Exploring beyond the limit: How comparative stochastic performance affects retesting outcomes in six commercial SARS CoV-2 nucleic acid amplification tests

Autor: Hiu Tat Chan, Marco H.T. Keung, Ivy Nguyen, Ellen L.O. Ip, Su M. Chew, Danielle Siler, Marion Saville, David Hawkes
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Journal of Clinical Virology Plus, Vol 2, Iss 3, Pp 100079- (2022)
Druh dokumentu: article
ISSN: 2667-0380
DOI: 10.1016/j.jcvp.2022.100079
Popis: Objectives: To examine the comparative stochasticity profile of six commercial SARS-CoV-2 nucleic acid amplification tests (NAATs) and how this may affect retesting paradigms. Methods: Commercial quality control (QC) material was serially diluted in viral transport media to create a panel covering 10–10,000 copies/ml. The panel was tested across six commercial NAATs. A subset of high cycle threshold results was retested on a rapid PCR assay to simulate retesting protocols commonly used to discriminate false positives. Results: Performance beyond the LOD differed among assays, with three types of stochasticity profiles observed. The ability of the rapid PCR assay to reproduce a true weak positive specimen was restricted to its own stochastic performance at the corresponding viral concentration. Conclusion: Stochastic performance of various NAATs overlap across low viral concentrations and affect retesting outcomes. Relying on retesting alone to discriminate false positives risk missing true positives even when a more sensitive assay is deployed for confirmatory testing.
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