Finally. Medical experts have been wanting this for a while. Dr. Michael Mina was the first to get my attention on how important at-home-tests could be in curbing covid-19. I just wonder why it took them so long? How bad could the side effects be for a test that is a couple of percentage worse than PCR? I think the FDA was too conservative on their timeline for this when we think of how many people are dying today. I also think the FDA is being too conservative on approving the mRNA vaccines, but that is another can of worms.
I did an at home self-test in summer. I believe it was advertised as FDA approved. Now I'm not sure if it was FDA approved at all or FDA approved but not for self-testing at home.<p>EDIT:<p>I looked it up, it says: <i>"In compliance with the strict guidelines of the Food and Drug Administration (FDA)"</i>[1].
So, not exactly FDA approved I guess...<p>[1]
<i>"In Übereinstimmung mit den strengen Richtlinien der Food and Drug Administration (FDA)"</i><p><a href="https://www.centogene.com/covid-19/test-fuer-zuhause-kaufen.html" rel="nofollow">https://www.centogene.com/covid-19/test-fuer-zuhause-kaufen....</a>
Compared to tools like contact tracing, this could be a tangible tool for the general population.<p>Problem is still availability, but it is great news that we might get something like this.<p>Even if you have a false positive, people can monitor their health or do another test. False negatives are a problem, but it would still be better than the current situation, so I think there are only advantages.
The <i>Lucira COVID-19 All-In-One Test Kit</i> [1] is a disposable electronic test kit powered by two AA batteries. This is not a Michael Mina $dollar-a-day lick-a-stick that is sensitive to infectious viral loads (PCR CT of 24 or less).<p>This device is sensitive to equivalent CT values of 37.5 or less coming close to PCR which score viral loads as low as CT of 39 as positive.<p>Regulators have set the bar too high. We need cheap and easy daily rapid tests that are sensitive to infectious viral loads.<p>[1] <a href="https://www.lucirahealth.com/#the-test-kit" rel="nofollow">https://www.lucirahealth.com/#the-test-kit</a>
IFU has a lot more information: <a href="https://www.fda.gov/media/143808/download" rel="nofollow">https://www.fda.gov/media/143808/download</a>
Here is the actual approval letter: <a href="https://www.fda.gov/media/143810/download" rel="nofollow">https://www.fda.gov/media/143810/download</a><p>I can't find anything in it that says the FDA actually tested this, nor do I find any claims of accuracy in it.