Abstract
Background: 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.
Methods: 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”.
Results: We enrolled 315 and analyzed 313 participants with median age 42 years; 65% were female, 62% symptomatic, 75% had received ≥2 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]).
Conclusions: 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.
【초록키워드】 COVID-19, SARS-CoV-2, COVID-19 vaccine, vaccination, cross-sectional, POC, Predictive value, Laboratory, Antigen, point-of-care, sensitivity, specificity, cross-sectional study, PCR, Concordance, Positive predictive value, mRNA, symptomatic, female, gold, Swab, nasal swab, Cepheid, PCR test, information, speed, COVID-19 symptoms, dose, SARS-CoV-2 PCR, Negative predictive value, Predictive, gold standard, median age, participant, clinical setting, doses, symptoms of COVID-19, hybridization, positive, DASH, enrolled, analyzed, performed, collected, evaluated, conducted, provided, calculated, correlated, Analyzer, negative and positive, was tested, without symptom, 【제목키워드】 SARS-COV-2 infection, point-of-care, clinical, PCR test, hybridization, Analyzer,