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

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.