Update to COVID-19 Molecular Diagnostics Specimen Requirements

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The US Food and Drug Administration (FDA) now requires real patient samples for COVID-19 molecular diagnostic test validations. The object is not to slow the process of developing new tests, but to increase test quality over time.

The US Food and Drug Administration (FDA) updated its Emergency Use Authorization (EUA) templates May 13, 2020, to require the use of actual positive specimens during validation when applying for EUAs. Previously, assay manufacturers had been permitted to use contrived samples during the validation process due to the unavailability of real patient samples. 

As the number of COVID-19 cases in the United States has increased, the availability of real COVID-19 positive specimens has also increased. “Now that there are positive patient samples, we are shifting from use of contrived samples to supplement applications to the recommendation that actual patient samples are used for the clinical performance testing,” Timothy Stenzel, MD, PhD, Director of the FDA’s Office of In Vitro Diagnostics and Radiological Health said.

This change was discussed during the May 13 FDA town hall and has been reflected in updated EUA templates provided on the FDA’s website. Some of the considerations addressed were:

  • Real patient samples should now be used in validating COVID-19 molecular diagnostic assays for EUA applications.
  • Manufacturers with pending EUA applications should discuss these changes with their assigned reviewers.
  • The FDA’s approach to pending applications will be to “be reasonable, but make the transition as expediently as possible.” For example, the agency may ask that manufacturers perform additional post-market analysis if a submission has already been prepared using contrived samples.
  • The FDA may not apply a strict standard in cases where it is extremely difficult for developers to obtain real patient samples.
  • The FDA intends not to slow the process of developing new tests, but to increase test quality over time.

Related Resources:

Updated FDA EAU Templates

FDA Now Requiring Real Patient Samples for COVID-19 Molecular Diagnostic Test Validation

List of All Current EUAs

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