FDA authorizes first Covid-19 test for self-testing at home

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&#x27;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>&quot;In compliance with the strict guidelines of the Food and Drug Administration (FDA)&quot;</i>[1]. So, not exactly FDA approved I guess...<p>[1] <i>&quot;In Übereinstimmung mit den strengen Richtlinien der Food and Drug Administration (FDA)&quot;</i><p><a href="https:&#x2F;&#x2F;www.centogene.com&#x2F;covid-19&#x2F;test-fuer-zuhause-kaufen.html" rel="nofollow">https:&#x2F;&#x2F;www.centogene.com&#x2F;covid-19&#x2F;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.

I cannot find the specificity and sensitivity numbers anywhere. Are they not published?

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:&#x2F;&#x2F;www.lucirahealth.com&#x2F;#the-test-kit" rel="nofollow">https:&#x2F;&#x2F;www.lucirahealth.com&#x2F;#the-test-kit</a>

IFU has a lot more information: <a href="https:&#x2F;&#x2F;www.fda.gov&#x2F;media&#x2F;143808&#x2F;download" rel="nofollow">https:&#x2F;&#x2F;www.fda.gov&#x2F;media&#x2F;143808&#x2F;download</a>

Here is the actual approval letter: <a href="https:&#x2F;&#x2F;www.fda.gov&#x2F;media&#x2F;143810&#x2F;download" rel="nofollow">https:&#x2F;&#x2F;www.fda.gov&#x2F;media&#x2F;143810&#x2F;download</a><p>I can&#x27;t find anything in it that says the FDA actually tested this, nor do I find any claims of accuracy in it.

Don’t see anyone mention this here but it’s worth noting this company is a YC company