FDA24 Mar 2021 15:34
New guide lines from the FDA:
New Guidelines from the FDA
Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions, such as whether an individual should participate in an activity, based on the test results.
First, the FDA issued a new supplemental template for test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission. This template applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This includes tests conducted in any location, including in a laboratory, at the point-of-care (POC), or even places such as a person’s home or certain non-traditional sites such as offices, sporting venues, airports, schools, etc.
We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing.