FDA clears rapid at-home Covid-19 tests without a prescription

Several over-the-counter Covid-19 tests were cleared Thursday by the Food and Drug Administration for use without a prescription, providing a way for schools, workplaces and other groups to screen quickly.

So-called antigen tests offer faster results with less lab work and can be used to quickly and frequently test people for catching, especially those who are asymptomatic and at risk of unknowingly spreading the virus. .

Rapid antigenic tests will be particularly useful for serial testing, which involves “testing the same individual several times in a few days, and may increase the chances of detecting an asymptomatic infection that might not always appear with a single test,” according to the FDA.

The newly authorized diagnostic tests, which require users to collect a sample with a nasal swab, could help schools, workplaces, communities and other groups set up serial testing programs, said the FDA.

The FDA clearance covers Quidel’s QuickVue At-Home OTC Covid-19 test and several versions of the Abbott BinaxNOW tests, including those designed to be taken at home and one that can be used in healthcare settings, like a doctor’s office. , without a prescription.

A separate point-of-care test developed by medical technology company BD has also been cleared by the FDA for serial screening with a prescription.

Rapid antigen testing will be an important tool for public health officials to track how the virus is spreading and changing as the country opens up and life returns to normal.

“Frequent rapid testing will be important in the months and years to come, as we will know more about the duration of vaccine immunity and the course of the variants,” Dr Michael Mina, assistant professor of epidemiology at the TH Chan School of Public Health said in a statement.

Antigen tests are designed to detect fragments of viral proteins that trigger an immune response in the body. These tests are not as sensitive as the polymerase chain reaction or PCR tests, which have been the main screening method for Covid-19. As such, it is possible for antigen testing to provide false negative results, which makes frequent testing even more important.

“We know that frequent testing with rapid results is essential because anyone can be exposed to this virus and not realize it until after becoming infectious,” Mina said in the statement. “The best way to fight the spread is to give people the tools to know they are contagious in real time.”