Author: Mitchell, Stephanie L.; St. George, Kirsten; Rhoads, Daniel D.; Butler-Wu, Susan M.; Dharmarha, Vaishali; McNult, Peggy; Miller, Melissa B.
Title: Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA Cord-id: 04zh6hwa Document date: 2020_7_23
ID: 04zh6hwa
Snippet: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought a new wave of challenges to health care, particularly in the area of rapid diagnostic test development and implementation. The diagnosis of acute coronavirus disease 2019 (COVID-19) is critically dependent on the detection of SARS-CoV-2 RNA from clinical specimens (e.g., nasopharyngeal swabs). While laboratory-developed testing for SARS-CoV-2 is an essential component of diagnostic testing for this virus, the m
Document: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought a new wave of challenges to health care, particularly in the area of rapid diagnostic test development and implementation. The diagnosis of acute coronavirus disease 2019 (COVID-19) is critically dependent on the detection of SARS-CoV-2 RNA from clinical specimens (e.g., nasopharyngeal swabs). While laboratory-developed testing for SARS-CoV-2 is an essential component of diagnostic testing for this virus, the majority of clinical microbiology laboratories are dependent on commercially available SARS-CoV-2 molecular assays. In contrast to assays approved or cleared by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use, assays for the detection of SARS-CoV-2 nucleic acids have emergency use authorization (EUA) from the FDA. Outside of highly specialized academic and commercial laboratory settings, clinical microbiology laboratories are likely unfamiliar with the EUA classification, and thus, assay verification can be daunting. Further compounding anxiety for laboratories are major issues with the supply chain that are dramatically affecting the availability of test reagents and requiring laboratories to implement multiple commercial EUA tests. Here, we describe guidance for the verification of assays with EUA for the detection of SARS-CoV-2 nucleic acid from clinical specimens.
Search related documents:
Co phrase search for related documents- academic medical center and acid amplification test: 1
- academic medical center and acid test result: 1
- academic medical center and acute case: 1, 2
- academic medical center and additional ppe: 1
- academic medical center and additional risk: 1, 2, 3
- academic medical center and additional testing: 1, 2
- academic medical center and additional training: 1, 2
- academic medical center and low positive: 1, 2
- acceptable consider and accuracy study: 1
Co phrase search for related documents, hyperlinks ordered by date