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by soared 2302 days ago
> This is a tough one. I'm an attending physician.

> Guidelines are there for a reason. As much as I despise our Commander in Chief, I don't think the CDC is compromised. Fear doesn't rank over guidelines, but I understand the situation. No one wants to be the doctor that discharges patient zero.

> Personally, I'd admit you for fever of unknown origin for the time being and monitor you for any signs of sepsis. If everything looks good from an observation stand point, I'd discharge you with strict droplet precautions until the fever subsides.

> I think your doctor did the right thing given the context.

Given the above comment, most replies here are arguing against CDC regulation saying it is too stringent. Its very helpful to understand comments in this lens, rather than that the CDC is just under-testing for unknown reasons.

4 comments

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.
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.
Apparently some kits were recalled because they were flawed and there is a shortage as a result. So it is somewhat understandable that the CDC doesn't want to test just anyone with flu like symptoms.
During flu season.

That line is always left out of this: the CDC doesn’t want to test just anyone with cold and flu symptoms ... during flu season.

The false positives are basically guaranteed to absolutely swamp the true positives at this time, and demolish any attempt to target the sick.

They are supposed to only test people with flu like symptoms that test negative for flu. Which this person did.
Still, the test specificity (or more generally, its predictive power) is likely to be quite low simply due to the sheer number of flu cases.

Otoh, this doesn’t really explain why there would be regulations against developing in-lab tests (as another of the sibling comments mentions).

Shit-tons of people with the flu test negative for flu. It’s not a very sensitive test.
the CDC doesn’t want to test just anyone with cold and flu symptoms ... during flu season.

This wasn't just "anyone" though. But someone who tested negative for the usual suspects -- and just came back from a high-risk country.

I keep hearing rumblings about test kits not being where they need to be, but nothing in the news. It would be so hard to make a clinical diagnosis of COVID-19 when the chief complaints are "Fever, cough, shortness of breath". Is that the common cold or is this SARS-CoV-2? Giving a massive diagnosis like and being wrong is bad.
With these kinds of things it's always better to error in the direction of caution. Controlling which way you fail is extremely important. You have to know your modes of failure