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  • Clinical evaluation of the ...
    Achenbach, Chad J; Caputo, Matthew; Hawkins, Claudia; Balmert, Lauren C; Qi, Chao; Odorisio, Joseph; Dembele, Etienne; Jackson, Alema; Abbas, Hiba; Frediani, Jennifer K; Levy, Joshua M; Rebolledo, Paulina A; Kempker, Russell R; Esper, Annette M; Lam, Wilbur A; Martin, Greg S; Murphy, Robert L

    PloS one, 06/2022, Volume: 17, Issue: 6
    Journal Article

    An ideal test for COVID-19 would combine the sensitivity of laboratory-based PCR with the speed and ease of use of point-of-care (POC) or home-based rapid antigen testing. We evaluated clinical performance of the Diagnostic Analyzer for Selective Hybridization (DASH) SARS-CoV-2 POC rapid PCR test. We conducted a cross-sectional study of adults with and without symptoms of COVID-19 at four clinical sites where we collected two bilateral anterior nasal swabs and information on COVID-19 symptoms, vaccination, and exposure. One swab was tested with the DASH SARS-CoV-2 POC PCR and the second in a central laboratory using Cepheid Xpert Xpress SARS-CoV-2 PCR. We assessed test concordance and calculated sensitivity, specificity, negative and positive predictive values using Xpert as the "gold standard". We enrolled 315 and analyzed 313 participants with median age 42 years; 65% were female, 62% symptomatic, 75% had received greater than or equal to2 doses of mRNA COVID-19 vaccine, and 16% currently SARS-CoV-2 positive. There were concordant results for 307 tests indicating an overall agreement for DASH of 0.98 95% CI 0.96, 0.99 compared to Xpert. DASH performed at 0.96 95% CI 0.86, 1.00 sensitivity and 0.98 95% CI 0.96, 1.00 specificity, with a positive predictive value of 0.85 95% CI 0.73, 0.96 and negative predictive value of 0.996 95% CI 0.99, 1.00. The six discordant tests between DASH and Xpert all had high Ct values (>30) on the respective positive assay. DASH and Xpert Ct values were highly correlated (R = 0.89 95% CI 0.81, 0.94). DASH POC SARS-CoV-2 PCR was accurate, easy to use, and provided fast results (approximately 15 minutes) in real-life clinical settings with an overall performance similar to an EUA-approved laboratory-based PCR.