Practical Guide to Verifying EUA Molecular Assays for SARS-CoV-2 Detection
This guidance article addresses the practical challenges clinical microbiology laboratories faced when implementing Emergency Use Authorization (EUA) molecular tests for SARS-CoV-2, a regulatory pathway unfamiliar to most labs. The authors provide a verification framework for EUA assays, which is especially relevant given supply chain disruptions that forced laboratories to validate multiple commercial platforms simultaneously. The paper became an essential reference during the pandemic testing scale-up.
The original study
Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA.
- Authors
- Mitchell SL, St George K, Rhoads DD, Butler-Wu SM, Dharmarha V, McNult P, et al.
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Review
- PMID
- 32381642
Original abstract
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.