Detection of SARS-CoV-2 infection in asymptomatic populations using the DiaSorin molecular Simplexa and Roche Cobas EUA assays.
Document Type
Article
Publication Title
Diagnostic microbiology and infectious disease
Abstract
Identification of asymptomatic patients is necessary to control the COVID-19 pandemic and testing is one of the measures to detect this population. We evaluated the clinical correlation of the DiaSorin Molecular Simplexa COVID-19 Direct (DiaSorin Molecular) and Roche Cobas 6800 SARS-CoV-2 (Roche) assays using 253 oropharyngeal (OP) swab specimens collected from asymptomatic patients. Agreement between DiaSorin Molecular and Roche was 97% (95% CI, 0.94 to 0.99), with a κ statistic of 0.90 (95% CI, 0.83 to 0.97) and a PPA of 89% (95% CI, 0.76 to 0.96) and NPA of 99% (95% CI, 0.97 to 0.99). Simple regression analysis of Ct values revealed a regression line of y = 1.065*X - 5.537 with a Pearson's r of 0.8542, indicating a good correlation between both platforms. The DiaSorin Molecular assay demonstrates clinical performance comparable to that of Roche in this population.
First Page
115513
Last Page
115513
DOI
10.1016/j.diagmicrobio.2021.115513
Publication Date
1-1-2022
Recommended Citation
Antonara S, Ozbolt P, Landon L, Fatica L, Pleasant T, Swickard J, Drury A, Wongchaowart N, Cradic KW. Detection of SARS-CoV-2 infection in asymptomatic populations using the DiaSorin molecular Simplexa and Roche Cobas EUA assays. Diagn Microbiol Infect Dis. 2022 Jan;102(1):115513. doi: 10.1016/j.diagmicrobio.2021.115513. Epub 2021 Jul 31. PMID: 34649190; PMCID: PMC8324421.