A-416 Clinical and Analytical Evaluation of the 15-minute, FDA-Cleared, CLIA-Waived, DASH® SARS-CoV-2 and Flu A/B Test Performed on the Point-of-Care DASH® Rapid PCR System

Abstract Background The FDA-Cleared, CLIA-waived, DASH® SARS-CoV-2 & Flu A/B Test is a rapid RT-PCR based molecular diagnostic test used at the point of care. The total turnaround time, sample to answer, is only 15 minutes. Here we report the results of a clinical and analytical evaluation of this test performed on the DASH® Rapid PCR Instrument. Methods The clinical performance was established in a multi-center study conducted from January to March 2024 using anterior nasal (AN) swab specimens collected from individuals with signs and symptoms of respiratory infection. Seven geographically diverse, CLIA-waived testing sites, within the United States, participated in the study. AN swabs were collected by either a healthcare provider or an adult from individuals below 14 years, and were self-collected from individuals aged 14 years or older. Additional AN swabs were collected in transport media for comparator testing. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated against FDA cleared RT-PCR tests to determine clinical sensitivity and specificity. All discordant results between the DASH® SARS-CoV-2 & Flu A/B Test and the comparator were investigated using a third, highly-sensitive FDA cleared test. Analytical evaluation was performed following FDA guidance and CLSI guidelines. Reproducibility was evaluated at three CLIA-waived sites. Results A total of 817 eligible subjects were enrolled, 22 were excluded due to protocol deviations (e.g., specimen shipping concerns causing the comparator sample to be ineligible for testing within the test IFU stability window, etc.). In total, 795 specimens were included in the calculations of performance for SARS-CoV-2, and 792 specimens for calculations of performance for Flu A and Flu B when tested on the DASH® SARS-CoV-2 & Flu A/B Test. Conclusion The FDA-cleared, CLIA-waived, DASH® SARS-CoV-2 & Flu A/B Test is a rapid and robust molecular diagnostic assay that is suitable for point-of-care use. The analytical performance and clinical performance are substantially equivalent to existing FDA cleared molecular diagnostic tests for SARS-CoV-2, Flu A, and Flu B. The DASH® Rapid PCR system delivers the benefits of simple, affordable, rapid, and accurate testing to respiratory patients at the point of care.