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ASCP on antigen testing for COVID-19

Updated: Mar 29, 2023

The performance of antigen testing in microbiology is well understood as there is abundant literature and years of experience. Antigen tests for respiratory viral pathogens are less sensitive than reverse transcription polymerase chain reaction (RT-PCR) assays. Unfortunately, the limits of detection (LoD) of antigen tests are not included in the FDA webpage that compares the LoD of numerous molecular SARS-CoV-2 assays (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data).

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