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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:
  1. If the laboratory is using a CDC-developed Emergency Use Authorization (EUA) assay, the instructions provided with the procedure must be followed.  
  2. 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After the emergency is resolved and the EUA's are rescinded, laboratories must validate methods as required for the complexity of testing.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   If the EUA's are rescinded and the FDA has not assigned a complexity to the method, laboratories must validate the method as a high complexity laboratory developed test.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 Information for Laboratories: 2019-nCoV
• CDC 2019 Novel Coronavirus
• FDA  Emergency Use Authorizations
• CDC  Clinical Laboratory Improvement Amendments

Coronavirus (COVID-19) Guidance and Resources

Last updated on July 26, 2021
Manual: Laboratory
Chapter: Quality System Assessment for Nonwaived Testing QSA

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