Paper - Blommel - Authorized SARS-CoV-2 molecular methods show wide variability in the limit of detection A 2022 study analyzing the limit of detection (LoD) of 247 SARS-CoV-2 molecular diagnostic tests that received FDA Emergency Use Authorization, finding wide variability in reported sensitivities and a statistically significant discrepancy between LoD values reported in EUA documentation versus the FDA reference panel, with 40% of reference panel-tested devices unable to detect virus at levels one standard deviation below mean first-test viral load. primary file regulatory fda-policy 2022-12-15_Paper - Blommel - Authorized SARS-CoV-2 molecular methods show wide variability in the limit of detection.md regulatory/fda-policy/2022-12-15_Paper - Blommel - Authorized SARS-CoV-2 molecular methods show wide variability in the limit of detection.md 2022_12_15 Published in Diagnostic Microbiology and Infectious Disease 105 (2023) 115880. DOI: 10.1016/j.diagmicrobio.2022.115880 pdf Elsevier COVID-19 open access - unrestricted research re-use with acknowledgement of original source 4629 7617 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