Abstract
As the incidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) begins to overlap with the traditional respiratory season in the Northern Hemisphere, simultaneous testing for SARS-CoV-2 and the other common causes of respiratory infections is imperative. This has led to the development of multiplex respiratory assays that include SARS-CoV-2 as a target. One such assay is the BioFire respiratory panel 2.1 (RP2.1), which is an expansion of the original BioFire FilmArray respiratory panel 2 (RP2) to include SARS-CoV-2. In this multicenter evaluation, we assessed the performance characteristics of the BioFire RP2.1 for the detection of SARS-CoV-2. One or more targets on the panel were detected in 19.3% (101/524) of specimens tested, with SARS-CoV-2 detected in 12.6% (66/524) of specimens. Human rhinovirus/enterovirus was also detected in 32.7% (33/101) and adenovirus in 3.0% (3/101) of positive specimens, with one dual positive for both SARS-CoV-2 and adenovirus being detected. A further breakdown of pathogens by age revealed a 4-fold predominance of human rhinovirus/enterovirus in subjects 0 to 18 years of age, whereas in all other age groups, SARS-CoV-2 was clearly the predominant pathogen. Overall, SARS-CoV-2 results obtained from the BioFire RP2.1 were highly concordant with the composite result, exhibiting 98.4% (61/62) positive percent agreement (95% confidence interval [CI], 91.4 to 99.7%) and 98.9% (457/462) negative percent agreement (95% CI, 97.5 to 99.5%) with further analysis of discordant results suggesting that the concentration of SARS-CoV-2 in the specimens was near the limit of detection (LoD) for both the BioFire RP2.1 and the comparator assays. Overall, the BioFire RP2.1 exhibited excellent performance in the detection of SARS-CoV-2.
Keywords: BioFire; SARS-CoV-2; nasopharyngeal swabs; respiratory panel 2.1; respiratory pathogens.
【저자키워드】 SARS-CoV-2, nasopharyngeal swabs, Respiratory pathogens, BioFire, respiratory panel 2.1, 【초록키워드】 respiratory infections, coronavirus, Human, severe acute respiratory syndrome Coronavirus, Adenovirus, respiratory infection, Characteristics, pathogen, rhinovirus, nasopharyngeal swabs, nasopharyngeal, limit of detection, Respiratory pathogens, target, age, Pathogens, incidence, multicenter, expansion, multiplex, specimens, enterovirus, Concentration, Analysis, acute respiratory syndrome, overlap, 95% CI, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, 95% confidence interval, subject, specimen, positive, Human rhinovirus, tested, include, assays, exhibited, imperative, cause, groups, predominant, exhibiting, Hemisphere, RP2, 【제목키워드】 detection, respiratory, Sample, Panel,