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

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.