FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing The FDA “Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing” outlines recommended data and labeling elements to support EUA requests for screening claims that rely on serial testing rather than pre-authorization asymptomatic studies. It specifies expected serial testing intervals (typically twice over 2–3 days, 24–36 hours apart), clinical performance expectations (including PPA thresholds and confidence intervals for POC/at-home tests), and how these recommendations supplement the primary molecular/antigen EUA templates. It also describes likely post-authorization study conditions to establish asymptomatic performance and how results could affect continued authorization. primary file regulatory fda-policy 2021-03-16_FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing.md regulatory/fda-policy/2021-03-16_FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing.md 2021_03_16 docx docx Public Domain 1280 1998 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url