False Negative Tests for SARS-CoV-2 Infection—Challenges and Implications

While much debate about COVID-19 testing focused on test availability and antibody test accuracy, the authors highlight that false negative results from diagnostic RT-PCR tests may prove a larger long-term problem for containment efforts. The analysis examines how FDA Emergency Use Authorization validation methods, including the use of contrived specimens and known positive samples rather than natural clinical specimens with independent adjudication, may overestimate test sensitivity, with significant implications for public health strategies relying on testing to reopen society.