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by voidmain 2304 days ago
The guidelines for testing were so absurdly stringent because there was almost no testing capacity in the US, despite their being hundreds of labs with RTPCR equipment, because the CDC screwed up their test kits and the FDA used emergency powers to prohibit labs from developing their own tests, and forbids the creation of commercial test kits and the importation of foreign ones. Three weeks after CDC (after an already unconscionable delay) shipped the non working tests, they have "fixed" this situation by permitting labs to use the 2 of the 3 primers in the original test that mostly work. So as of yesterday we are starting to have the ability to actually test, and the criteria are being loosened.
2 comments

Details from sciencemag.org (A magazine from the American academy for the advancement of science):

https://www.sciencemag.org/news/2020/02/united-states-badly-...

>Well-equipped state or local labs can use these—or come up with their own—to produce what are known as a “laboratory-developed tests” for in-house use. But at the moment, they’re not allowed to do that without FDA approval.

Wow this is frankly insane. Pretty much every biology laboratory in the USA should have the tools available to perform these tests. More than that, RT-PCR is a routine assay that any self-respecting wetlab biologist can do. If they are struggling to produce these kits they should be letting people order their own primers. Even if less reliable, at least then they would be able to test patients properly.

Yeah, I don't understand why it's literally illegal to take a swab and run a PCR against the known, published viral sequence. Forget "any self-respecting wetlab biologist," I'm pretty sure an undergrad with a year's worth of lab experience could run the test, at least under supervision.

Edit: I suppose you do need a "self respecting wetlab biologist" to synthesize the primers, but running the test itself is pretty simple.

Running the test is simple but getting good primers nowadays is easy because they can be bought and arrive 24 hours later. If the sequence is published, then even the lab manager can get them.
Yes, labs don't synthesize their own primers. They buy them from suppliers. The kind of primers you would use for SARs-Cov2 would be about $10-$20AUD (similar for USD) a vial and be sufficient for several hundred reactions (maybe a hundred or so tests with triplicate replicates, pos and negative controls). The thermocycler and the technician doing the pipetting are the expensive bits, not the primers!
>> forbids the creation of commercial test kits and the importation of foreign ones

I was wondering about this... Very hard to justify that in my opinion.

Seems pretty mucked up.