FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing The "2021-03-16_FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing" document outlines recommended data and labeling elements to support EUA requests for screening claims that rely on serial testing. 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