In this segment of Health Minute, the FDA now requires antibody test makers to submit emergency authorization requests along with proof that the tests work within 10 days.
Mandy Gaither reports.
Tests have flooded the market.
Mandy gaither has more in today's health minute.
:00-:23 :23-:42 :53-:58 :58-1:04 1:08-1:12 the f-d-a will now require antibody test makers to submit emergency authorization requests -- along with proof the tests work -- within 10 days.
The agency is also setting specific performance recommendations for all test developers -- saying they will work with the national cancer institute to independently validate antibody tests on the market.
Antibody tests are used to check for prior covid-19 infection and can provide a better sense of how much of the population has already been infected and might have some immunity to the virus.
It's still not clear whether the presence of antibodies means someone is immune or how long that immunity might last.
In mid-march -- the f-d-a loosened approval standards in an effort to get antibody tests on the market -- but -- it quickly became clear that many of those tests were unreliable -- a number of tests had high rates of false positives -- which could give people a false security by leading them to believe they've already been infected and have immunity from the virus.
The f-d-a hopes by validating antibody tests -- the agency will have better data to decide whether to authorize the test -- work with the test developer to sort out
Gov. Wolf says the state is making progress in the fight against COVID-19.
In today's health headlines we talk about more oversight for companies selling antibody tests. There is a Llama from Belgium that..