Evaluation of the BioFire® COVID-19 test and Respiratory Panel 2.1 for rapid identification of SARS-CoV-2 in nasopharyngeal swab samples.
COVID-19
/ diagnosis
COVID-19 Testing
/ methods
Clinical Laboratory Techniques
/ methods
Diagnostic Tests, Routine
Humans
Limit of Detection
Multiplex Polymerase Chain Reaction
Nasopharynx
/ virology
Real-Time Polymerase Chain Reaction
/ methods
Reproducibility of Results
SARS-CoV-2
/ isolation & purification
Sensitivity and Specificity
BioFire
COVID-19
FilmArray
Laboratory Developed Test
RP2.1
SARS-CoV-2
Journal
Diagnostic microbiology and infectious disease
ISSN: 1879-0070
Titre abrégé: Diagn Microbiol Infect Dis
Pays: United States
ID NLM: 8305899
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
08
06
2020
revised:
28
10
2020
accepted:
01
11
2020
pubmed:
20
12
2020
medline:
12
2
2021
entrez:
19
12
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 33340934
pii: S0732-8893(20)30637-4
doi: 10.1016/j.diagmicrobio.2020.115260
pmc: PMC7654322
pii:
doi:
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115260Informations de copyright
Copyright © 2020. Published by Elsevier Inc.
Références
Euro Surveill. 2020 Jan;25(3):
pubmed: 31992387
Emerg Microbes Infect. 2020 Dec;9(1):469-473
pubmed: 32102625
Lancet Infect Dis. 2020 Jun;20(6):656-657
pubmed: 32199493
Nature. 2020 May;581(7809):465-469
pubmed: 32235945
Nat Med. 2020 May;26(5):672-675
pubmed: 32296168
Clin Infect Dis. 2020 Jun 16;:
pubmed: 32556191
J Clin Microbiol. 2018 May 25;56(6):
pubmed: 29593057
JAMA. 2020 Apr 21;323(15):1502-1503
pubmed: 32105304