COVID-19 - Validation of COVID-19 Test
My laboratory wants to begin testing for COVID-19, what is required for validation of this test?
Any examples are for illustrative purposes only.
Laboratories who elect to conduct COVID-19 testing must follow the guidance released by the FDA, CDC, and CLIA (CMS). Since this is an emergent and changing situation, it's best to review those websites often. The FDA is allowing for an abbreviated validation process, but laboratories must follow those FDA guidelines. The manufacturer should also be able provide additional information.
The Joint Commission is following the guidance from FDA, CDC, and CLIA (CMS) as follows:
Additional Resources
CDC 2019 Novel Coronavirus Laboratory Biosafety
CDC 2019 Novel Coronavirus
FDA Emergency Use Authorizations
CDC Clinical Laboratory Improvement Amendments
Laboratories who elect to conduct COVID-19 testing must follow the guidance released by the FDA, CDC, and CLIA (CMS). Since this is an emergent and changing situation, it's best to review those websites often. The FDA is allowing for an abbreviated validation process, but laboratories must follow those FDA guidelines. The manufacturer should also be able provide additional information.
The Joint Commission is following the guidance from FDA, CDC, and CLIA (CMS) as follows:
- If the laboratory is using a CDC-developed Emergency Use Authorization (EUA) assay, the instructions provided with the procedure must be followed.
- If the laboratory is using an Emergency Use Authorization (EUA) assay not developed by CDC but approved by the FDA, the laboratory director must determine the number of positive and negative specimens needed to verify performance and must follow manufacturer's instructions.
After the emergency is resolved and the EUA's are rescinded, laboratories must validate methods as required for the complexity of testing. (Joint Commission standard QSA.02.01.01 EP 1 for moderate complexity and EP 2 for high complexity.) If the EUA's are rescinded and the FDA has not assigned a complexity to the method, laboratories must validate the method as a high complexity laboratory developed test. (Joint Commission Standard QSA.02.01.01 EP 2.)
Additional Resources
CDC 2019 Novel Coronavirus Laboratory Biosafety
CDC 2019 Novel Coronavirus
FDA Emergency Use Authorizations
CDC Clinical Laboratory Improvement Amendments
Manual:
Laboratory
Chapter:
Quality System Assessment for Nonwaived Testing QSA
Last reviewed by Standards Interpretation: December 22, 2021
Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: April 03, 2020
This Standards FAQ was first published on this date.
This page was last updated on July 22, 2024
with update notes of: Review only, FAQ is current
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Reflects new or updated requirements: Changes represent new or revised requirements.
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