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 COVID19 diagnostic tests .
The COVID 19 tests can 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 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.”
He emphasized that these types of tests will be a game-changer in the 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.