FDA approves first rapid coronavirus test with 45 minutes detection time

> The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said, without giving details.

So this doen't seem to be some speculative thing. What's different from their other tests is the RNA target. And that's public knowledge. So it's arguably just procedural.

An established manufacturer of lab tests actually has quite a lot of incentive to produce tests that work.

I also wonder how different this approval is in terms of meaningful scrutiny from a normal approval.

my understanding is that Cepheid has 23,000 testing machines. 5,000 of them are in US. The new test cartridge will work on existing machines. [1]

FDA approval is for the specific test, not for the machine itself (as those did not need to change).

I was searching for analogous situation, where these machines were able to accurately detect other infections and it seems that they were able to perform at 100% for flu-A at 100% accuracy. [2]

My impression sofar, is that FDA was definitely asked to work faster and more efficient, but it does not seem like that they had 'cut corners' so to speak, and approved something out of the 'blue'.

[1]https://www.lucianne.com/2020/03/21/rapid_coronavirus_test_a...

[2]https://www.labmedica.com/microbiology/articles/294780980/po...

That's an antibody detection test, not an RNA sequencing test. You need to have had the virus for long enough for your body to have started to produce antibodies against the virus. It's useful for determining whether the cough you had last week was or wasn't coronavirus, but not so good for early detection.

That was the CDC. The FDA doesn't develop tests - their only role here is to ban people from using tests that have been developed.

That was the CDC. The article says the tests were successfully tested in China.

The FDA makes sense as an independent entity that does impartial comprehensive testing, because you need somebody to figure out if something really works who isn't motivated by wanting to sell it to you.

But their role should be advisory. If they run a trial and it shows that a given drug has a given effectiveness and particular side effects, they should publish that information and be done. Then it should be up to you and your doctor whether it's something that makes sense for you.

They shouldn't be in the business of prohibiting stuff -- especially when the only reason they have for prohibiting it is that they haven't gotten around to testing it yet.