tetano
Editor, Senior Moderator
J Clin Microbiol
. 2022 Apr 7;e0006622.
doi: 10.1128/jcm.00066-22. Online ahead of print.
Multicenter Evaluation of the BioFire Respiratory Panel 2.1 (RP2.1) for Detection of SARS-CoV-2 in Nasopharyngeal Swab Samples
Gregory J Berry[SUP] 1 2 [/SUP], Wei Zhen[SUP] 1 [/SUP], Elizabeth Smith[SUP] 1 [/SUP], Ryhana Manji[SUP] 1 [/SUP], Suzane Silbert[SUP] 3 [/SUP], Amorce Lima[SUP] 3 [/SUP], Amanda Harington[SUP] 4 [/SUP], Kathleen McKinley[SUP] 4 [/SUP], Bart Kensinger[SUP] 5 [/SUP], Crissy Neff[SUP] 5 [/SUP], Daisy Lu[SUP] 5 [/SUP]
Affiliations
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.
. 2022 Apr 7;e0006622.
doi: 10.1128/jcm.00066-22. Online ahead of print.
Multicenter Evaluation of the BioFire Respiratory Panel 2.1 (RP2.1) for Detection of SARS-CoV-2 in Nasopharyngeal Swab Samples
Gregory J Berry[SUP] 1 2 [/SUP], Wei Zhen[SUP] 1 [/SUP], Elizabeth Smith[SUP] 1 [/SUP], Ryhana Manji[SUP] 1 [/SUP], Suzane Silbert[SUP] 3 [/SUP], Amorce Lima[SUP] 3 [/SUP], Amanda Harington[SUP] 4 [/SUP], Kathleen McKinley[SUP] 4 [/SUP], Bart Kensinger[SUP] 5 [/SUP], Crissy Neff[SUP] 5 [/SUP], Daisy Lu[SUP] 5 [/SUP]
Affiliations
- PMID: 35387475
- DOI: 10.1128/jcm.00066-22
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.