Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System

Background: Differentiating between SARS-CoV-2 and Influenza (flu) A and B is often difficult without laboratory testing as the symptomology of these respiratory viral infections overlap. Objective: Evaluate the clinical performance of the BD COR™ System multiplex assay (COR SC2/Flu) to detect the t...

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Main Authors: Elizabeth Lockamy, Rebekah M. Martin, Jordan Ippolito
Format: Article
Language:English
Published: Elsevier 2023-11-01
Series:Journal of Clinical Virology Plus
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2667038023000376
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author Elizabeth Lockamy
Rebekah M. Martin
Jordan Ippolito
author_facet Elizabeth Lockamy
Rebekah M. Martin
Jordan Ippolito
author_sort Elizabeth Lockamy
collection DOAJ
description Background: Differentiating between SARS-CoV-2 and Influenza (flu) A and B is often difficult without laboratory testing as the symptomology of these respiratory viral infections overlap. Objective: Evaluate the clinical performance of the BD COR™ System multiplex assay (COR SC2/Flu) to detect the three viral pathogens using single nasopharyngeal (NP) swabs collected from symptomatic and asymptomatic individuals. Materials and methods: Swabs collected from 203 symptomatic and 144 asymptomatic individuals were tested using COR SC2/Flu. Results were compared to those from the BioFire® Respiratory Panel 2.1 (BioFire RP2.1) and positive and negative percent agreements (PPA and NPA, respectively) with 95% confidence intervals were calculated. Results: For asymptomatic individuals (n = 144), PPA between COR SC2/Flu and BioFire RP2.1 was 100% (95% CI: 79.6–100) and NPA was 97.7% (95% CI: 93.4–99.2) for the SARS-CoV-2 target. For symptomatic individuals (n = 203), PPA was 100% (95% CI: 92.9–100) and NPA 99.3% (95% CI: 96.4–99.9) for the SARS-CoV-2 target. PPA was 94.0% (95% CI: 83.8–97.9) and NPA was 98.7% (95% CI: 95.4–99.6) for the flu A target. PPA was 100% (95% CI: 92.9–100) and NPA was 100% (95% CI: 97.6–100) for flu B. Conclusion: The continued development and validation of multiplex assays to detect SARS-CoV-2, flu A, and flu B should remain a crucial component of diagnostics as these viruses will continue to coexist in the post-pandemic environment. COR SC2/Flu assay performance met the predetermined clinical specifications for PPA and NPA for SARS-CoV-2, flu A, and flu B detection, and should help support infection control efforts of those diseases.
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spelling doaj.art-23cc0924440042cd9c7104af5c04b0472023-11-17T05:28:36ZengElsevierJournal of Clinical Virology Plus2667-03802023-11-0134100170Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ SystemElizabeth Lockamy0Rebekah M. Martin1Jordan Ippolito2Corresponding author.; Becton, Dickinson and Company, BD Life Sciences – Integrated Diagnostic Solutions, 7 Loveton Circle, Sparks, MD 21152, United StatesBecton, Dickinson and Company, BD Life Sciences – Integrated Diagnostic Solutions, 7 Loveton Circle, Sparks, MD 21152, United StatesBecton, Dickinson and Company, BD Life Sciences – Integrated Diagnostic Solutions, 7 Loveton Circle, Sparks, MD 21152, United StatesBackground: Differentiating between SARS-CoV-2 and Influenza (flu) A and B is often difficult without laboratory testing as the symptomology of these respiratory viral infections overlap. Objective: Evaluate the clinical performance of the BD COR™ System multiplex assay (COR SC2/Flu) to detect the three viral pathogens using single nasopharyngeal (NP) swabs collected from symptomatic and asymptomatic individuals. Materials and methods: Swabs collected from 203 symptomatic and 144 asymptomatic individuals were tested using COR SC2/Flu. Results were compared to those from the BioFire® Respiratory Panel 2.1 (BioFire RP2.1) and positive and negative percent agreements (PPA and NPA, respectively) with 95% confidence intervals were calculated. Results: For asymptomatic individuals (n = 144), PPA between COR SC2/Flu and BioFire RP2.1 was 100% (95% CI: 79.6–100) and NPA was 97.7% (95% CI: 93.4–99.2) for the SARS-CoV-2 target. For symptomatic individuals (n = 203), PPA was 100% (95% CI: 92.9–100) and NPA 99.3% (95% CI: 96.4–99.9) for the SARS-CoV-2 target. PPA was 94.0% (95% CI: 83.8–97.9) and NPA was 98.7% (95% CI: 95.4–99.6) for the flu A target. PPA was 100% (95% CI: 92.9–100) and NPA was 100% (95% CI: 97.6–100) for flu B. Conclusion: The continued development and validation of multiplex assays to detect SARS-CoV-2, flu A, and flu B should remain a crucial component of diagnostics as these viruses will continue to coexist in the post-pandemic environment. COR SC2/Flu assay performance met the predetermined clinical specifications for PPA and NPA for SARS-CoV-2, flu A, and flu B detection, and should help support infection control efforts of those diseases.http://www.sciencedirect.com/science/article/pii/S2667038023000376BD CORCOVID-19SARS-CoV-2InfluenzaMultiplex RT-PCR assay
spellingShingle Elizabeth Lockamy
Rebekah M. Martin
Jordan Ippolito
Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System
Journal of Clinical Virology Plus
BD COR
COVID-19
SARS-CoV-2
Influenza
Multiplex RT-PCR assay
title Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System
title_full Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System
title_fullStr Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System
title_full_unstemmed Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System
title_short Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System
title_sort evaluation of the clinical performance of bd sars cov 2 flu assay for bd cor™ system
topic BD COR
COVID-19
SARS-CoV-2
Influenza
Multiplex RT-PCR assay
url http://www.sciencedirect.com/science/article/pii/S2667038023000376
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