FDA Policy IVD - Sensitivity and Specificity Study Outline FULL STUDY The "2020-08-04_FDA Policy IVD - Sensitivity and Specificity Study Outline FULL STUDY" document is a step-by-step protocol for evaluating SARS-CoV-2 test performance using the FDA Verification Panel, including LoD determination/corroboration, dilution schemes, replicate testing, and blinded controls (T2–T5). It standardizes how developers generate and report Ct-based sensitivity/specificity results, plus a required Ct vs. log10 concentration plot, so the FDA can compare new and previously authorized COVID-19 assays under consistent conditions. primary file regulatory fda-policy 2020-08-04_FDA Policy IVD - Sensitivity and Specificity Study Outline FULL STUDY.md regulatory/fda-policy/2020-08-04_FDA Policy IVD - Sensitivity and Specificity Study Outline FULL STUDY.md 2020_08_04 docx docx Public Domain 1730 2684 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