Detection of SARS-CoV-2 infection in asymptomatic populations using the DiaSorin molecular Simplexa and Roche Cobas EUA assays

Detection of SARS-CoV-2 infection in asymptomatic populations using the DiaSorin molecular Simplexa and Roche Cobas EUA assays

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) as...

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Bibliographic Details
Published in:Diagnostic microbiology and infectious disease Vol. 102; no. 1; p. 115513
Main Authors: Antonara, Stella, Ozbolt, Patrick, Landon, Lorie, Fatica, Lisa, Pleasant, Tamra, Swickard, Juanita, Drury, Andrew, Wongchaowart, Nicholas, Cradic, Kendall W
Format: Journal Article
Language:English
Published: United States Elsevier Inc 01-01-2022
Subjects:
Antibodies, Viral - analysis
Asymptomatic
Asymptomatic Infections
COVID-19
COVID-19 - diagnosis
COVID-19 Testing - methods
EUA
Humans
Oropharyngeal
Performance comparison
SARS-CoV-2
SARS-CoV-2 - isolation & purification
Sensitivity and Specificity
Virology
COVID-19
EUA
Oropharyngeal
SARS-CoV-2
Performance comparison
Asymptomatic
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Summary: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.
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ISSN:0732-8893
1879-0070
DOI:10.1016/j.diagmicrobio.2021.115513