Understanding, verifying and implementing Emergency Use Authorization molecular diagnostics for the detection of SARS-CoV-2 RNA

This new paper from the American Society for Microbiology Clinical and Public Health Microbiology Committee is US-focused but maybe of interest to others.

It is aimed at microbiological laboratories that can usually develop and validate LDTs under Clinical Laboratory Improvement Amendments (CLIA) but in a Public Health Emergency they have to apply for Emergency Use Authorisation unless they use an assay that already has EUA.

The paper describes exactly that: how to validate a “non-modified commercial EUA test” and points to the FDA EUA guidance for labs that make modifications:
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd

In general, it is a good run-through of various considerations for lab testing.

Jenny

1 Like