cobas MRSA/SA Test
Device Facts
| Record ID | K142721 |
|---|---|
| Device Name | cobas MRSA/SA Test |
| Applicant | Roche Molecular Systems, Inc. |
| Product Code | NQX · Microbiology |
| Decision Date | Dec 17, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
Intended Use
The cobas® MRSA/SA Test on the cobas® 4800 system, is a qualitative in vitro diagnostic real-time PCR assay, for the direct detection of methicillin-resistant Staphylococus aureus (MRSA) and S.aureus (SA) DNA from nasal swabs to aid in the prevention and control of MRSA and SA infections in healthcare settings. The cobas® MRSA/SA Test is not intended to diagnose, guide or monitor treatment for MRSA or SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiology typing or for further susceptibility testing.
Device Story
The cobas® MRSA/SA Test is a qualitative in vitro diagnostic assay performed on the cobas® 4800 System. It processes nasal swab specimens collected in MSwab medium. The system uses the cobas x 480 instrument for automated nucleic acid extraction via magnetic glass particles and the cobas z 480 analyzer for real-time PCR amplification and detection. The assay targets the SCCmec/orfX junction for MRSA and the capsular polysaccharide enzyme (cpe) gene for S. aureus. An internal control is used to monitor the process. The system software interprets fluorescent signals from TaqMan probes to report results. It is intended for use in healthcare settings to aid in infection control by identifying nasal colonization. Results are provided to healthcare providers to inform infection control measures; however, the test does not provide susceptibility data, and concomitant cultures are required for further typing.
Clinical Evidence
Prospective, multi-site clinical investigation (n=2504 evaluable subjects). Compared cobas MRSA/SA Test to combined direct and enrichment culture. MRSA sensitivity 93.1%, specificity 97.5%. SA sensitivity 93.9%, specificity 94.2%. Reproducibility established across sites, operators, and reagent lots with CV% ≤ 1.4%.
Technological Characteristics
Real-time PCR assay. Targets: orfX/SCCmec junction (MRSA) and CAP5N gene (SA). Automated extraction via cobas x 480 instrument using magnetic glass particles. Detection via TaqMan fluorescent probes. System includes cobas x 480 (extraction) and cobas z 480 (amplification/detection) analyzers. Software-controlled.
Indications for Use
Indicated for direct detection of MRSA and S. aureus DNA from nasal swabs in patients to aid in the prevention and control of MRSA and SA infections in healthcare settings. Not for diagnosing, guiding, or monitoring treatment of infections, or determining methicillin susceptibility.
Regulatory Classification
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Predicate Devices
- Roche Lightcycler MRSA (k091409)
Related Devices
- K132468 — MRSA/SA ELITE MGB, ELITE MGB SOFTWARE · Elitechgroup Epoch Biosciences · Oct 17, 2013
- K112937 — MRSA/SA ELITE MGB · Elitech · Jun 1, 2012
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE MOLECULAR SYSTEMS, INC. WILK VON GUSTEDT, PH.D. SR. REGULATORY SPECIALIST II 4300 HACIENDA DRIVE PLEASANTON CA 94588-2722
December 17, 2014
Re: K142721
Trade/Device Name: cobas MRSA/SA Test Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: NOX, OOI Dated: September 22, 2014 Received: September 23, 2014
Dear Dr. von Gustedt:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Uwe Scherf -S for
Sally A. Hojvat. 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) k142721
Device Name cobas® MRSA/SA Test
### Indications for Use (Describe)
The cobas® MRSA/SA Test on the cobas® 4800 system, is a qualitative in vitro diagnostic real-time PCR assay, for the direct detection of methicillin-resistant Staphylococus aureus (MRSA) and S.aureus (SA) DNA from nasal swabs to aid in the prevention and control of MRSA and SA infections in healthcare settings. The cobas® MRSA/SA Test is not intended to diagnose, guide or monitor treatment for MRSA or SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiology typing or for further susceptibility testing.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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# 510(k) Summary
| Submitter Name | Roche Molecular Systems, Inc. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 4300 Hacienda Drive<br>Pleasanton, CA 94588-2722 |
| Contact | Wilk von Gustedt<br>Phone: (925) 730-8046<br>FAX: (925) 225-0207 |
| Date Prepared | September 18, 2014 |
| Proprietary Name | cobas® MRSA/SA Test |
| Common Name | MRSA/SA Test |
| Classification Name | Antimicrobial susceptibility test powder. (21 CFR 866.1640)<br>Real Time Nucleic Acid Amplification System (21 CFR 862.2570) |
| Product Codes | NQX: System, Nucleic Acid amplification Test, DNA, Methicillin Resistant<br>Staphylococcus aureus, Direct Specimen<br>OOI: Real Time Nucleic Acid Amplification System |
| Predicate Devices | Roche Lightcycler MRSA, k091409 |
| Establishment Registration | Branchburg: 2243471<br>Pleasanton: 3004141078<br>Indianapolis: 1823260 |
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#### 1. DEVICE DESCRIPTION
The Roche Molecular Systems (RMS) cobas® MRSA/SA Test utilizes real-time polymerase chain reaction (PCR) for the detection of Methicillin resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA from nasal swab specimens collected in MSwab medium to aid in the prevention and control of MRSA and SA infections in healthcare settings.
The cobas® MRSA/SA Test contains two major processes: (1) automated sample preparation to extract nucleic acids from the nasal swab specimens; (2) PCR amplification of target DNA sequences using MRSA and SA specific primers, and real-time detection of cleaved fluorescentlabeled MRSA and SA specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process.
The MSwab Collection, Transport and Preservation System (Copan Flock Technologies S.r.1.) is used for specimen collection, transportation and storage of specimen for the cobas MRSA/SA Test.
The cobas® MRSA/SA Test utilizes six reagent kits:
- 1. cobas® 4800 MRSA/SA Amplification/Detection Kit
- 2. cobas® 4800 MRSA/SA Controls and Cofactor Kit
- 3. cobas® 4800 System Wash Buffer Kit
- 4. cobas® 4800 System Lysis Kit 1
- 5. cobas 4800 System Internal Control Kit 1
- 6. cobas® 4800 System Sample Preparation Kit
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#### 1.1. Target Selection
The well-characterized Right Extremity (RE) junction between the Staphylococcus aureus orfX gene and SCCmec cassette carrying the mecA drug-resistant gene was chosen to be the target to specifically detect MRSA. The capsular polysaccharide enzyme CAP5N (CPE) gene was chosen as the target for Staphylococcus aureus identification. This gene is conserved in Staphylococcus aureus and present in both methicillin resistant and methicillin sensitive organisms. Internal Control (IC) DNA sequence is unique and unrelated to either MRSA or SA target sequences.
#### Test Principle 1.2.
#### Sample Preparation 1.1.1.
Sample preparation for the cobas® MRSA/SA Test is automated with the use of the cobas x 480 instrument. Organisms in nasal swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. They are washed and then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix.
# 1.1.2. PCR Amplification and TaqMan® Detection
The PCR cycling steps and detection of target signal occurs in the cobas z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for orfX (MRSA), CPE (SA) and IC targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher suppresses the fluorescence of the dye. However, if the PCR product is present, the probe hybridizes to the product and gets cleaved by the 5' to 3' nuclease activity of the polymerase. This reaction allows the fluorescence to be emitted from the dye, and the signal is recorded in real time during each PCR cycle by the cobas z 480 analyzer. The signal is interpreted by the cobas 4800 System Software and reported as final results.
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#### cobas® 4800 System Description 1.3.
The cobas® 4800 System uses the cobas x 480 Instrument for sample preparation, and the cobas z 480 Analyzer for amplification and detection. Both the cobas x 480 Instrument and the cobas z 480 Analyzer are controlled by a computer workstation running the cobas® 4800 System Software.
The system hardware is unchanged from that originally approved for IVD use in PMA P100020 (cobas® HPV Test, April 19, 2011). The software version has been updated to software release 2.1 in order to support the expanded test menu. The updated software was cleared for other currently available tests on the cobas® 4800 System per Special 510(K) 140887.
#### INDICATIONS FOR USE 2.
The cobas® MRSA/SA Test on the cobas® 4800 system, is a qualitative in vitro diagnostic realtime PCR assay, for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) and S.aureus (SA) DNA from nasal swabs to aid in the prevention and control of MRSA and SA infections in healthcare settings. The cobas® MRSA/SA Test is not intended to diagnose, guide or monitor treatment for MRSA or SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiology typing or for further susceptibility testing.
#### TECHNOLOGICAL CHARACTERISTICS 3.
As indicated in Table 1, the RMS cobas® MRSA/SA Test has the same general intended use as the predicate device. The subject device is substantially equivalent from its technological characteristics to the currently legally marketed predicate device.
Differences reside in sample collection and preparation. The candidate test utilizes an automated extraction process while the predicate uses a manual process. However both devices are similar in the method used for extraction of nucleic acids from specimens, using glass beads together with Lysis buffer. The additional (SA) target detected by the cobas® MRSA/SA test uses the same technological methodology as used for detection of the MRSA target.
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| | Submitted Device:<br>RMS cobas® MRSA/SA Test | Predicate Device:<br>Lightcycler® MRSA Advanced Test<br>K091409 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cobas® MRSA/SA Test on the<br>cobas® 4800 system, is a qualitative <i>in</i><br><i>vitro</i> diagnostic real-time PCR assay, for<br>the direct detection of methicillin-resistant<br><i>Staphylococcus aureus</i> (MRSA) and<br><i>S.aureus</i> (SA) DNA from nasal swabs to<br>aid in the prevention and control of MRSA<br>and SA infections in healthcare settings.<br>The cobas® MRSA/SA Test is not<br>intended to diagnose, guide or monitor<br>treatment for MRSA or SA infections, or<br>provide results of susceptibility to<br>methicillin. A negative result does not<br>preclude MRSA/SA nasal colonization.<br>Concomitant cultures are necessary to<br>recover organisms for epidemiology typing<br>or for further susceptibility testing. | The LightCycler® MRSA Advanced Test is<br>a qualitative <i>in vitro</i> diagnostic test for the<br>direct detection of nasal colonization with<br>methicillin-resistant (MRSA) to aid in the<br>prevention and control of MRSA infections<br>in healthcare settings. The test is<br>performed on the LightCycler® 2.0<br>Instrument with nasal swab specimens<br>from patients suspected of colonization,<br>uses swab extraction and mechanical lysis<br>for specimen preparation followed by<br>polymerase chain reaction (PCR) for the<br>amplification of MRSA DNA, and<br>fluorogenic target specific hybridization<br>probes for the detection of the amplified<br>DNA.<br>The LightCycler® MRSA Advanced Test is<br>not intended to diagnose, guide or monitor<br>treatment for MRSA infections.<br>Concomitant cultures are necessary to<br>recover organisms for epidemiology typing<br>or for further susceptibility testing. |
| Conditions for use | For prescription use | Same |
| Sample Types | Nasal swab | Same |
| Amplification Technology | Real-time PCR | Same |
| Detection Chemistry | paired target-specific hybridization probes<br>using Förster resonance energy transfer<br>(FRET) | Same |
| Controls used | Sample processing control (IC)<br>Positive and negative control | Same |
| Analyte Target | SCCmec cassette Right Extremity (RE)<br>junction of methicillin-resistant<br><i>Staphylococcus aureus</i> (MRSA) | Same target region for MRSA detection |
### Similarities and Differences between the cobas® MRSA/SA Test Table 1: and the Predicate Device
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| | Submitted Device:<br>RMS cobas® MRSA/SA Test | Predicate Device:<br>Lightcycler® MRSA Advanced Test<br>K091409 | | | |
|---------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Differences | | | | | |
| Sample Collection Devices | Copan MSwab Collection, Transport<br>and Preservation System | Liquid Stuart Swabs, Amies Gel with<br>Charcoal Swabs, Amies Gel without<br>Charcoal Swabs | | | |
| Analyte Target | wt Staphylococcus aureus (SA) | methicillin-resistant Staphylococcus<br>aureus (MRSA) only | | | |
| Sample Preparation<br>Procedure | Automated by cobas® x480 | Lysis of the nasal swab specimens is<br>performed by using the LightCycler®<br>Advanced Lysis Kit and the MagNA Lyser<br>Instrument. | | | |
| Result Analysis | Based on PCR cycle threshold analysis | Melting peak analysis | | | |
In summary, the intended use and technological characteristics of the cobas® MRSA/SA Test as compared to the predicate device do not raise any new types of safety or effectiveness questions and are substantially equivalent.
#### 4. NON-CLINICAL PERFORMANCE EVALUATION
#### Analytical Sensitivity 4.1.
The analytical sensitivity (Limit of Detection or LOD) for the cobas® MRSA/SA Test was determined by analyzing 2 MRSA culture isolates and 1 SA culture isolate. Quantified cultures were diluted to 8-9 concentration levels into a simulated nasal swab background matrix to determine the LOD. All levels were analyzed using cobas® MRSA/SA Test with 3 unique lots of MRSA/SA specific reagents. The LOD of the test was determined as the lowest concentration exhibiting at least 95% positive rate for which all higher concentrations were greater than or equal to 95% positive rate.
The highest LOD among 3 reagent lots are shown in Table 2. The highest claimed LOD between the 2 MRSA strains tested was 700 CFU/swab and for SA it was 700 CFU/swab based on 95% positive rate.
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| Isolate Name | Source ID | RE type | SCCmec<br>type | spa type | PFGE<br>type | MIC<br>value | LOD<br>(CFU/swab) |
|--------------|------------|---------|----------------|----------|--------------|--------------|-------------------|
| MRSA 10364 | NARSA 384 | 2 | IVa | t008 | USA300-0114 | 32 | 650 |
| MRSA 8065 | ATCC 43300 | 2 | II | t007 | Sac-15 | n/a | 700 |
| SA 10851 | NARSA 164 | n/a | n/a | t084 | n/a | n/a | 700 |
cobas® MRSA/SA Test Limit of Detection Table 2:
#### Genotype LOD verification 4.2.
The sensitivity of the cobas MRSA/SA Test was determined for 35 additional MRSA culture isolates and 5 additional SA culture isolates. The genotype LOD panel consisted of at least three concentrations per isolate in simulated nasal swab background matrix. The LOD was calculated as the lowest concentration level with ≥ 95 % positive rate for which all higher concentration levels show ≥ 95 % positive rate. A minimum of one lot of reagents was used for this study.
The genotype LOD study results are listed in Table 4. As shown in Table 3, the LOD is ranging from 175 to 750 CFU/swab for the 35 MRSA isolates tested. The cobas MRSA/SA Test detected the RE types 1, 2, 3, 4, 6, 9, 11, 14, 24 and 25. The cobas MRSA/SA Test detected MRSA SCCmec types I, II, III, IV, V, VI and VIII, as well as MRSA PFGE types USA 100 to 1000. Five SA isolates tested represent 5 different spa types, and the LOD is 175 CFU/swab for all isolates (Table 4).
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| Isolate # | RE Type | SCCmec Type | spa Type | Cefoxitin MIC Value*<br>(μg/mL) | PFGE Type | LOD (CFU/Swab) |
|-----------|---------|-------------|----------|---------------------------------|-----------|----------------|
| 1 | 11 | new | t002 | ≥8 | Unknown | 485 |
| 2 | 6 | II | t242 | ≥8 | Unknown | 720 |
| 3 | 9/11 | new | t024 | ≥8 | Unknown | 175 |
| 4 | 14 | Unknown | Unknown | Unknown | Unknown | 700 |
| 5 | 25 | Unknown | t003 | ≥8 | Unknown | 175 |
| 6 | 6 | II | t216 | ≥8 | USA100 | 720 |
| 7 | 2 | IV | t008 | ≥8 | USA300 | 350 |
| 8 | 2 | II | t037 | ≥8 | USA200 | 700 |
| 9 | 2 | IV | t1578 | ≥8 | USA300 | 700 |
| 10 | 2 | II | t002 | ≥8 | USA100 | 720 |
| 11 | 2 | IV | t008 | ≥8 | USA800 | 750 |
| 12 | 2 | IV | t008 | ≥8 | USA300 | 266 |
| 13 | 2 | IV | t064 | ≥8 | USA500 | 260 |
| 14 | 2 | IV | t148 | ≥8 | USA700 | 700 |
| 15 | 2 | IV | t688 | ≥8 | USA800 | 271 |
| 16 | 2 | IV | t688 | ≥8 | USA300 | 700 |
| 17 | 2 | II | t042 | ≥8 | USA100 | 463 |
| 18 | 2 | II | t018 | ≥8 | USA200 | 350 |
| 19 | 2 | IV | t008 | ≥8 | USA300 | 410 |
| 20 | 2 | IV | t008 | ≥8 | USA300 | 175 |
| 21 | 2 | IV | t5576 | ≥8 | USA800 | 202 |
| 22 | 2 | II | t004 | ≥8 | USA600 | 350 |
| 23 | 2 | IV | t216 | ≥8 | USA1000 | 350 |
| 24 | 2 | IV | t064 | ≥8 | Iberian | 175 |
| 25 | 2 | II | t266 | ≥8 | USA600 | 700 |
| 26 | 2 | IV | t008 | ≥8 | USA300 | 700 |
| 27 | 2 | IV | t008 | ≥8 | USA300 | 350 |
| 28 | 2 | IV | t002 | ≥8 | USA800 | 350 |
| 29 | 3 | V | t242 | ≥8 | USA1000 | 350 |
| 30 | 24 | new | t476 | ≥8 | Unknown | 350 |
| 31 | 1 | I | t149 | ≥8 | Unknown | 175 |
| 32 | 3 | VIII | Unknown | ≥8 | Unknown | 700 |
| 33 | 4 | IV | Unknown | ≥8 | Unknown | 350 |
| 34 | 2 | III | t030 | ≥8 | Unknown | 700 |
| 35 | 25 | VI | Unknown | Unknown | Unknown | 175 |
Table 3: MRSA isolate LOD Results
*Isolates 1,2,5-10, 12-29, 31 and 34 have Cefoxitin MC values 3,11 and 32 have Cefoxitin
MC values of ≥16 µg/mL; isolate 33 has an Cefoxitin MC value of 12 µg/mL; isolate value of 8 µg/mL.
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| SA Isolate # | spa Type | LOD (CFU/Swab) |
|--------------|----------|----------------|
| 1 | t238 | 175 |
| 2 | t018 | 175 |
| 3 | t008 | 175 |
| 4 | t002 | 175 |
| 5 | t088 | 175 |
Table 4: SA Isolates LOD Results
#### 4.3. Geographical Inclusivity
In addition to 37 MRSA isolates and 6 SA isolates tested in analytical LOD and genotype LOD studies shown above, the inclusivity was also examined by testing a broad collection of MRSA and SA isolates from diverse geographical locations. Two hundred and eighty-one (281) MRSA from 16 European countries or regions, US, Japan and Australia and 85 SA isolates from diverse locations within US were tested. The MRSA collection contained MRSA isolates of different SCCmec types (I, II, III, IV, IVa, V, VI, VII, and new), and 71 spa types and cefoxitin MIC value from 6 to greater than 256. All 85 SA isolates sourced from the US contains 75 spa types were detected by the cobas® MRSA/SA Test. The geographical inclusivity study results for MRSA isolates are listed in Table 5. Of the two hundred eighty-one MRSA isolates, two hundred seventy-seven of the MRSA isolates were detected. The four MRSA isolates not detected by the cobas® MRSA/SA Test were sequenced, and the results suggested that the target regions contained sequences not recognized by the primers and probes in the cobas MRSA/SA Test. One of the four isolates was a mec ALGA251 (also known as mec C) strain.
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| Geographical Origin | Total Number of MRSA Isolates | Detected by cobas® MRSA/SA Test |
|---------------------|-------------------------------|---------------------------------|
| England | 58 | 58 |
| Germany | 51 | 51 |
| Denmark | 37 | 36 |
| France | 33 | 31 |
| US | 20 | 20 |
| Spain | 20 | 20 |
| Switzerland | 18 | 18 |
| Japan | 15 | 15 |
| Sweden | 7 | 7 |
| Australia | 6 | 5 |
| Netherlands | 5 | 5 |
| Italy | 4 | 4 |
| Belgium | 3 | 3 |
| Scotland | 2 | 2 |
| Ireland | 1 | 1 |
| Norway | 1 | 1 |
| Total | 281 | 277 |
Geographical Coverage of the cobas® MRSA/SA Test for MRSA Isolates Table 5:
#### 4.4. Precision
In-house precision study was conducted with 2 MRSA culture isolates and 1 SA culture isolate a concentrations below, near and above Limit of Detection (LOD) of the cobas® MRSA/SA Test. The study used three unique lots of cobas® MRSA/SA Test reagents and three instruments for a total of 36 runs over 12 days (3 runs per day). A description of the precision panels, the study results, and variance components are shown in Table 6. An analysis of the variance of the Ct values from valid tests was performed on positive panel members above LOD concentrations. Overall, most of the variation in the cobas® MRSA/SA Test was attributed to random factors (41.2% - 44.9%) with contribution from reagent lot, kit size and run/day of testing (Table 7). The overall CV% of Ct values for cobas® MRSA/SA Test was less than or equal to 1.3% indicating good reproducibility (Table 8).
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| Target | Target<br>Concentration | Result interpretation | | | Total<br>Sample<br>Tested | %Detect<br>ed | 2-sided<br>95% Lower<br>CL | 2-sided<br>95% Upper<br>CL |
|----------------------------------------------------|-------------------------|-----------------------|----|----|---------------------------|---------------|----------------------------|----------------------------|
| Negative | No analyte | 72 | 0 | 0 | 72 | 0.0% | 0.0% | 5.0% |
| MRSA<br>Culture<br>Isolate 10364<br>(NARSA 384) | < 1.0 x LOD | 0 | 15 | 57 | 72 | 79.2% | 68.0% | 87.8% |
| MRSA<br>Culture<br>Isolate 10364<br>(NARSA 384) | ~ 1.0 x LOD | 0 | 0 | 72 | 72 | 100.0% | 95.0% | 100.0% |
| MRSA<br>Culture<br>Isolate 10364<br>(NARSA 384) | ~ 3.0 x LOD | 0 | 0 | 72 | 72 | 100.0% | 95.0% | 100.0% |
| MRSA<br>Culture<br>Isolate 8065<br>(ATCC<br>43300) | < 1.0 x LOD | 0 | 9 | 63 | 72 | 87.5% | 77.6% | 94.1% |
| MRSA<br>Culture<br>Isolate 8065<br>(ATCC<br>43300) | ~ 1.0 x LOD | 0 | 0 | 72 | 72 | 100.0% | 95.0% | 100.0% |
| MRSA<br>Culture<br>Isolate 8065<br>(ATCC<br>43300) | ~ 3.0 x LOD | 0 | 0 | 72 | 72 | 100.0% | 95.0% | 100.0% |
| SA Culture<br>Isolate 10851<br>(NARSA 164) | < 1.0 x LOD | 4 | 67 | 0 | 71* | 94.4% | 86.2% | 98.4% |
| SA Culture<br>Isolate 10851<br>(NARSA 164) | ~ 1.0 x LOD | 0 | 72 | 0 | 72 | 100.0% | 95.0% | 100.0% |
| SA Culture<br>Isolate 10851<br>(NARSA 164) | ~ 3.0 x LOD | 0 | 72 | 0 | 72 | 100.0% | 95.0% | 100.0% |
Table 6: In-House Precision Study Positive Rate Analysis
*One of 72 samples tested could not be processed due to sample pipetting error on the instrument.
| Table 7: Variance Components Analysis of MRSA and SA Ct for cobas MRSA/SA Test |
|--------------------------------------------------------------------------------|
| |
| | | | Variance Components/Percent Contribution to Total | | | | | | |
|----------------------------------------------|----|------------|---------------------------------------------------|----------|------------|---------|--------|--------|--|
| Target | N | Mean<br>Ct | Lot | Kit Size | Instrument | Run/Day | Random | Total | |
| MRSA Culture<br>Isolate 10364<br>(NARSA 384) | 72 | 36.9 | 0.057 | 0.003 | 0.027 | 0.057 | 0.101 | 0.244 | |
| | | | 23.2% | 1.2% | 11.1% | 23.3% | 41.2% | 100.0% | |
| MRSA Culture<br>Isolate 8065<br>(ATCC 43300) | 72 | 38.0 | 0.003 | 0.024 | 0.007 | 0.010 | 0.037 | 0.082 | |
| | | | 4.1% | 29.6% | 8.9% | 12.5% | 44.9% | 100.0% | |
| SA Culture<br>Isolate 10851<br>(NARSA 164) | 72 | 35.6 | 0.050 | 0.023 | 0.007 | 0.032 | 0.082 | 0.193 | |
| | | | 25.9% | 11.7% | 3.6% | 16.5% | 42.3% | 100.0% | |
{15}------------------------------------------------
| Target | N | Mean Ct | Standard Deviation Components/CV Percent | | | | | |
|----------------------------------------------|----|---------|------------------------------------------|----------|------------|---------|--------|-------|
| | | | Lot | Kit Size | Instrument | Run/Day | Random | Total |
| MRSA Culture<br>Isolate 10364<br>(NARSA 384) | 72 | 36.9 | 0.238 | 0.054 | 0.165 | 0.239 | 0.317 | 0.494 |
| | | | 0.6% | 0.1% | 0.4% | 0.6% | 0.9% | 1.3% |
| MRSA Culture<br>Isolate 8065<br>(ATCC 43300) | 72 | 38.0 | 0.058 | 0.156 | 0.086 | 0.102 | 0.192 | 0.287 |
| | | | 0.2% | 0.4% | 0.2% | 0.3% | 0.5% | 0.8% |
| SA Culture<br>Isolate 10851<br>(NARSA 164) | 72 | 35.6 | 0.224 | 0.150 | 0.084 | 0.178 | 0.286 | 0.440 |
| | | | 0.6% | 0.4% | 0.2% | 0.5% | 0.8% | 1.2% |
Standard Deviation Components/CV Percent for cobas® MRSA/SA Test Table 8:
#### Analytical Specificity 4.5.
Analytical specificity of the cobas® MRSA/SA Test was examined by testing non-MRSA/SA microorganisms commonly present in nasal flora, including coagulase negative and positive Staphylococcus species, as well as human cells in the presence or absence of MRSA and SA targets. For the MRSA target, SA organisms including BORSA strains and "empty cassette variants" (also known as "mec A drop outs") were also tested at high concentration to examine any cross-reactivity and/or interference with MRSA detection.
Table 9 shows the result for Coagulase-Negative Staphylococcus (CoNS) and Methicillin-Resistant Coagulase-Negative Staphylococcus (MR-CoNS) Organisms. Table 10 summarizes results of microorganisms commonly found in nasal flora including human cell line HCT-15.
All target negative samples generated negative MRSA and SA results, demonstrating that the cobas® MRSA/SA Test does not cross-react with these microorganisms and human DNA. None of the 135 organisms and the human cells interfered with the detection of both MRSA and SA targets by the cobas® MRSA/SA Test.
Table 11 presents the analytical specificity results in presence of 2 SA isolates, 10 BORSA isolates and 16 mecA dropouts.
The cobas® MRSA/SA Test did not generate false negative and false positive results for MRSA in the presence of 2 SA isolates, 10 BORSA, and 13 of 16 mecA dropouts.
{16}------------------------------------------------
| | Organisms | Strain/ATCC ID | No target | | MRSA 10364<br>(NARSA 384) | | MRSA 8065<br>(ATCC 43300) | | SA 10851<br>(NARSA 164) | |
|----|--------------------------------------------------------------------------------------|--------------------|-----------|-----|---------------------------|-----|---------------------------|-----|-------------------------|-----|
| | | | MRSA | SA | MRSA | SA | MRSA | SA | MRSA | SA |
| 1 | Staphylococcus arlettae | ATCC43957 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 2 | Staphylococcus auricularis<br>(Methicillin-resistant) | ATCC33753 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 3 | Staphylococcus caprae<br>(Methicillin-resistant) | ATCC35538 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 4 | Staphylococcus captis | ATCC35661 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 5 | Staphylococcus carnosus | ATCC51365 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 6 | Staphylococcus chromogenes | ATCC43764 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 7 | Staphylococcus cohnii | ATCC35662 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 8 | Staphylococcus delphini | MayoClinicH18859** | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 9 | Staphylococcus epidermidis<br>(Methicillin-resistant) | ATCC14990 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 10 | Staphylococcus epidermidis<br>(Methicillin-resistant) | ATCC35547 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 11 | Staphylococcus epidermidis<br>(Methicillin-resistant) | ATCC35983 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 12 | Staphylococcus epidermidis<br>(Methicillin-resistant) | ATCC35984 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 13 | Staphylococcus epidermidis<br>(Methicillin-resistant) | ATCC51624 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| | Organisms | Strain/ATCC ID | No target | | MRSA 10364<br>(NARSA 384) | | MRSA 8065<br>(ATCC 43300) | | SA 10851<br>(NARSA 164) | |
| | | | MRSA | SA | MRSA | SA | MRSA | SA | MRSA | SA |
| 14 | Staphylococcus epidermidis<br>(Methicillin-resistant) | ATCC51625 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 15 | Staphylococcus epidermidis | ATCC700583 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 16 | Staphylococcus epidermidis<br>(Methicillin-resistant) | ATCC27676 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 17 | Staphylococcus equorum | ATCC43958 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 18 | Staphylococcus felis | ATCC49168 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 19 | Staphylococcus gallinarum | ATCC35539 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 20 | Staphylococcus haemolyticus<br>(Methicillin-resistant) | ATCC29968 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 21 | Staphylococcus haemolyticus | ATCC29970 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 22 | Staphylococcus haemolyticus | ATCC43252 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 23 | Staphylococcus hominis | ATCC25615 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 24 | Staphylococcus hominis | ATCC35982 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 25 | Staphylococcus hominis subsp. Hominis | ATCC27844 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 26 | Staphylococcus hominis subsp. Hominis | ATCC27845 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 27 | Staphylococcus intermedius | ATCC29663 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 28 | Staphylococcus kloosii | ATCC43959 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 29 | Staphylococcus lentus | ATCC29070 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 30 | Staphylococcus lugdunensis | ATCC49576 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 31 | Staphylococcus pasteuri | ATCC51129 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 32 | Staphylococcus pseudointermedius | DSMZ21284** | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 33 | Staphylococcus pulvereri | ATCC51698 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| | Organisms | Strain/ATCC ID | No target | | MRSA 10364<br>(NARSA 384) | | MRSA 8065<br>(ATCC 43300) | | SA 10851<br>(NARSA 164) | |
| | | | MRSA | SA | MRSA | SA | MRSA | SA | MRSA | SA |
| 34 | Staphylococcus saprophyticus | ATCC15305 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 35 | Staphylococcus schleiferi<br>(subspecies coagulans) | ATCC43808 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 36 | Staphylococcus sciuri | ATCC49575 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 37 | Staphylococcus simulans<br>(Methicillin-resistant) | ATCC27848 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 38 | Staphylococcus simulans | ATCC11631 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 39 | Staphylococcus warneri | ATCC27836 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 40 | Staphylococcus warneri<br>(Methicillin-resistant) | ATCC27839 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 41 | Staphylococcus warneri | RMSCC 1224** | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 42 | Staphylococcus xylosus | ATCC35663 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 43 | Staphylococcus xylosus | ATCC29971 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| | Organisms | Strain/ATCC ID | No target | | MRSA 10364<br>(NARSA 384) | | MRSA 8065<br>(ATCC 43300) | | SA 10851<br>(NARSA 164) | |
| | | | MRSA | SA | MRSA | SA | MRSA | SA | MRSA | SA |
| 1 | Acinetobacter baumannii | ATCC19606 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 2 | Acinetobacter haemolyticus | ATCC17906 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 3 | Bacillus cereus | ATCC13472 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 4 | Bordetella bronchioseptica | ATCC19395 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 5 | Bordetella parapertussis | ATCC15311 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 6 | Bordetella pertussis | ATCC9797 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 7 | Burkholderia cepacia | ATCC25416 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 8 | Candida albicans | ATCC10231 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 9 | Candida glabrata | ATCC2001 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 10 | Candida parapsilosis | ATCC22019 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 11 | Candida tropicalis | ATCC750 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 12 | Chlamydia pneumoniae | CDC-CWL-011 strain | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 13 | Citrobacter freundii | ATCC8090 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 14 | Citrobacter koseri | ATCC27028 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 15 | Corynebacterium amycolatum | ATCC49368 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 16 | Corynebacterium bovis | ATCC7715 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 17 | Corynebacterium flavescens | ATCC10340 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 18 | Corynebacterium genitalium | ATCC33030 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 19 | Corynebacterium glutamicum | ATCC13032 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 20 | Corynebacterium jeikeium | ATCC43734 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 21 | Cryptococcus neoformans | ATCC32719 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| | Organisms | Strain/ATCC ID | No target | | MRSA 10364<br>(NARSA 384) | | MRSA 8065<br>(ATCC 43300) | | SA 10851<br>(NARSA 164) | |
| | | | MRSA | SA | MRSA | SA | MRSA | SA | MRSA | SA |
| 22 | Eikenella corrodens | ATCC23834 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 23 | Enterobacter aerogenes | ATCC13048 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 24 | Enterobacter cloacae | ATCC13047 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 25 | Enterococcus flavescens | ATCC49996 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 26 | Enterococcus gallinarum | ATCC49573 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 27 | Enterococcus hirae | ATCC8043 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 28 | Escherichia coli | ATCC11775 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 29 | Finegoldia magna | RMSCC 974** | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 30 | Haemophilus aphrophilus | ATCC19415 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 31 | Haemophilus influenzae | ATCC33391 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 32 | Haemophilus parainfluenzae | ATCC33392 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 33 | Issatchenkia orientalis | ATCC6258 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 34 | Klebsiella oxytoca | ATCC33496 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 35 | Klebsiella pneumoniae (KPC<br>producing) | ATCC700603 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 36 | Klebsiella pneumoniae (KPC<br>producing) | ATCC BAA1900 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 37 | Lactobacillus crispatus | ATCC33820 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 38 | Lactobacillus delbrueckii | ATCC12315 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 39 | Legionella pneumophila | ATCC33152 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 40 | Leifsonia aquatica (formerly known as<br>Corynebacterium aquaticum) | ATCC14665 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 41 | Listeria monocytogenes | ATCC15313 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 42 | Microbacterium testaceum | ATCC15829 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| | Organisms | Strain/ATCC ID | No target | | MRSA 10364<br>(NARSA 384) | | MRSA 8065<br>(ATCC 43300) | | SA 10851<br>(NARSA 164) | |
| | | | MRSA | SA | MRSA | SA | MRSA | SA | MRSA | SA |
| 43 | Micrococcus luteus | ATCC4698 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 44 | Moraxella catarrhalis | ATCC8176 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 45 | Mycobacterium tuberculosis avirulent | ATCC25177 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 46 | Mycoplasma pneumoniae | ATCC15531 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 47 | Mycoplasma salivarium | ATCC23064 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 48 | Neisseria meningitidis | ATCC13077 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 49 | Parvimonas micra | ATCC33270 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 50 | Pasteurella aerogenes | ATCC27883 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 51 | Planococcus maritimus | RMSCC11454** | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 52 | Proteus mirabilis | ATCC29906 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 53 | Proteus vulgaris | RMSCC204** | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 54 | Providencia stuartii | ATCC22914 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 55 | Pseudomonas aeruginosa | ATCC33584 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 56 | Pseudomonas fluorescens | ATCC11250 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 57 | Rhodococcus equi | ATCC6939 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 58 | Rothia mucilaginosa | ATCC25296 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 59 | Salmonella enterica subsp. Enterica<br>(formerly known as Salmonella<br>typhimurium) | RMSCC374* | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 60 | Serratia marcescens | ATCC8100 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 61 | Shigella sonnei | ATCC29930 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 62 | Streptococcus agalactiae | RMSCC983** | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 63 | Streptococcus anginosus | ATCC12395 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| | Organisms | Strain/ATCC ID | No target | | MRSA 10364<br>(NARSA 384) | | MRSA 8065<br>(ATCC 43300) | | SA 10851<br>(NARSA 164) | |
| | | | MRSA | SA | MRSA | SA | MRSA | SA | MRSA | SA |
| 64 | Streptococcus mitis | ATCC33399 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 65 | Streptococcus mutans | ATCC25175 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 66 | Streptococcus pneumoniae | ATCC33400 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 67 | Streptococcus pyogenes | ATCC12344 | NEG | NEG | POS | POS | POS | POS | NEG | POS |
| 68 | Streptococcus salivarius | ATCC7073 | NEG | NEG | POS | POS | POS…
