FDA Requires Real Patient Samples for Emergency Use Authorization of COVID-19 MDx Tests

The US Food and Drug Administration (FDA) now requires molecular diagnostic developers to use actual positive specimens as part of its validation process for granting Emergency Use Authorization (EUA) to COVID-19 tests.

Manufacturers of assays had so far been permitted to use contrived patient samples for their EUA submissions. However, the FDA has now updated its requirements for developers seeking EUA for COVID-19 tests and use actual positive specimens as part of the validation process.


According to the FDA’s updated requirements which have been incorporated in its molecular diagnostic template for developers, a minimum of 30 positive prospective, retrospective, or leftover patient samples should be evaluated, while frozen samples are acceptable. The results must be compared to a high-sensitivity EUA RT-PCR assay, which uses a chemical lysis step, followed by solid phase extraction of nucleic acid.

"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," said Timothy Stenzel, director of the FDA’s office of in vitro diagnostics and radiological health. "As a result, for molecular tests the recommendation is to make comparisons to previously authorized molecular tests in order to assess whether or not accurate performance has been established."