As a wave of at-home tests for coronavirus are coming on the market, federal regulators issued stern guidance saying that none of them has yet been approved for use and warning consumers to be wary of “unauthorized fraudulent test kits.”
Hours after STAT reported on Friday that at least four startups would roll out at-home tests over the next week, the Food and Drug Administration released a statement saying: “We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for Covid-19.”
Experts told STAT that the new tests may not meet the FDA’s high standards for traditional approval and that consumers risk not getting an accurate result if they don’t swab deep enough in their nose or throat. But the companies defend the at-home tests and insist they are permitted under government rules loosened to expand desperately needed testing for Covid-19, the disease caused by the new coronavirus.
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It would be fantastic to get at-home testing in the market (yesterday!), but there has to be some oversight of “blessing” that any test being used actually meets accuracy standards. The worst thing would be to have multitudes of at-home kit providers putting out their own self-validated tests that are wrong and can’t be trusted. Like it or not, FDA is the entity to validate. Let’s hope they do so quickly!
Who cares about the FDA’s standard of scientific certainty? We have a massive shortage of tents, perhaps in part due to unnecessary red tape. The market is addressing the shortage. Hurray. If they’re ineffective, we’ll know soon enough.
I’ve paid for a test and I don’t care even a little about these warnings.
The FDA is a corrupt cesspool. One of my exes worked at a lab at UCLA and had to to regularly deal with them. She was always complaining how they would constantly get involved in the trials and what not and how a lot of results of studies never see the light of day.
I think there is a totally different reason that we are having issues with testing for Covid 19. Political optics.
The Scam Scavengers are starting their dirty deeds. People are trying to horde Hydrochloriquine, Chloroquine and Quinine Water just like they have hogged and horded masks, gloves, isopropanol, hydrogen peroxide and T paper.
Yes! Let’s not destroy the world over this! Most people affected have few symptoms and recover completely. It makes me wonder if the majority of people dying with this were dying anyway.
I think if there are legitimate at home tests available that do perform as indicated in detection of this new virus, they should be allowed. They should also still have to comply with reports to CDC and whomever else is required at this time. If we want to get ahead of this thing, we have to have the tools to ACTUALLY get ahead of it. Right now we do not even have enough proper testing that has been FDA approved. If this limits possible exposure in clinical settings for mild cases and eases the public’s frantic panic then what is the issue. This isn’t a government how do we make the most money off this time, it’s a let’s all get out heads together, get it wrapped around this thing, and beat the damn curve time. Without gauging the eyeballs or pockets out of the American people or the world for that matter.
If the FDA can validate the test picks up the coronavirus then for the time being for Gods sake let them distribute them…
Agreed!
I agree. In a time when even those with symptoms are being turned away from the usual testing, home tests are a MUST!! I just wish they weren’t so expensive.