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Estimating the False-Positive Rate of Highly Automated SARS-CoV-2 Nucleic Acid Amplification Testing

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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%… Click to show full abstract

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.

Keywords: positive rate; highly automated; rate highly; false positive; sars cov; estimating false

Journal Title: Journal of Clinical Microbiology
Year Published: 2021

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