Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD CORTM 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 CORTM 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 (R) 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.