FDA Policy IVD - Pooled Sample Testing and Screening Testing for COVID-19 The FDA “Pooled Sample Testing and Screening Testing for COVID-19” policy summarizes federal recommendations and linked resources for validating and using SARS-CoV-2 IVDs in pooled-sample workflows and in screening of asymptomatic individuals. It defines pooled testing approaches (sample/media vs. swab pooling), highlights key validation expectations (including ≥85% PPA vs. individual testing) and reporting/CLIA considerations to mitigate dilution-driven false negatives. It also distinguishes screening from surveillance testing and provides practical guidance for providers on when highly sensitive tests, serial testing, and confirmatory testing may be appropriate. primary file regulatory fda-policy 2020-08-24_FDA Policy IVD - Pooled Sample Testing and Screening Testing for COVID-19.md regulatory/fda-policy/2020-08-24_FDA Policy IVD - Pooled Sample Testing and Screening Testing for COVID-19.md 2020_08_24 docx docx Public Domain 2001 3275 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