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Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2
- Source :
- Journal of Clinical Virology
- Publication Year :
- 2020
- Publisher :
- The Authors. Published by Elsevier B.V., 2020.
-
Abstract
- Highlights • BioFire Respiratory Panel 2.1 SARS-CoV-2 assay high sensitivity and specificity. • Comparable performance to gold standard tests for low level viral RNA detection. • Rapid, sample-to-answer, syndromic testing for respiratory pathogens with SARS-CoV-2.<br />We evaluated the performance of the BioFire® Respiratory Panel 2.1 (RP2.1) in the detection of SARS CoV-2 in comparison against three other SARS CoV-2 EUA assays. In these studies, the RP2.1 panel had 98 % positive percent agreement (48/49) and 100 % negative percent agreement (49/49). Since 30 % of nasopharyngeal swab specimens have a SARS CoV-2 Ct >30 and thus detection of virus in low titers is clinically relevant, a sample with a high titer was diluted and each 10 fold dilution was tested in triplicate and compared against 6 other EUA approved SARS CoV-2 assays. These data suggested that the BioFire® RP2.1 panel, along with four other SARS CoV-2 assays (Roche cobas, Cepheid Xpert Xpress, BioFire® Defense COVID19, and NECoV19), consistently detected viral RNA at the 10−7 dilution. Overall, these studies suggest that the BioFire® RP2.1 assay can be used to detect acute cases of SARS CoV2 in addition to patients with low viral titer later in disease presentation.
- Subjects :
- 0301 basic medicine
2019-20 coronavirus outbreak
Coronavirus disease 2019 (COVID-19)
COVID19
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
viruses
Pneumonia, Viral
030106 microbiology
SARS CoV-2
Polymerase Chain Reaction
Sensitivity and Specificity
Virus
Article
Betacoronavirus
03 medical and health sciences
COVID-19 Testing
0302 clinical medicine
Nasopharynx
Virology
Humans
Medicine
Viral rna
030212 general & internal medicine
Respiratory system
skin and connective tissue diseases
Pandemics
Diagnostics
Clinical Laboratory Techniques
SARS-CoV-2
business.industry
fungi
COVID-19
respiratory tract diseases
body regions
Titer
Infectious Diseases
Molecular Diagnostic Techniques
RNA, Viral
Coronavirus Infections
business
Clinical evaluation
Subjects
Details
- Language :
- English
- ISSN :
- 18735967 and 13866532
- Volume :
- 129
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Virology
- Accession number :
- edsair.doi.dedup.....a40eccf670a6ddbe7b7a05a1689e6509