FDA releases model for COVID-19 home testing

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United States Food and Drug Administration (FDA) released a new model for clinical test developers, designed to help these companies develop and submit an Emergency Use Authorization (EUA) for COVID-19 tests that can be performed at home or in settings other than laboratories. In addition, these tests could be sold without a prescription.

FDA Commissioner Stephen Hahn said, “These types of tests will be a game-changer in our fight against COVID-19 and will be crucial as the country considers reopening. “

To date, the FDA has not authorized the sale of COVID-19 home tests. Lab tests are generally accurate, but often only used for people with actual symptoms of COVID-19. And it can take several days to get results, which means infected people could infect people in the meantime.

There are quick tests, but they tend to be expensive. For example, USA today Note that a Massachusetts clinic charges $ 160 per rapid test that is not covered by insurance.

The theory is that by being able to test for the disease at home, perhaps once or twice a week, people would be more likely to self-quarantine before going to work, school, attending school. an event, to visit an older person or to travel by plane, bus or other type of public transport.

Dan Larremore, assistant professor of computer science at the BioFrontiers Institute at the University of Colorado Boulder, whose work focuses on, among other things, genetic epidemiology and the evolutionary history of the disease, said USA today that the FDA’s decision was a step in the right direction and could encourage companies to develop rapid and inexpensive home tests.

However, Michael Mina, an infectious disease epidemiologist at Harvard TH Chan School of Public Health, suggested that the FDA’s model is so complicated that these tests may never be made public.

“The [required] software alone will be an incredibly big hurdle for many, ”said Mina USA today. “Unfortunately, the model does not offer that kind of ‘new’ avenue which I believe will be necessary if we are to make the daily $ 1 testing a reality.”

The model, writes the FDA, “includes recommendations for validation when a sample is to be collected and analyzed, and the results must be returned without the need to send a sample to a lab for analysis.” The model also gives recommendations for the validation of tests intended to be available over the counter, that is, without a prescription.

Of course, the FDA model specifies the requirements for sensitivity and specificity, noting that while the sensitivity of non-laboratory tests is lower than that of laboratory tests, “the enormous benefits of broader access to quick and easy testing options usually outweigh this risk ”.

Mina actually suggests that the standards be lowered even further, as contagious individuals are only truly contagious when their virus levels are extremely high, meaning they can be detected with a less sensitive test.

Other rapid home tests, such as those used to diagnose strep throat, have a false negative rate of around 20%, notes Emily Volk, president-elect of the College of American Pathologists. As a result, doctors usually send a throat culture to a lab for confirmation. Confirmation usually takes a few days. But, she notes, if that were the case with home COVID-19 testing, it would add delays to traditional testing instead of relieving them.

There are a few COVID-19 tests that may soon hit the market that are quick and relatively inexpensive, but none have met the goal of costing $ 1 and providing a response within minutes.

XPRIZE, a non-profit association which develops and organizes public competitions, announced earlier this week, he would share a $ 5 million prize with five winners who can create a test that gives results in at least 15 minutes and costs less than $ 15. Additionally, the winners will split $ 50 million for rapid manufacturing scale-up, said Jeff Huber, president and co-founder of OpenCovidScreen, a company that collaborates with XPRIZE on the competition.

The competition is open until the end of August. Around 200 semi-finalists will be chosen, reduced to 20 finalists, then five winners.


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