Clinical evaluation of the molecular-based BD SARS-CoV-2/Flu for the BD MAX™ system.
J Clin Virol
; 143: 104946, 2021 10.
Article
in English
| MEDLINE | ID: covidwho-1433478
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
ABSTRACT
BACKGROUND:
COVID-19 and influenza (flu) share similar clinical symptoms. Therefore, differential detection of these viruses during the respiratory virus season will be an important component for proper patient triage, management, and treatment.OBJECTIVES:
Establish the diagnostic performance related to SARS-CoV-2 and Flu A/B detection for the BD SARS-CoV-2/Flu for BD MAX™ System ("MAX SARS-CoV-2/Flu") multiplex assay. MATERIALS ANDMETHODS:
Two hundred and thirty-five (235) retrospective nasopharyngeal specimens were obtained from external vendors. The BD BioGx SARS-CoV-2 Reagents for BD MAX™ System ("BioGx SARS-CoV-2â³) and the Cepheid Xpert® Xpress Flu/RSV ("Xpert Flu/RSV") were utilized as reference methods.RESULTS:
By reference methods, 52 specimens were SARS-CoV-2-positive, 59 were Flu A-positive, and 60 were Flu B-positive. MAX SARS-CoV-2/Flu had positive percent agreement (PPA) and negative percent agreement (NPA) values for SARS-CoV-2 detection of 96.2% ([95%CI]87.0-98.9) and 100% [95%CI88.7-100], respectively; PPA values for Flu A and Flu B of 100% [95%CI93.9-100] and 98.3% [95%CI91.1-99.7], respectively, and NPA values for Flu A and Flu B of 98.9% [95%CI94.0-99.8] and 100% [95%CI95.9-100], respectively.CONCLUSIONS:
The MAX SARS-CoV-2/Flu assay met FDA-EUA performance criteria for SARS-CoV-2 (≥95% for PPA and NPA) and FDA clearance criteria for Flu A/B (PPA ≥90%; lower bound of the 95%CI ≥80% and NPA ≥95%; lower bound of the 95%CI ≥90%).Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Influenza, Human
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
J Clin Virol
Journal subject:
Virology
Year:
2021
Document Type:
Article
Affiliation country:
J.jcv.2021.104946
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