Estimating the false positive rate of highly automated SARS-CoV-2 nucleic acid amplification testing

J Clin Microbiol. 2021 May 10;JCM.01080-21. doi: 10.1128/JCM.01080-21. Online ahead of print.


Molecular testing for infectious diseases is generally both very sensitive and specific (1). Well-designed PCR primers rarely cross-react with other analytes, and specificities seen during test validation are often 100% (2). However, analytical specificities measured during limited validation studies may not reflect real-world performance across the entire testing process. Surprisingly, there is exceedingly little literature on the specificity of high-throughput, sample-to-answer PCR testing, which critically informs debates on future SARS-CoV-2 screening algorithms.

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