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Comment by vikramkr | Hacker News Reader

This is an emergency use authorization, not a full approval by the FDA, and this only lasts until the state of emergency ends or the test is actually approved/rejected by the FDA. Either way, this is some exciting news as it could make sample collection easier for testing. It doesn't look like it overcomes the qPCR reagent bottlenecks to actually analyze the samples though, so I wonder what the full impact on testing will actually be.

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So far as I know, all covid tests in use right now are being produced under emergency authorization.

And that's come with a lot of problems as we saw with the antibody testing fiasco with all the nonfunctional tests. So the precedent suggests cautious optimism, emphasis on the cautious.

Actually, emphasis on the optimism. The Yale work is really well done. Sensitivity is a little low, but people keep ignoring cost, scalability, frequency and ease. This is what is needed for back to work/school applications and the first test that actually satisfies these criteria imo.

Absolutely really good work. My concern is still that it doesn't seem to solve the qpcr bottleneck. Its great that it gets rid of ena extraction (as someone trying to get enough reagents to do any sort of real work in my lab - I'm all too aware of how much trouble they're saving themselves by cutting out that bit). The pcr part doesn't seem to be addressed though - amd if it isn't (without something like pooling or using something like LAMP) this will just add to the backlog of tests.

On the other hand, will still def second you on the quality of the work. It's some really solid science.

Main problem was that FDA set too high of a target for tests compared to PCR, iirc it was around 80%, where did they get that number is unknown. There were companies that had rapid antigen tests created back in February (fx E25Bio) which had lower sensitivity, so they were spending all that time to reach the goal, while also forced to make test more expensive. And main problem with that FDA mindset is that accuracy is not random, it depends on amount of viruses in the person and for people who were transmitting the decease accuracy approached 100%, and that's what we care about from the pandemic standpoint.

There's a video from MedCram where co-founder of pharmacy company talks about it in more detail: https://www.youtube.com/watch?v=qKM4MIrfr4k

Tests can be properly regulated and checked by FDA, but if they set target with more thought behind it and acted quickly back in February and we had cheap 15 minutes tests, we wouldn't be in current situation now.

Isn't it still a problem if someone takes a test on day N and it comes back negative, but their viral load increases over the next few days and they begin spreading the virus on day N+3? Many people in such a situation would read the test as "I'm in the clear for a while" and might engage in close contact with friends and family members that would put them at risk.

To be clear, the problem with the antibody testing was that they were not monitored under the EUA until around April. Instead, manufacturers were permitted to market their tests without FDA review, provided that they told customers that the tests had not been reviewed.

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