Is there any particular reason the US is testing so few people? They've only tested 445 people in the entire country so far[0], which is a tiny number for such a large country (contrast e.g. with the much smaller UK which has tested 7,690 people[1])? Wasn't that one of the lessons from Italy - the numbers of confirmed cases seemed to shoot up from 21 Feb mainly because that's when they started testing.
The test-kit that the CDC sent to local labs had a faulty reagent, so all test requests have to be sent back to the CDC.[0]
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.
In all seriousness, why should a non-invasive diagnostic test require any sort of approval (particularly during an outbreak)? This is just RT-PCR if I understand correctly - there's nothing particularly novel going on here. Just publish the primer sequences and let the biotech industry handle things.
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.
My understanding is that it’s based on a law from several decades ago, when it was difficult to get your hands on a sequencer, that was meant to help empower the CDC once some kind of pandemic was declared in order to get tests out faster. Now that sequencers are commonplace, the same law instead of speeding up the deployment of these tests now slows them down.
>FDA regulates test kits but generally lab developed tests, which are designed and used in single lab, can be offered without FDA review. When HHS declares Public Health Emergency and issues declaration to support EUAs, labs must seek FDA authorization before launching new test.
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.
Because government bureaucracies cease to function in their original task and become only concerned with their preservation. It’s a lesson that happens over and over and we selectively ignore it.
Remember this folks when voting for people who advocate for a greater role of bureaucratic control of our lives.
Taken literally, you are correct and you advocate good advice - to remember this and presumably weigh it among the pros and cons. However, your phrasing could be interpreted to have a subtext suggesting less bureaucracy is always better.
There's no way to criticize any bureaucracy without having a subtext that less bureaucracy is always better, if the mere implication that less bureaucracy would have prevented the problem is enough to conjure that subtext in the minds of the readers.
Why do we always measure burocracy as an "amount" (something of which there can be "less" or "more"). Surely there can be unnecessary, pointless, frustrating, harmful, nerve-wracking acts burocracy which can require more or less time to be performed. But isn't the real measure we should have one about quality of the outcome and balancing that against any effort endured by the populace?
> Why do we always measure burocracy as an "amount" (something of which there can be "less" or "more").
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.
> There's no way to criticize any bureaucracy without having a subtext that less bureaucracy is always better, if the mere implication that less bureaucracy would have prevented the problem is enough to conjure that subtext in the minds of the readers.
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
As opposed to corporate bureaucracies? If you think the free market magically makes everything efficient and free of politics and bureaucracy, try spending some time in a big company.
Remember this folks when voting for people who advocate for privatizing or de-regulating industries.
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?
Well, the result of the diagnostic test could cause harm (panic, unnecessary treatment, people not quarantined when they should be) if it was not accurate enough, but they should probably fast track something given the circumstances.
You know what causes greater panic? An outbreak that only to the attention of the media when corpses start piling up at the hospital, all because an undetected cluster wasn't identified when it was starting.
> In all seriousness, why should a non-invasive diagnostic test require any sort of approval (particularly during an outbreak)?
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?
^^ This is exactly the answer! The positive predictive value of a test changes based on the prevalence of the disease in the population. With rare conditions, you can end up with way more false positives than actual positives, which can cause actual harm to people.
"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.
when you conduct the assay you are handling a known pathogen
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 thing is, you're already dealing with a patient that might be infected and medical testing labs already process potentially infectious samples on a daily basis.
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.
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 had a problem a couple years ago where my test showed that I had hypothyroidism. My doctor wanted to immediately put me on sythetic thyroid hormone to adjust this. The problem is that I'm thin, athletic, and have no other indicators for risk of hypothyroidism.
I said no to the doctor, and had them do another test, which said I was just fine.
The story is not so remarkable: there is no harm from taking synthetic thyroid hormone, and your TSH is monitored while taking it such that I think the mistake would have been discovered later.
>there is no harm from taking synthetic thyroid hormone
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.
there's a particularly sad story about HIV testing, which is told as a cautionary tale to medical students: during the HIV outbreak, the tests had something like a 2% false positive rate. the result letter made the mistake of telling patients there was only a 2% chance the test was wrong. people committed suicide after discovering their test came back positive.
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.
From reports, the Chinese tests have fairly high false negatives, but they’re still deploying them en masse because catching as much as is possible better than not catching anything at all. I’ve seen nothing on false positives.
Yeah at the end of the day it seems by far the best outcome. I'm just thinking there may be some sort of red tape surrounding the liability aspects of that outcome. Like maybe there's a waiver of liability for passing a sick person off as healthy, except it only applies to such and such equipment, etc. I'm just using my imagination here, I have no experience in the medical industry.
If you're using an officially published primer sequence? Possible (due to supplier or user error), but _highly_ unlikely. We're pretty good at molecular biology at this point.
I'm not talking about making an entire test kit, but rather labs with existing RT-PCR abilities (ie the vast majority of molecular biology labs) having the appropriate primers and probes synthesized by the standard (non-clinical) vendors that they order from every day.
>a disclaimer not to use them directly on human subjects. This is just silly (IMO).
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
That... doesn't make any sense. What does the ability to run recombinant procedures (however ill advised doing so might be) have to do with running an assay on a human sample for diagnostic (as opposed to research) purposes?
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.
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
Are you saying that if i had the test for corona, and then a bunch of knowhow and some wizbang machines I could start making the virus? I was always terrible at biology.
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
I think you've misunderstood. The CDC page I linked provides a diagnostic protocol for testing samples for presence of the virus. The disclaimer explicitly forbids using the protocol as a diagnostic test in a medical setting, reminding the reader that it is not approved for such use and is to be used for research purposes only. That's the silly part - industrial biotech oligos are _more_ than reliable enough for human diagnostic testing during an active crisis.
its not about reliability its about being vetted into the process, rather than have a bunch of randos doing things and making a bunch of reporting noise.
there is a form if you want to see about trying to help out:
A bunch of randos? You mean trained lab technicians with extensive experience running RT-PCR assays on a regular basis? You mean biotech vendors that already synthesize ultra high purity custom oligos? https://www.genewiz.com/en/Public/Services/Oligo
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.
>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]
This isn’t true. Containing the spread through mass testing would allow us to more appropriately measure the response and direct resources accordingly. Every epidemiologist I’ve read says the lack of testing is a very concerning in terms of our ability to address and respond to the pandemic.
>There's no reason to test if there aren't any confirmed cases.
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.
You have to balance that cost against the cost of not containing this outbreak, which is likely to be far, far more than that, not just in money but in lives.
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.
Never a more frightening instance of "penny wise, pound foolish".
"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 patient who pays for the test gains nothing from the results.
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.
Yeah, I think the actual answer is that the number of tests on that page is not even remotely up to date, and the CDC has more important issues on its plate than updating it. As I understand it the UK testing criteria are very similar to the CDC's and also require travel to an affected country or contact with a confirmed case: https://www.gov.uk/government/publications/wuhan-novel-coron... The government here is just starting to roll out more general testing of the population to selected cities, but so is the CDC over in the US, and in both cases it's intended more to detect widespread spreading than to catch every individual case.
It's just probably not the most important thing to keep it continously updated on their website. The actual numbers aren't a secret or anything; there's a more up-to-date figure in the MMWR report on their website a couple of days ago, as well as the one just announced. (Though the MMWR figure only counts CDC tests, and apparently other laboratories have finally started carrying out their own tests in the US, including I believe some in California. That means there's probably not a single definite, up-to-date total for the number of tests anymore.)
A counterpoint - testing like this takes resources, and creates a backlog for other more pressing tests for patients. I mentioned this in another comment, but if I have a patient with pneumonia, I'm more than likely going to treat it the same way regardless of what the test shows me. Getting samples from everyone takes resources that lots of hospitals don't really have.
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.
But wouldn't you need to isolate pneumonia patient if they confirmed to have COVID-19? Also, curious, would you be more inclined to use some of the medicine that other countries claimed to be effective against COVID-19? Like Remdesivir and chloroquine?
In addition, at least until the outbreak becomes an uncontrolled epidemic in the US, you'd want to trace the contacts of any person confirmed to be infected with COVID-19 in order to try to try to stop the spread of the disease.
How do we know that testing for Coronavirus creates a backlog? I don't have enough information to say how the system works, but I imagine a nurse takes an additional blood test, and then someone sends that test to the CDC. The CDC tests the blood, and sends a response to the hospital.
I am curious to know more about the actual process.
There's a bureaucratic 'Catch-22' in each regulatory agency's rules for allowing emergency testing, & apparently no one willing to exercise the authority to break the logjam. See for example the unwound details in this thread (which is reporting roughly the same things as Dr. Gottlieb, just without the diplomatic mollycoddling of his former agency):
Yes. The tests are sufficiently unreliable that if there is no specific reason to believe that a particular person has been exposed, the results are just noise.
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.
The problem in such cases is the prior. If a false positive is 10%, 1%, 0.1% or 0.01% makes a huge difference. With 0.01% and two different tests, you will get a false positive in every 100'000'000 tests. Testing twice solves many of the issues. It also gives information about the sensitivity and specificity of a test.
> With 0.01% and two different tests, you will get a false positive in every 100'000'000 tests.
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.
We messed up a bunch of the first ones and we don’t really have centralized capacity to manufacture the tests at scale because of our privatized, outsourced healthcare system, we’re being prevented from using overseas ones (the senator from Hawaii is publicly begging Japan for tests), the CDC and other responsible agencies are in disarray from GOP gutting and malfeasance.
If tested I have to assume the patient will be charged for it, which depending on their insurance could easily be a cost of thousands of dollars if they are in a hospital or ER. We are going to experience a situation where sick people don't get tested and continue to infect others because health care is too expensive. The cost of health care is very much going to exacerbate this situation.
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.
[0] https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html
[1] https://www.gov.uk/guidance/coronavirus-covid-19-information...