | Organism | Source ID^{a} | Strain/Location/Year | PFGE Type/PVL (if known) | Result | | --- | --- | --- | --- | --- | | | | Ireland/2010 | | | | | ATCC BAA-2421 | Massachusetts/2010 | unknown | | | | ATCC BAA-2422 | Massachusetts/2010 | unknown | Staphylococcus aureus Detected | | | GRE 0759084 | - | unknown | | | | GRE 1055015 | - | unknown | | | | GRE 0860042 | - | unknown | | | | GRE 1052034 | - | unknown | | | | GRE 1151100 | - | unknown | | | | GRE 0960006 | - | unknown | | | | GRE 1055017 | - | unknown | | | | GRE 0759163 | - | unknown | | | | GRE 1062373 | - | unknown | | | | GRE 1057114 | - | unknown | | | | GRE 1062292 | - | unknown | | | | NARSA NRS686 | - | unknown | | | | Rennes 1060728 | - | unknown | | | | Sunnybrook SUN1 | Toronto | unknown | | | | GRE 1062264^{b} | - | unknown | Staphylococcus aureus Detected^{b} (≥6.3E+05 CFU/mL) | $^{a}$ NARSA and BEI isolates sourced by the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) for distribution by BEI Resources, NIAID, NIH $^{b}$ Isolate from private collection with variant sequence under assay primer(s). Similar variant sequences represent ~1% of over 10,000 S. aureus sequences evaluated Table 7: Results for Staphylococcus epidermidis Isolates Tested | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | | Staphylococcus epidermidis | ATCC 35984 | RP62A Tennessee | Staphylococcus epidermidis Detected | | | ATCC 12228 | FDA strain/PC1 1200 | | | | ATCC 29887 | 255-01B | | | | ATCC 35983 | RP12 Tennessee | | | | ATCC 51625 | CCF 15990 Ohio | | | | ATCC 700562 | 1191 Virginia/1997 | | K193519 - Page 22 of 105 {22} Table 8: Results for Staphylococcus lugdunensis Isolates Tested | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | | *Staphylococcus lugdunensis* | ATCC 43809 | Type strain France | *Staphylococcus lugdunensis* Detected | | | NCTC 7990 | Kelly United Kingdom/1949 | | | | ATCC 49576 | LRA/260.05.79 | | | | ATCC 700328 | 6733 | | | | ATCC 700582 | 7829 Virginia/1997 | | Table 9: Results for Streptococcus spp. Isolates Tested and Predicted Reactivity for Species Not Tested | Organism | | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | *Streptococcus acidominimus* | | *In silico* prediction (not tested) | | *Streptococcus* spp. Detected | | *Streptococcus agalactiae* | | ATCC 13813 | Type Strain | | | *Streptococcus anginosus* | | ATCC 33397 | Havil | | | *Streptococcus australis* | | ATCC 700641 | Type strain Australia/1987 | | | *Streptococcus azizii* | | *In silico* prediction (not tested) | | | | *Streptococcus bovimastitidis* | | *In silico* prediction (not tested) | | | | *Streptococcus bovis* | | ATCC 33317 | Pearl 11 | | | *Streptococcus caballi* | | *In silico* prediction (not tested) | | | | *Streptococcus canis* | | ATCC 43496 | Type strain Belgium/1982 | | | *Streptococcus castoreus* | | *In silico* prediction (not tested) | | | | *Streptococcus constellatus* | | ATCC 27513 | VPI 7712 | | | *Streptococcus criceti* | | *In silico* prediction (not tested) | | | | *Streptococcus cristatus* | | ATCC 51100 | Type strain United Kingdom | | | *Streptococcus cuniculi* | | *In silico* prediction (not tested) | | | | *Streptococcus devriesei* | | *In silico* prediction (not tested) | | | | *Streptococcus didelphis* | | *In silico* prediction (not tested) | | | | *Streptococcus downei* | | *In silico* prediction (not tested) | | | | *Streptococcus dysgalactiae* | ssp. *dysgalactiae* | ATCC 43078 | Type strain United Kingdom/1970 | | | | ssp. *equisimilis* | ATCC 12388 | Type strain United Kingdom/1970 | | | | ssp. *equisimilis* | NCTC 8543 | LRA 06 11 76 | | | *Streptococcus equinus* | | ATCC 9812 | Type strain | *Streptococcus* spp. Detected | | *Streptococcus ferus* | | *In silico* prediction (not tested) | | | | *Streptococcus gallolyticus* | ssp. *gallolyticus* | ATCC BAA-2069 | 2001 | | | | ssp. *pasteurianus* | ATCC 700338 | RG 1996 | | K193519 - Page 23 of 105 {23} | Organism | | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Streptococcus gordonii | | ATCC 10558 | Type strain | | | Streptococcus halotolerans | | In silico prediction (not tested) | | | | Streptococcus henryi | | In silico prediction (not tested) | | | | Streptococcus himalayensis | | In silico prediction (not tested) | | | | Streptococcus hongkongensis | | In silico prediction (not tested) | | | | Streptococcus hyointestinalis | | In silico prediction (not tested) | | | | Streptococcus ictaluri | | In silico prediction (not tested) | | | | Streptococcus infantarius | ssp. infantarius | ATCC BAA-102 | HDP 90056 | | | Streptococcus iniae | | In silico prediction (not tested) | | | | Streptococcus intermedius | | ATCC 27335 | 1877 | | | Streptococcus lactarius | | In silico prediction (not tested) | | | | Streptococcus lutetiensis | | In silico prediction (not tested) | | | | Streptococcus macacae | | In silico prediction (not tested) | | | | Streptococcus marimammalium | | In silico prediction (not tested) | | | | Streptococcus marmotae | | In silico prediction (not tested) | | | | Streptococcus massiliensis | | In silico prediction (not tested) | | | | Streptococcus merionis | | In silico prediction (not tested) | | | | Streptococcus milleri | | In silico prediction (not tested) | | | | Streptococcus minor\( ^{a} \) | | In silico prediction (not tested) | | | | Streptococcus mitis | | ATCC 49456 | Type strain | | | Streptococcus mutans | | ATCC 25175 | Type Strain | | | Streptococcus oligofermentans | | In silico prediction (not tested) | | | | Streptococcus oralis\( ^{a} \) | - | ATCC 10557 | SK2 | | | | ssp. tigurinus | DSM 24864 | Type strain Switzerland | | | Streptococcus orisasini | | In silico prediction (not tested) | | | | Streptococcus orisratti | | In silico prediction (not tested) | | | | Streptococcus ovis | | In silico prediction (not tested) | | | | Streptococcus parasanguinis | | ATCC 31412 | Si-1 | | | Streptococcus parasuis | | In silico prediction (not tested) | | | | Streptococcus parauberis | | In silico prediction (not tested) | | | | Streptococcus pasteurianus | | In silico prediction (not tested) | | | | Streptococcus penaeicida | | In silico prediction (not tested) | | | | Streptococcus peroris | | ATCC 700780 | Type strain Japan/1990 | | | Streptococcus phocae | | In silico prediction (not tested) | | | | Streptococcus pluranimalium | | In silico prediction (not tested) | | | | Streptococcus plurextorum | | In silico prediction (not tested) | | | | Streptococcus pneumoniae | | ATCC 33400 | Type strain | | | Streptococcus porci | | In silico prediction (not tested) | | | | Streptococcus porcinus | | In silico prediction (not tested) | | | | Streptococcus pseudopneumoniae | | ATCC BAA-960 | Type strain Canada/2002 | | K193519 - Page 24 of 105 {24} | Organism | | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | *Streptococcus pseudoporcinus* | | *In silico* prediction (not tested) | | **Streptococcus spp. Detected** | | *Streptococcus pyogenes* | | ATCC 49399 | QC A62 | | | *Streptococcus ratti* | | In silico prediction (not tested) | | | | *Streptococcus respiraculi* | | *In silico* prediction (not tested) | | | | *Streptococcus ruminantium* | | *In silico* prediction (not tested) | | | | *Streptococcus salivarius* | - | ATCC 13419 | C699 | | | | *ssp. thermophiles* | ATCC 19258 | Type Strain | | | *Streptococcus sanguinis* | | ATCC 10556 | Type strain | | | *Streptococcus sinensis* | | DSM 14990 | HKU4 Hong Kong | | | *Streptococcus sobrinus*^{a} | | ATCC 33478 | Type strain | | | *Streptococcus suis*^{a} | | ATCC 43765 | Type strain | | | *Streptococcus thoraltensis* | | *In silico* prediction (not tested) | | | | *Streptococcus troglodytae* | | *In silico* prediction (not tested) | | | | *Streptococcus uberisa* | | *In silico* prediction (not tested) | | | | *Streptococcus urinalis* | | *In silico* prediction (not tested) | | | | *Streptococcus vestibularis* | | ATCC 49124 | Type strain United Kingdom | | | *Streptococcus equi* | *ssp. equi* | ATCC 33398 | Type strain | **Streptococcus spp. Detected** (≥7.6E+06 CFU/mL) | | | *ssp. zooepidemicus* | ATCC 43079 | Type strain United Kingdom | | | *Streptococcus entericus* | | *In silico* prediction (not tested) | | | | *Streptococcus halitosis* | | | | | | *Streptococcus hyovaginalis* | | | | | | *Streptococcus pantholopis* | | | | | | **Other *Streptococcus* species** | | No Sequence (not tested) | | **Unknown** | $^{a}$ A small percentage of publicly available sequences for this species have sequence variation under assay primer(s) that may have an impact on detection Table 10: Results for *Streptococcus agalactiae* Isolates Tested | Organism | Serotype^{a} | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | *Streptococcus agalactiae* | II | ATCC 13813 | Type strain | **Streptococcus agalactiae Detected** | | | III | ATCC 12403 | Type strain | | | | V | ATCC BAA-611 | 2603 V/R | | | | VIII | ATCC BAA-2669 | 5030-08 | | | | Unknown | ATCC 12386 | Grouping strain | | | | | NCTC 8017 | MK 104 P | | | | | BF CI-2460 | - | | $^{a}$ Assay reactivity is not serotype-dependent, the assay will react with all serotypes K193519 - Page 25 of 105 {25} Table 11: Results for Streptococcus pneumoniae Isolates Tested | Organism | Serotype\( ^{a} \) | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Streptococcus pneumoniae | 3 | ATCC 6303 | - | Streptococcus pneumoniae Detected | | | 1 | ATCC 33400 | Type strain | | | | 5 | ATCC BAA-341 | SPN1439-106 Columbia/1995 | | | | 14 | ATCC 700672 | VH14/Spain | | | | 11A | NCTC 11900 | Gorman | | | | 19A | ATCC 700673 | 19A-6 Hungary/1989 | | | | Non-capsulated | ATCC BAA-255 | R6 (non-virulent) | | | | unknown | ATCC BAA-1409 | 62076 Canada/2005 | | \( ^{a} \) Assay reactivity is not serotype-dependent, the assay will react with all serotypes Table 12: Results for Streptococcus pyogenes Isolates Tested | Organism | Serotype\( ^{a} \) | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Streptococcus pyogenes | unknown | ATCC 49399 | QC A62 | Streptococcus pyogenes Detected | | | | ATCC 19615 | Bruno | | | | 1 | ATCC 12344 | Type strain | | | | | ATCC 700294 | SF370/M1 GAS | | | | | ATCC BAA-947 | MGAS 5005 Canada/1996 | | | | 3 | ATCC 12384 | C203 | | | | | ATCC BAA-595 | MGAS 315 Texas 1980's | | | | 6 | ATCC 12348 | S43 | | | | Unknown | Clinical Isolate\( ^{b} \) | Missouri/2019 | Not Detected | \( ^{a} \) Assay reactivity is not serotype-dependent, the assay will react with all serotypes \( ^{b} \) Isolate of S. pyogenes with partial gene deletion Table 13: Results for Acinetobacter calcoaceticus-baumannii complex Isolates Tested | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | | Acinetobacter baumannii | CDC FDA AR BANK #0033 | - | Acinetobacter calcoaceticus-baumannii complex Detected | | | ATCC 9955 | 6-561/Italy | | | | ATCC 19606 | Type strain | | | | ATCC 17961 | CDC 7788 | | | | GRE 1153064 | - | | | | GRE 1062081 | - | | | | ATCC 15308 | Biol 1 Maryland/1949 | | | | ATCC 51432 | Pennsylvania | | K193519 - Page 26 of 105 {26} | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | | *Acinetobacter calcoaceticus* | ATCC 23055 | Type strain Netherlands | | | | ATCC 14987 | HO-1/Iowa | | | *Acinetobacter nosocomialis* (formerly genomospecies 13TU) | ATCC 17903 | 2210 Rhode Island/1950 | | | | CCUG 57124 | Sweden/2008 | | | *Acinetobacter pittii* (formerly genomospecies 3) | ATCC 19004 | Type strain United Kingdom/1966 | | | | ATCC 17922 | Pennsylvania | | | *Acinetobacter seifertii* | CCUG 34785 | Type strain Denmark | | | *Acinetobacter nosocomialis* | ATCC 700472^{a} | France/1989 | **Not Detected** | | *Acinetobacter dikshoorniae* | No sequence (not tested) | | **Unknown** | $^{a}$ Sequence data from this isolate suggests that it has been mischaracterized. Sequence data are not consistent with other sequences of *A. nosocomialis* nor with sequences from other species within the *Acinetobacter calcoaceticus-baumannii* complex Table 14: Results for *Bacteroides fragilis* Isolates Tested | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | | *Bacteroides fragilis* | ATCC 25285 | Type strain United Kingdom/1955 | ***Bacteroides fragilis* Detected** | | | ATCC 29771 | 2044 Florida/USA | | | | ATCC 29768 | 12256 | | | | ATCC 43937 | F1355 | | | | ATCC BAA-2283 | 2-1-56 FAA | | K193519 - Page 27 of 105 {27} Table 15: Results for Enterobacterales Isolates Tested and Predicted Reactivity for Species Not Tested | Genus | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Cedeceae | Cedecea davisae | ATCC 43023 | CDC 2819-81 South Carolina | Enterobacterales Detected | | Cedecea neteri | ATCC 33855 | Type strain California | | Citrobacter | Citrobacter amalonaticus | ATCC 25405 | Type strain | | Citrobacter braakii | ATCC 51113 | Type strain France | | Citrobacter farmer | ATCC 51112 | Type strain New York | | Citrobacter freundii | ATCC 8090 | Type strain | | CDC FDA AR Bank #0157 | - | | Citrobacter koseri | ATCC 27156 | CDC 3613-63 | | | ATCC 29223 | CDC 1378/74 | | Citrobacter murliniae | ATCC 51118 | Type strain | | Citrobacter sedlakii | ATCC 51115 | Type strain France | | Citrobacter rodentium | In silico prediction (not tested) | | Citrobacter werkmanii | ATCC 51114 | Type strain Belgium | | Citrobacter youngae | ATCC 29935 | Type strain South Carolina | | Cosenzaea | Cosenzaea (Proteus) myxofaciens | ATCC 19692 | Type strain | | Cronobacter | Cronobacter condimenti | In silico prediction (not tested) | | Cronobacter dublinensis | DSM 18706 | Type strain Switzerland/2004 | | Cronobacter malonaticus | DSM 18702 | Type strain New York | | Crononbacter muytjensii | DSM 51329 | Type strain France | Enterobacterales Detected | | Cronobacter sakazakii | ATCC 29544 | Type strain | | Cronobacter turicensis | CCUG 55852 | Type strain Switzerland 2005 | | Edwardsiella | Edwardsiella anguillarum | In silico prediction (not tested) | | Edwardsiella hoshinae | In silico prediction (not tested) | | Edwardsiella ictaluri | In silico prediction (not tested) | | Edwardseilla piscicida | In silico prediction (not tested) | | Edwardsiella tarda | ATCC 15947 | Type strain Kentucky | | Enterobacter | Enterobacter bugandensis | DSM 29888 | Type strain Tanzania | K193519 - Page 28 of 105 {28} | Genus | Organism | | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | --- | | | Enterobacter cancerogenus | | ATCC 35317 | Type strain New York | | | | Enterobacter roggenkampii | | In silico prediction (not tested) | | | | | Enterobacter soli | | ATCC BAA-2102 | Type strain Peru | | | Escherichia | Escherichia albertii | | CCUG 46494 | Type strain Bangladesh | | | | Escherichia fergusonii | | ATCC 35469 | Type strain Missouri | | | | Escherichia hermanii | | ATCC 33650 | Type strain Louisiana | | | Erwinia | Erwinia billingiae | | In silico prediction (not tested) | | | | Hafnia | Hafnia alvei | | ATCC 51815 | C2 Minnesota | | | | Hafnia paralvei | | ATCC 29927 | Type strain | | | Klebsiella | Klebsiella grimontii | | DSM 105630 | 06D021 | | | | Klebsiella michiganensis | | ATCC BAA-2403 | Type strain Michigan | | | Kluyvera | Kluyvera ascorbate | | CDC FDA AR BANK #0144 | - | | | | Kluyvera cryocrescens | | CCUG 18767T | Type strain | | | | Kluyvera georgiana | | In silico prediction (not tested) | | | | | Kluyvera intermedia | | ATCC 33110 | Type strain | | | Kosakonia | Kosakonia cowanii | | CCUG 62758 | Sweden/2012 | | | | Kosakonia oryzae | | In silico prediction (not tested) | | | | | Kosakonia radicincitans | | In silico prediction (not tested) | | | | Leclercia | Leclercia adecarboxylata | | ATCC 23216 | 1783 | | | Lelliottia | Lelliottia amnigena | | ATCC 51816 | C3 | | | | Leliottia nimipressuralis | | In silico prediction (not tested) | | | | Mixta | Mixta (Pantoea) gaviniae | | CCUG 66381 | - | | | Morganella | Morganella morganii | ssp. morganii | ATCC 25830 | M11 | | | | | | CDC FDA AR BANK #0057 | - | | | | | ssp. sibonii | ATCC 49948 | CDC 8103-85 | | K193519 - Page 29 of 105 {29} | Genus | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Pantoea | Pantoea agglomerans | ATCC 27155 | CDC 1461-67 | Enterobacterales Detected | | | Pantoea ananatis | In silico prediction (not tested) | | | | | Pantoea septica | CCUG 67124 | - | | | Phytobacter | Phytobacter ursingii | In silico prediction (not tested) | | | | Plesiomonas | Plesiomonas shigelloides | ATCC 51572 | CIP 69.35 | | | Pluralibacter | Pluralibacter (Enterobacter) gergoviae | ATCC 33028 | CDC 604-77 | | | Providencia | Providencia alcalifaciens | ATCC 51902 | GNI 3 | | | | Providencia rettgeri | ATCC 9250 | NCTC 1501 | | | | Providencia stuartii | CDC FDA AR Bank #0026 | - | | | Pseudoescherichia | Pseudoescherichia (Escherichia) vulneris | ATCC 33821 | CDC 875-72 | | | Rahnella | Rahnella aquatilis | ATCC 33071 | CUETM 77-115 | | | Raoultella | Raoultella ornithinolytica | ATCC 31898 | AST 111-4 | | | | Raoultella planticola | ATCC 31900 | AST 151-7 | | | | Raoultella terrigenaa | ATCC 33257 | Type strain | | | Serratia | Serratia aquatilis | DSM 100980 | 2015-2462-01 | | | | Serratia entomophilaa | ATCC 43705 | Type strain | | | | Serratia ficaria | In silico prediction (not tested) | | | | | Serratia fonticola | ATCC 29844 | CUETM 77-165 | | | | Serratia grimesii | In silico prediction (not tested) | | | | | Serratia liquefaciens | ATCC 27592 | CDC 1284-57 | | | | Serratia odorifera | ATCC 33077 | 1073 | | | | Serratia plymuthica | ATCC 183 | K-7 | | | | Serratia proteamaculans | In silico prediction (not tested) | | | | | Serratia rubidaea | ATCC 27593 | 2199-72 | | | Sodalis | Sodalis praecaptivus | In silico prediction (not tested) | | | | Shigella | Shigella boydii | ATCC 9207 | AMC 43-G-58 | | | | Shigella dysenteriae | ATCC 13313 | Strain Newcastle | | | | Shigella flexneri | CDC FDA AR Bank #0421 | - | | | | Shigella sonnei | ATCC 29930 | WRAIR I virulent | | | Tatumella | Tatumella ptyseos | ATCC 33301 | H36 | | | Trabulsiella | Trabulsiella guamensis\( ^a \) | ATCC 49490 | Type strain | | | Yersinia | Yersinia aldovae | In silico prediction (not tested) | | | | | Yersinia aleksiciae | In silico prediction (not tested) | | | | | Yersinia enterocolitica | ATCC 9610 | 33114 | | | | Yersinia entomophage | In silico prediction (not tested) | | | | | Yersinia frederiksenii | ATCC 33641 | CDC 1461-81 | | | | Yersinia intermedia | ATCC 33647 | CDC 870-77 | | K193519 - Page 30 of 105 {30} | Genus | Organism | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | | Yersinia kristensenii | ATCC 33639 | CDC 1459-81 | | | | Yersinia massiliensis | In silico prediction (not tested) | | | | | Yersinia mollaretii | ATCC 43969 | CDC 2465-87 | | | | Yersinia pestis | In silico prediction (not tested) | | | | | Yersinia rohdei | In silico prediction (not tested) | | | | | Yersinia ruckeri | In silico prediction (not tested) | | | | | Yersinia similis | In silico prediction (not tested) | | | | Yokenella | Yokenella regensburgei | ATCC 35313 | CDC 3349-72 | Enterobacterales Detected | | Mixta | Mixta (Pantoea) calida | CCUG 68064 - | | Enterobacterales Detected (≥1.1E+07 CFU/mL) | | Yersinia | Yersinia pseudotuberculosis | ATCC 29833 | NCTC 10275 | | | Photorabdus | Photorabdus asymbiotica | ATCC 43950 | 3265-86 | Not Detected | | Arsenophonus | Arsenophonus nasoniae | In silico prediction (not tested) | | | | Providencia | Providencia heimbachae | In silico prediction (not tested) | | | | Other Enterobacterales species | | In silico prediction (not tested) or No sequence (not tested) | | Detected or Unknown | \( ^{a} \) Only tested at high concentration (>1.0E+09 CFU/mL), expected to be detected at positive blood culture levels and lower Table 16: Results for Enterobacter cloacae complex Isolates Tested | Organism | | Source ID | Strain/Location/Year | Result | | --- | --- | --- | --- | --- | | Enterobacter asburiae | | GRE 1753006 | - | Enterobacter cloacae complex Detected | | Enterobacter cloacae | - | CDC FDA AR Bank #0154 | - | | | | | CDC FDA AR Bank #0501 | - | | | | | ATCC 49141 | AmMS 204 | | | | | ATCC BAA-2341 | 1101152 | | | | | NCTC 13464 | - | | | | ssp. cloacae | ATCC 13047 | Type strain | | | | | ATCC BAA-1143 | Entb 55M | | | | spp. dissolvens | ATCC 23373D | Type strain | | | Enterobacter hormaechei | - | ATCC BAA-2082 | - | | | | ssp. oharae | CCUG 53905T | Type strain Germany | | | | ssp. steigerwalthii | CCUG 53904T | Type strain Belgium | | | | ssp. xiangfangensis | DSM 46348 | 1080M | | | Enterobacter kobei | | GRE 1753004 | - | | | Enterobacter ludwigii | | CCUG 23050 | Sweden | | | Enterobacter mori | | DSM 26271 | Type strain/R18-2 | | K193519 - Page 31 of 105 {31} | Organism | | Source ID | Strain/Location/Year |…