FDA Policy IVD - Sensitivity and Specificity Study Outline ABBREVIATED STUDY The FDA Sensitivity and Specificity Study Outline (Abbreviated/Minimum Requirement) specifies a standardized protocol for evaluating SARS-CoV-2 diagnostic device performance using the FDA SARS-CoV-2 Reference Panel, including matrix suitability checks, LoD range-finding and confirmation (up to 20 replicates), and Ct-based reporting. It guides manufacturers on preparing dilution series, running blinded controls (T2–T5), and summarizing results (including a mean Ct vs log10 concentration plot) so FDA can compare new devices against previously authorized tests. primary file regulatory fda-policy 2020-08-04_FDA Policy IVD - Sensitivity and Specificity Study Outline ABBREVIATED STUDY.md regulatory/fda-policy/2020-08-04_FDA Policy IVD - Sensitivity and Specificity Study Outline ABBREVIATED STUDY.md 2020_08_04 docx docx Public Domain 1817 2787 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