CDC EUA IFU - CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel The CDC “2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel” EUA Instructions for Use detail how CLIA high-complexity laboratories perform, analyze, and report the CDC N1/N2/RP RT-PCR assay for SARS-CoV-2 across authorized respiratory specimen types. It provides end-to-end workflows for reagent prep, nucleic acid extraction options, ABI 7500 Fast Dx run setup, controls/interpretation rules, and performance characteristics (including LoD and specificity). It also includes appendices for heat-treatment as an extraction alternative and for pooled testing (up to 4 specimens) with guidance on implementation and ongoing monitoring. primary file regulatory fda-euas 2020-12-01_CDC EUA IFU - CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.md regulatory/fda-euas/2020-12-01_CDC EUA IFU - CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.md 2020_12_01 docx docx Public Domain 27009 44009 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