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

Abstract

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.