US FDA sets new template for non-lab COVID-19 diagnostic test developers

The US Food and Drug Administration (US FDA) released a new template for commercial developers to help them develop and submit emergency use authorisation (EUA) requests for COVID-19 diagnostic tests to be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

According to FDA Commissioner Stephen M Hahn, “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test. We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available. These types of tests will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”

The template includes recommendations for validation when a sample is to be collected and analysed, and results are to be returned without the need to send a sample to a lab for analysis. The template also gives recommendations for validation of tests that are intended to be made available over-the-counter, that is, without a prescription.

According to a release, the template outlines the recommended performance for this type of test, including sensitivity and specificity. While the recommended sensitivity for these non-lab tests is lower than lab-based tests, the tremendous benefits of broader access to simple and fast testing options generally outweigh this risk.