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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Format: | Article |
Language: | English |
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Elsevier
2023-11-01
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Series: | Journal of Clinical Virology Plus |
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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. |
first_indexed | 2024-03-11T07:32:38Z |
format | Article |
id | doaj.art-23cc0924440042cd9c7104af5c04b047 |
institution | Directory Open Access Journal |
issn | 2667-0380 |
language | English |
last_indexed | 2024-03-11T07:32:38Z |
publishDate | 2023-11-01 |
publisher | Elsevier |
record_format | Article |
series | Journal of Clinical Virology Plus |
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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