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.
Study Type
OBSERVATIONAL
Enrollment
712
In vitro diagnostic: The MicroPhage "Intervention" was to perform the MicroPhage diagnostic test to detect S. aureus in the blood culture sample and determine MSSA or MRSA status at 4 and 5 hours of test incubation. The "Intervention" results were not made available to the patient or their physician.
Evanston Northwestern Healthcare Research Institute
Evanston, Illinois, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, United States
Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.
Time frame: Within 48 hours
Qualitative feedback on the preliminary MicroPhage test protocol.
Comparative results to market-available S. aureus / MRSA tests for Blood Culture.
Time frame: Within 48 hours
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