From the Guidelines
BioFire FilmArray Blood Culture Identification Panel has a high sensitivity for detecting bloodstream infections, with studies showing improved therapeutic management of patients with bloodstream infections (BSIs) when using this rapid molecular method 1. The sensitivity of BioFire (FilmArray) blood Polymerase Chain Reaction (PCR) is supported by a strong recommendation from the Italian Society of Infection and Tropical Diseases, which emphasizes the importance of rapid molecular identification of micro-organisms from blood cultures and their resistance mechanisms in the laboratory workflow scheme 1.
- The BioFire FilmArray Blood Culture Identification Panel can identify 24 micro-organisms and three antimicrobial resistance genes (mecA, vanA/B and blaKPC) in 1 hour 5 minutes directly from blood of positive culture bottles 1.
- A study by Verroken et al. showed that the median time of administration of optimal antibiotic therapy in patients with BSIs was 4.7 hours using a rapid molecular method compared with 14.7 hours using a rapid phenotypic method, and that these results improved the therapeutic management of 31 of 110 patients studied 1.
- The test is particularly valuable for patients who have already received antibiotics, as it can detect pathogens even when traditional blood cultures might be negative.
- However, sensitivity may be lower for certain organisms or in cases with very low pathogen loads, and false negatives can occur, so negative results should be interpreted in the context of clinical presentation.
- The test works by amplifying and detecting specific nucleic acid sequences from pathogens, allowing for rapid identification without waiting for organism growth.
- While highly sensitive, BioFire Blood PCR should complement rather than replace traditional blood cultures, which remain important for antimicrobial susceptibility testing and recovery of organisms not included in the PCR panel.
From the Research
Sensitivity of BioFire (FilmArray) Blood Polymerase Chain Reaction (PCR)
- The sensitivity of BioFire (FilmArray) blood PCR has been evaluated in several studies:
- A 2016 study 2 reported that the FilmArray blood culture identification panel demonstrated an unresolved blood culture identification sensitivity for all target detections exceeding 96%, except for Klebsiella oxytoca (92.2%).
- A 2023 study 3 found that the BIOFIRE BCID2 Panel demonstrated an overall sensitivity of 98.9% for Gram-positive bacteria, Gram-negative bacteria, and yeast targets.
- A 2022 study 4 evaluated the next-generation FilmArray Blood Culture Identification 2 panel and reported a sensitivity of 98.8% for detecting microbial species.
- These studies suggest that the BioFire (FilmArray) blood PCR has a high sensitivity for detecting a wide range of pathogens, including bacteria, yeast, and antimicrobial resistance genes.
- However, it is essential to note that the sensitivity of the test may vary depending on the specific panel used and the type of pathogens being detected, as seen in the 2016 study 2 where Klebsiella oxytoca had a lower sensitivity.
- Other studies, such as the 2022 study 5 and the 2023 study 6, evaluated different diagnostic methods, including PCR-based syndromic testing and digital droplet PCR, but did not specifically focus on the BioFire (FilmArray) blood PCR.