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.
| Original language | English (US) |
|---|---|
| Article number | e0270060 |
| Journal | PloS one |
| Volume | 17 |
| Issue number | 6 June |
| DOIs | |
| State | Published - Jun 2022 |
Funding
Funding provided by National Institutes for Health (NIH)/National Institute for Biomedical Imaging and Bioengineering (NIBIB)(https://www. nibib.nih.gov/), grant numbers U54EB027049-02S1 (PI is RLM) and U54EB027690 (Co-PIs are WAL and GSM). Minute Molecular Diagnostics, Inc. only provided DASH machines, cartridges, and nasal swabs. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. These findings are presented on behalf of the study participants who generously gave their time, samples, and information for this research. We would also like to thankfully acknowledge all staff and faculty in the NMH IDC, NMH CRU, Access Community Health Network, Emory RADxtra clinics, and NMH microbiology laboratory who contributed to this study. Emory investigators would like to acknowledge the following individual team members for their assistance with this study: Tamara Wesley, Tim Thurman, Kristi Godbolt, Anna Wood, Adrianna Westbrook, Leona Wells, Julie Sullivan, Cheryl L. Stone, and Jared O\u2019Neal. Northwestern and Access investigators would like to acknowledge the following individual team members for their assistance with this study: Kate Klein, Camille Bundy, Mackenzie Furnari-Stickney, Amelia Kelly, Jehannaz Dastoor, Michael Govern, Carol Govern, Kristen Weber, Elizabeth Christian, Adrianna Quintana, Patricia Helbin, and Vinay Durbhakula.
ASJC Scopus subject areas
- General
