Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA

Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA

In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.

This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.

Inclusion Criteria:

1. Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:

   • bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
   • bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic

2. Completion of the KeyPathTM BTA Test on the sample.

3. Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.

Exclusion Criteria:

1. Samples from blood culture positives over 24 hours from alarm
2. Samples deemed contaminated.
3. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.