Clinical evaluation of the Diagnostic Analyzer for Selective Hybridization (DASH): A point-of-care PCR test for rapid detection of SARS-CoV-2 infection.

Autor: Achenbach CJ; Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America.; Department of Medicine, Division of Infectious Diseases, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America.; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America., Caputo M; Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America., Hawkins C; Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America.; Department of Medicine, Division of Infectious Diseases, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America., Balmert LC; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America., Qi C; Department of Pathology, Northwestern University, Evanston, IL, United States of America., Odorisio J; Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America., Dembele E; Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America., Jackson A; Access Community Health Network, Chicago, IL, United States of America., Abbas H; Access Community Health Network, Chicago, IL, United States of America., Frediani JK; Atlanta Center for Microsystems Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.; Emory University Nell Hodgson Woodruff School of Nursing, Atlanta, GA, United States of America., Levy JM; Atlanta Center for Microsystems Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.; Emory University Department of Otolaryngology, Atlanta, GA, United States of America., Rebolledo PA; Atlanta Center for Microsystems Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.; Emory University Division of Infectious Diseases, Atlanta, GA, United States of America., Kempker RR; Atlanta Center for Microsystems Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.; Emory University Division of Infectious Diseases, Atlanta, GA, United States of America., Esper AM; Atlanta Center for Microsystems Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.; Emory University Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Atlanta, GA, United States of America., Lam WA; Atlanta Center for Microsystems Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.; Emory University Department of Pediatrics, Atlanta, GA, United States of America., Martin GS; Atlanta Center for Microsystems Engineered Point-of-Care Technologies, Atlanta, GA, United States of America.; Emory University Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Atlanta, GA, United States of America., Murphy RL; Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America.; Department of Medicine, Division of Infectious Diseases, Feinberg School of Medicine, Northwestern University, Evanston, IL, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 Jun 16; Vol. 17 (6), pp. e0270060. Date of Electronic Publication: 2022 Jun 16 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0270060
Abstrakt: 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.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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