tetano
Editor, Senior Moderator
Diagn Microbiol Infect Dis
. 2020 Nov 10;99(3):115260.
doi: 10.1016/j.diagmicrobio.2020.115260. Online ahead of print.
Evaluation of the BioFire? COVID-19 test and Respiratory Panel 2.1 for rapid identification of SARS-CoV-2 in nasopharyngeal swab samples
Eric J Eckbo[SUP] 1 [/SUP], Kerstin Locher[SUP] 1 [/SUP], Melissa Caza[SUP] 2 [/SUP], Lisa Li[SUP] 1 [/SUP], Valery Lavergne[SUP] 2 [/SUP], Marthe Charles[SUP] 3 [/SUP]
Affiliations
Abstract
The BioFire? COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs. In the case of the RP2.1, an additional 21 viral and bacterial pathogens can be detected. Both tests have received emergency use authorization from the U.S. Food & Drug Administration and Interim Order authorization from Health Canada for use in clinical laboratories. We evaluated the performance characteristics of these tests in comparison to a laboratory-developed real-time PCR assay targeting the viral RNA-dependent RNA polymerase and E genes. A total of 78 tests were performed using the BioFire COVID-19 Test, including 30 clinical specimens and 48 tests in a limit of detection study; 57 tests were performed using the RP2.1 for evaluation of SARS-CoV-2 detection, including 30 clinical specimens and 27 tests for limit of detection. Results showed 100% concordance between the BioFire assays and the laboratory-developed test for all clinical samples tested, and acceptable performance of both BioFire assays at their stated limits of detection. Conclusively, the BioFire COVID-19 Test and RP2.1 are highly sensitive assays that can be effectively used in the clinical laboratory for rapid SARS-CoV-2 testing.
Keywords: BioFire; COVID-19; FilmArray; Laboratory Developed Test; RP2.1; SARS-CoV-2.
. 2020 Nov 10;99(3):115260.
doi: 10.1016/j.diagmicrobio.2020.115260. Online ahead of print.
Evaluation of the BioFire? COVID-19 test and Respiratory Panel 2.1 for rapid identification of SARS-CoV-2 in nasopharyngeal swab samples
Eric J Eckbo[SUP] 1 [/SUP], Kerstin Locher[SUP] 1 [/SUP], Melissa Caza[SUP] 2 [/SUP], Lisa Li[SUP] 1 [/SUP], Valery Lavergne[SUP] 2 [/SUP], Marthe Charles[SUP] 3 [/SUP]
Affiliations
- PMID: 33340934
- PMCID: PMC7654322
- DOI: 10.1016/j.diagmicrobio.2020.115260
Abstract
The BioFire? COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs. In the case of the RP2.1, an additional 21 viral and bacterial pathogens can be detected. Both tests have received emergency use authorization from the U.S. Food & Drug Administration and Interim Order authorization from Health Canada for use in clinical laboratories. We evaluated the performance characteristics of these tests in comparison to a laboratory-developed real-time PCR assay targeting the viral RNA-dependent RNA polymerase and E genes. A total of 78 tests were performed using the BioFire COVID-19 Test, including 30 clinical specimens and 48 tests in a limit of detection study; 57 tests were performed using the RP2.1 for evaluation of SARS-CoV-2 detection, including 30 clinical specimens and 27 tests for limit of detection. Results showed 100% concordance between the BioFire assays and the laboratory-developed test for all clinical samples tested, and acceptable performance of both BioFire assays at their stated limits of detection. Conclusively, the BioFire COVID-19 Test and RP2.1 are highly sensitive assays that can be effectively used in the clinical laboratory for rapid SARS-CoV-2 testing.
Keywords: BioFire; COVID-19; FilmArray; Laboratory Developed Test; RP2.1; SARS-CoV-2.