Methods: A total of 526 isolates were tested across three sites by multiple operators. These included viruses, fungi, and bacteria, some of which contained antibiotic resistance markers. Inclusivity was assessed at a concentration of 105 CFU/mL, and specificity at 108 CFU/mL. Additionally, quantitative accuracy and consistency among strains were evaluated for commensal bacterial targets.
Results: Panel exclusivity was assessed using 232 species of on-panel organisms, phylogenetic-neighbors, and a representative subset of normal oropharyngeal flora, with 100% specificity observed for 38/40 targets. Inclusivity was confirmed for 194/194 qualitative target analytes, including antibiotic resistance markers, and for 190/190 quantitative target analytes. FA LRTI Panel quantification was within 0.5 log units of the test concentration for the majority of quantitative analytes across multiple strains. Titers of strains quantified above or below the expected level were concordant with titer estimates by other molecular methods.
Conclusion: These results indicate that the FA LRTI Panel will be able to identify numerous pathogens implicated in LRTI with a high degree of specificity. This study suggests that the FA LRTI Panel will be able to provide accurate quantification that is comparable to traditional microbiological methods.
The FilmArray LRTI Panel has not been evaluated by the FDA or other regulatory agencies for In Vitro Diagnostic use.
C. Li, BioFire Diagnostics: Employee , Salary
D. Nicholes, BioFire Diagnostics: Employee , Salary
E. Bonar, BioFire Diagnostics: Employee , Salary
C. Alberti-Segui, bioMerieux: Employee , Salary
C. Weber, bioMerieux: Employee , Salary
M. Casse, bioMerieux: Employee , Salary
M. Rogatcheva, BioFire Diagnostics: Employee , Salary
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