From the Research
The BioFire FilmArray blood PCR test has a sensitivity of 96.5% and a specificity of 99.7% for pathogen identification, with a false positive rate generally less than 2%, as demonstrated by the most recent and highest quality study 1.
Key Points
- The sensitivity of the BioFire FilmArray blood PCR test ranges from 80-95% depending on the specific pathogen, as reported in various studies 2, 1.
- The false positive rate is generally very low, typically less than 2%, which is achieved through careful assay design and internal controls to verify test performance 2, 1.
- Contamination during sample collection can occasionally lead to false positives, emphasizing the importance of proper aseptic technique 3.
- The test's rapid turnaround time of about 1-2 hours makes it valuable for guiding early antimicrobial therapy in critically ill patients, potentially improving outcomes by enabling targeted treatment sooner 1.
Evidence Summary
The study by 1 evaluated the diagnostic performance of the BioFire FilmArray blood culture identification panel in critically ill patients with sepsis, demonstrating high sensitivity and specificity for pathogen identification. Another study by 2 compared the sensitivity and specificity of the FilmArray blood culture identification panel with those of standard phenotypic identification techniques, showing high sensitivity and specificity for most target detections. However, the study by 4 highlighted the importance of interpreting diagnostic results together with clinical presentation and other available microbiological results, as false-positive results can occur.
Clinical Implications
The BioFire FilmArray blood PCR test is a valuable tool for guiding early antimicrobial therapy in critically ill patients, potentially improving outcomes by enabling targeted treatment sooner. However, it is essential to interpret test results in the context of clinical presentation and other diagnostic tests to ensure accuracy and minimize the risk of false positives. Proper aseptic technique during sample collection is also crucial to prevent contamination and false positive results.