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