A-380 Comparative Analytical Evaluation of Point-of-Care and Centralized Respiratory Assays For Detection of SARS-CoV-2, Influenza, and RSV

Abstract

The clinical and operational pressure to provide rapid, accurate respiratory diagnostics demands a strategy that leverages point-of-care and high-throughput assays/systems across the continuum of care. A central tenet of defining any co-existence strategy is to understand the comparative performance characteristics of the chosen assays/systems to be deployed within a diagnostic algorithm. This study compared the ability of two CLIA-waived and two moderate complexity multiplex respiratory assays to detect quantified viral samples at a range of low viral titers. A two-phase study, inclusive of a range-finding and confirmation arm, was conducted using a quantified control material for viral respiratory targets diluted into viral transport media. A 10-fold serial dilution was performed, and replicates (6 for range-finding, 20 for confirmation) of each concentration were evaluated on four multiplex respiratory assays: cobas® liat SARS-CoV-2 & Influenza A/B assay, cobas® liat SARS-CoV-2, Influenza A/B, & RSV assay, cobas® SARS-CoV-2, & Influenza A/B v2 assay, and the cobas® Respiratory 4-flex assay. Analyte detection rates and Ct values were compared across assays. Preliminary data indicates that the assays evaluated in this study have similar performance for low titer samples. Similar detection rates were observed for all assays across all concentrations tested These findings demonstrate that respiratory assays performed on the cobas® liat and cobas® x800 systems provide similar detections at low viral concentrations. This data validates the use of highly sensitive point-of-care tools alongside centralized systems, ensuring that a multifaceted testing strategy delivers consistent and accurate results regardless of the platform used.