In:
PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 6 ( 2022-6-16), p. e0270060-
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0270060
DOI:
10.1371/journal.pone.0270060.g001
DOI:
10.1371/journal.pone.0270060.g002
DOI:
10.1371/journal.pone.0270060.g003
DOI:
10.1371/journal.pone.0270060.g004
DOI:
10.1371/journal.pone.0270060.t001
DOI:
10.1371/journal.pone.0270060.t002
DOI:
10.1371/journal.pone.0270060.t003
DOI:
10.1371/journal.pone.0270060.t004
DOI:
10.1371/journal.pone.0270060.s001
DOI:
10.1371/journal.pone.0270060.s002
DOI:
10.1371/journal.pone.0270060.s003
DOI:
10.1371/journal.pone.0270060.s004
DOI:
10.1371/journal.pone.0270060.r001
DOI:
10.1371/journal.pone.0270060.r002
DOI:
10.1371/journal.pone.0270060.r003
DOI:
10.1371/journal.pone.0270060.r004
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2022
detail.hit.zdb_id:
2267670-3
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