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.

This is something the media should be discussing more, to motivate legislators to fix ASAP.

Only except our media has absolutely no interest in promoting actual positive change, sadly...

But really, it’s ridiculous that lawmakers and policymakers cannot see the harm done by these rules, themselves.

Except most of the media is too busy with sound bites and simple review, not deep analyses.

>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.

The natural question is then: why haven't the people in charge issued some sort of exemption or blanket authorization in this case?

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.

> As opposed to corporate bureaucracies?

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?

Employee counts:

- 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

You think corporate bureaucracies are bad now? What until they’re a legally protected monopoly.

That's a non sequitur. If they are only concerned with self preservation, you would expect them to bend more rules to keep away bad press

Yes, if only there wasn't a CDC around to help develop the tests in the first place. /s

The good comes with the bad. There is a lot of nuance that such blanket statements generally don't capture.

They also tend to lose function when they are gutted by politicians.

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.

You may be right, but I think that's a call for medical professionals to make. I do hope they fast track things without unnecessary delay, though.

> 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.

[1] https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs...

Maybe false negatives or even false positives could be a liability issue?

Type-1 and Type-2 errors... :-)

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 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.

Hm, okay. Apologies for the misinformation.

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.

Isn’t the idea of review to confirm that “highly unlikely?”

Without review, unscrupulous (or incompetent) vendors could make a test with unknown usefulness.

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.

[1] https://www.thermofisher.com/us/en/home/references/gibco-cel...

Is it not enough to have the complete genome? https://www.ncbi.nlm.nih.gov/nuccore/NC_045512

you are looking at a primary sequence-

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 start altering the virus-

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

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:

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...

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]

that is the way federal government engages.

  why should a non-invasive diagnostic test require any sort of approval?

Because false negatives are worse than no test at all / unknown.

100 false positives for every actual positive is also pretty bad.

because of the original screw up went vaccines were first invented during he 1950s, people died..