MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial

Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.

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

This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.

Inclusion Criteria:

• Over 18 years of age.
• Blood culture positive, of ANY of the following bottle types:
• BD Bactec Standard Aerobic and Anaerobic,
• BD Bactec Plus Aerobic and Anaerobic,
• bioMerieux BacT/Alert Standard Aerobic and Anaerobic,
• bioMerieux BacT/Alert FAN Aerobic and Anaerobic.

Exclusion Criteria:

• BD Bactec Lytic, Pediatric, or other bottle types not listed above.
• bioMerieux Pediatric FAN or other bottle types listed above.
• Trek bottles.
• Specimens from patients under 18 years of age.