FDA Fact Sheet - Fact Sheet for Healthcare Providers The FDA “Fact Sheet for Healthcare Providers – Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests” (updated Nov 15, 2021) provides standardized provider-facing risk/benefit, intended-use, and result-interpretation language for EUA-authorized molecular LDTs used on respiratory specimens from individuals suspected of COVID-19. It explains what positive and negative results mean, highlights false positive/false negative risks and variant-related performance limitations, and reiterates CLIA high-complexity and public health reporting expectations. It supports consistent communication to clinicians across laboratories operating under the molecular LDT umbrella EUA. primary file regulatory fda-policy 2021-11-15_FDA Fact Sheet - Fact Sheet for Healthcare Providers.md regulatory/fda-policy/2021-11-15_FDA Fact Sheet - Fact Sheet for Healthcare Providers.md 2021_11_15 pdf Public Domain 1457 2447 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