[0] https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html
[1] https://www.gov.uk/guidance/coronavirus-covid-19-information...
[0] https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html
[1] https://www.gov.uk/guidance/coronavirus-covid-19-information...
Local labs could develop or purchase their own test kits, but during an a public health emergency, they must get FDA authorization before launching such a test.[1]
This seems to me like a giant institutional and bureaucratic screw up.
Hopefully the FDA may be finally getting its act together and fast-tracking approval of local tests: https://twitter.com/ScottGottliebMD/status/12330216819181936...
[0] https://www.politico.com/news/2020/02/20/cdc-coronavirus-116...
[1] https://threadreaderapp.com/thread/1231944326827081729.html
Edit: Oh hey they did publish an RT-PCR protocol [1] plus sequences, [2] along with a disclaimer not to use them directly on human subjects. This is just silly (IMO).
> These procedures and/or reagents derived thereof are intended to be used for the purposes of respiratory virus surveillance and research. The procedures and reagents derived thereof may not be used directly in human subjects.
[1] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detecti...
[2] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-p...
Without review, unscrupulous (or incompetent) vendors could make a test with unknown usefulness.
https://en.wikipedia.org/wiki/Type_I_and_type_II_errors
Medical testing is very, very murky. There was a time a routine medical test for me came back, indicating I possibly had Lupus. It turns out; this test has a false positive rate of about 5%.
I am a white male, and the rate for lupus for my group is astronomically low. The rate for the worst group (black females) is like 500 in 100,000. There's some evidence the rate around white males might be six times lower.
Had I known any of this at the time, or had my doctor explained it, I wouldn't have spent weeks worrying.
The fact is, medical tests just update the probability you're sick or well. And this is why they have to be well understood.
I said no to the doctor, and had them do another test, which said I was just fine.
Where are you getting this crazy idea? Have you ever known anyone who took it? I have two relatives (not biological) on synthroid and even small changes in doses have massive effects on their metabolism, tiredness, etc. Taking thyroid hormone when you don't need it is not harmless, just like any drug or hormone.
but they neglected conditional probability. so many people were being tested that the probability they had HIV was much lower than 98%. they changed the letters to say "inconclusive" instead of "positive" and had them take the test again, which reduced the needless suicides.
Normally they can be done without approval, but there is a special regulation on the books that activates when the department of health and human services declares a public health emergency.
Remember this folks when voting for people who advocate for a greater role of bureaucratic control of our lives.
The good comes with the bad. There is a lot of nuance that such blanket statements generally don't capture.
Because large bureaucracies only ever get modified in the aggregate.
You have a bureaucracy that imposes 500,000 rules. If you want to know which are worth it, you have to evaluate each of the rules individually, because some may be worth it and others not.
Really evaluating 500,000 separate rules would take a large staff multiple lifetimes, so you still have to decide whether the bureaucracy as a whole is doing net good or net harm in order to determine whether it should be suspended for the years it will take to evaluate all the rules.
But by the time you finish the evaluation, years have passed since you started and the facts on the ground may have changed, or new rules proposed, so the evaluations are stale before they're completed and you have to start over.
It leaves you with only the systemic question of whether large bureaucracies are a net positive force as an institution. The answer could reasonably be no.
But notice that the answer is also related to the size. Because if the bureaucracy is smaller, you can finish the evaluation sooner, possibly soon enough that the evaluation results are still relevant by the time you finish. Having fewer rules allows you to have better rules, because the fewer you have the more time and other resources you have to make sure each is doing more good than harm.
I would agree it is impossible to prevent all potential misunderstanding when writing for a large audience, but various methods can make this kind of misunderstanding less likely:
- Emphasize qualifiers like "some", "most", "often", "sometimes", "not all", "many", etc.
- Anticipate and explicitly disclaim possible misinterpretations
- Acknowledge valid counter arguments
- Be very precise and explicit about our intended mentioning
Remember this folks when voting for people who advocate for privatizing or de-regulating industries.
- Google: 100,000
- Procter and Gamble: 100,000
- GlaxoSmithKline: 100,000
(Weird how the figures for the first three random companies I looked up are so close...)
- Health and Human Services: 80,000
- Uber: 20,000
- FDA: 15,000
- Sanofi Pasteur (working on coronavirus vaccine): 15,000
- CDC: 10,000
Corporate bureaucracies can absolutely be just as terrible. But the problem isn't that a bureaucracy exists, it's that there is a law requiring the approval of a specific bureaucracy.
If a corporate bureaucracy is slow and inefficient, that sucks, but it creates an opportunity for somebody else to be less slow and less inefficient. If a government bureaucracy is slow and inefficient, can you start your own and go into competition with them?
doing that without proper training equipment and expertise should be discouraged, even if it isnt the original intent of the restriction it does seem to reduce a possible avenue of amplification of the problem
The CDC has actually issued official guidance regarding Coronavirus biosafety. [1] Other than discouraging unnecessary culturing of the virus, BSL-2 (a fairly common setup) is the main recommendation.
[1] https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs...
this is because if you truly understand the materials present in the assay kit, you can, with a well stocked genetics laboratory, begin recombinant proceedures
you could create an mRNA and arrange the proper signaling and delivery [hopefully] and do something very risky like try to biohack an adaptive immune response into a vaccination
thus the disclaimer ~ dont put it in people
there is a form if you want to see about trying to help out:
if you want to request the RT/PCR kit:
[1] https://www.internationalreagentresource.org/About/IRR.aspx
If you think you have a good idea and want to help:
[2] https://medicalcountermeasures.gov/app/barda/coronavirus.asp...
It's quite possible I've missed some crucial piece of information about why this wouldn't work. So far though, I've seen no reasonable explanation as to why we need specially approved kits at this point. These are standard reagents and standard techniques; the lack of widespread rapid testing in the US is bureaucratic in nature, not technical.
that is the thing right there-
the federal government has OCD when it comes to a lot of things its not that you dont have a reputation as a professional, its that you/we dont have a rep with them until they check us out.
+ if you want a kit use form [1]
if you think the kit is somehow deficient goto form [2]
that is the way federal government engages.
there are structural conformations that are not indicated-
you must exploit a biological system that will create a functional virion-
before you do that , if you understand genodynamics of the sequence you can start making good guesses about where to change the sequence in what way-
this can be because you want attenuation of the virus with an extreme degree of control-
this is how you make a recombinant product that is not as damaging to the host and produces a strong antigenic signal to the immune system this means you have a vaccine-
of course this is also a dualpotential technology so it could be used for evil and weaponized, so we want to have some inspection regarding who has these opportunities
To be perfectly clear:
* The CDC has already made an RT-PCR protocol plus associated primer and probe sequences publicly available.
* BSL-2 labs that do cell culture and employ viral vectors for transfection [1] are quite common in academia.
[1] https://www.thermofisher.com/us/en/home/references/gibco-cel...
To make sure it's a reliable test with known error bars to avoid false positives and negatives. If your data is garbage who cares how quickly you get it?
"Outbreak" and "Contagion" both depict mass outbreaks of deadly viruses, and the social impacts of implementing last-ditch control efforts. There's a certain point where panic about an epidemic is more damaging than the epidemic itself, and I worry we're approaching that point with coronavirus. When everybody is freaking out is exactly when we need to enforce good public health practice, not throw it by the wayside and go full wild west.
why should a non-invasive diagnostic test require any sort of approval?
Because false negatives are worse than no test at all / unknown.And thus, how we find it now is bursting clusters with illnesses that can't be hidden by "flu." By then it's too late.
Seems like the only way to contain it is do blanket nationwide testing every day and quickly contain anyone who tests positive, for like 6 months.
There's no reason to test when there isn't a high confidence that the person has the virus. Especially when the test costs something north of $3,000 and even with good insurance only a fraction of it is being paid for based on numerous Reddit threads and a news article [0] puts a specific patient's bill at:
>$3,270 two weeks after his test. He will be responsible for $1,400 of that bill.
A Forbes article [1] two weeks ago even states:
>The cost of testing include the costs of test kits, labor, and sample processing. In some cases, storage and delivery costs would need to be added. It’s unclear what the costs of the test kits are, or ancillary items, as CDC and others haven’t revealed figures. For the sake of argument, let’s say that on the low end of the scale each test, including ancillary items such as labor and sample processing, costs $250, and at the high end it’s $1,500.
[0] - https://www.independent.co.uk/news/world/americas/coronaviru...
[1] - https://www.forbes.com/sites/joshuacohen/2020/02/12/testing-...
It's also critically important to act quickly, as it's at the early stages when this outbreak has a chance to be stopped. If we keep waiting until it's obvious that there's a large outbreak in the US it may be way too late.
You don't have to test everyone in the US, or even anyone who has a cough, but everyone with severe symptoms of the disease should have been tested, regardless of whether they've recently been to China or had contacts with people who had.
"Oh heavens no, we can't afford to preventatively test for a virulent new lethal pathogen that has already brought one of the world's largest economies to a total standstill - it costs literally dozens of dollars!"
The country gains from the results, but isn't offering to pay.
If I had been to China and got ill when returning to the US, I would not be getting tested - the test wouldn't help my chance of survival, and would just cost me money and time.
The patient who is tested negative gets their life back, and can stop self isolating immediately.
The self isolation protocol is pretty intense.
https://www.gov.uk/government/publications/wuhan-novel-coron...
Maybe you could get a backlog going that can test for COVID-19, when the lab's RT-PCR machines are underutilized, even after the patient leaves, so that we can get as much data as we can.
I am curious to know more about the actual process.
See https://towardsdatascience.com/statistics-and-unreliable-tes... for an analysis using Bayesian statistics that demonstrates why you would pre-filter who you give the test to, and why you shouldn't necessarily trust the test results after.
Please remember that public health organizations have over 150 years of experience with how to make the most effective use of existing resources to limit health challenges. This is a complicated optimization problem and the people doing it aren't stupid. It is better to ask why they do what they do than to assume that what they are doing makes no sense.
That doesn't sound right to me (i.e. only the case if false positive distributions are independent and uncorrelated, which seems unlikely), but I don't know enough about statistics and epidemiology to dispute it.
Take your pick.
Administration officials just refused to commit to making a tax payer funded vaccine affordable.
This is what end game capitalism in health care looks like.