Comprehensive analytical and clinical evaluation of a RNA extraction-free saliva-based molecular assay for SARS-CoV-2.

Autor: Schoeber JPH; Research Group Applied Natural Sciences, Fontys University of Applied Sciences, Eindhoven, The Netherlands., Schlaghecke JM; Research Group Applied Natural Sciences, Fontys University of Applied Sciences, Eindhoven, The Netherlands., Meuwissen BMJ; Research Group Applied Natural Sciences, Fontys University of Applied Sciences, Eindhoven, The Netherlands., van Heertum M; Research Group Applied Natural Sciences, Fontys University of Applied Sciences, Eindhoven, The Netherlands., van den Brule AJC; Pathologie-DNA, Lab for Molecular Diagnostics, Location Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands., Loonen AJM; Research Group Applied Natural Sciences, Fontys University of Applied Sciences, Eindhoven, The Netherlands.; Pathologie-DNA, Lab for Molecular Diagnostics, Location Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 May 05; Vol. 17 (5), pp. e0268082. Date of Electronic Publication: 2022 May 05 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0268082
Abstrakt: Standard SARS-CoV-2 testing protocols using nasopharyngeal/throat (NP/T) swabs are invasive and require trained medical staff for reliable sampling. In addition, it has been shown that PCR is more sensitive as compared to antigen-based tests. Here we describe the analytical and clinical evaluation of our in-house RNA extraction-free saliva-based molecular assay for the detection of SARS-CoV-2. Analytical sensitivity of the test was equal to the sensitivity obtained in other Dutch diagnostic laboratories that process NP/T swabs. In this study, 955 individuals participated and provided NP/T swabs for routine molecular analysis (with RNA extraction) and saliva for comparison. Our RT-qPCR resulted in a sensitivity of 82,86% and a specificity of 98,94% compared to the gold standard. A false-negative ratio of 1,9% was found. The SARS-CoV-2 detection workflow described here enables easy, economical, and reliable saliva processing, useful for repeated testing of individuals.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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