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 outweighs this risk. This template outlines the recommended performance for this type of test, including sensitivity and specificity. The template also gives recommendations for validation of tests that are intended to be made available over-the-counter, that is, without a prescription. The template includes recommendations for validation when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a lab for analysis. 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.” 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. “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. “The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that 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.
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