7 ms·

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 purchas

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. Hopefully the FDA may be finally getting its act together and fast-tracking approval of local tests: https://twitter.com/ScottGottliebMD/status/1233021681918193664 https://twitter.com/ScottGottliebMD/status/12330216819181936... [0] https://www.politico.com/news/2020/02/20/cdc-coronavirus-116529 https://www.politico.com/news/2020/02/20/cdc-coronavirus-116... [1] https://threadreaderapp.com/thread/1231944326827081729.html https://threadreaderapp.com/thread/1231944326827081729.html

Reelin 7y ago
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. [1] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detecti... [2] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-primer-probes.html https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-p...
- orblivion 7y ago
  Maybe false negatives or even false positives could be a liability issue?
  - claudeganon 7y ago
    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.
    - orblivion 7y ago
      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.
  - Reelin 7y ago
    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.
    - prepend 7y ago
      Isn’t the idea of review to confirm that “highly unlikely?” Without review, unscrupulous (or incompetent) vendors could make a test with unknown usefulness.
      - Reelin 7y ago
        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.
  - oceanghost 7y ago
    Type-1 and Type-2 errors... :-) https://en.wikipedia.org/wiki/Type_I_and_type_II_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.
- whatshisface 7y ago
  >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.
  - saber6 7y ago
    Interesting regulation. Is this an attempt to prevent a short-sighted, mass-depletion of valuable supplies under peak-crisis scenarios?
  - Reelin 7y ago
    The natural question is then: why haven't the people in charge issued some sort of exemption or blanket authorization in this case?
    - 3fe9a03ccd14ca5 7y ago
      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.
      - metalliqaz 7y ago
        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
      - munk-a 7y ago
        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.
- fredgrott 7y ago
  because of the original screw up went vaccines were first invented during he 1950s, people died..
  - dwnvoted2hell 7y ago
    People still die from bad vaccines, just not normally in the US.
- milesvp 7y ago
  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.
  - jshevek 7y ago
    This is something the media should be discussing more, to motivate legislators to fix ASAP.
    - Muuuchem 7y ago
      Only except our media has absolutely no interest in promoting actual positive change, sadly...
      - jpster 7y ago
        But really, it’s ridiculous that lawmakers and policymakers cannot see the harm done by these rules, themselves.
    - TuringNYC 7y ago
      Except most of the media is too busy with sound bites and simple review, not deep analyses.
- Natsu 7y ago
  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.
  - koheripbal 7y ago
    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.
    - Natsu 7y ago
      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.
- rolph 7y ago
  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
  - Reelin 7y ago
    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.html https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs...
- rolph 7y ago
  >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
  - lozaning 7y ago
    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.
    - rolph 7y ago
      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
      - Reelin 7y ago
        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.
        rolph 7y ago
        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 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.aspx https://medicalcountermeasures.gov/app/barda/coronavirus.asp...
- gumby 7y ago
  > 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?
  - reureu 7y ago
    ^^ 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.
- DrScump 7y ago
  why should a non-invasive diagnostic test require any sort of approval? Because false negatives are worse than no test at all / unknown.
  - mlonkibjuyhv 7y ago
    100 false positives for every actual positive is also pretty bad.
tozeur 7y ago
Reagent
dwnvoted2hell 7y ago
Willing to be wrong here, but the task of spinning off even thousands of infectious disease for a disease that is still little known does not seem to be a trivial task. We just had a huge scandal over a silicon valley company botching blood tests, and those were well known, well documented tests that honestly were ideal cases (as I understand) for what they were trying to do.

Reelin 7y ago

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. [1] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detecti... [2] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-primer-probes.html https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-p...

orblivion 7y ago
Maybe false negatives or even false positives could be a liability issue?
- claudeganon 7y ago
  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.
  - orblivion 7y ago
    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.
- Reelin 7y ago
  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.
  - prepend 7y ago
    Isn’t the idea of review to confirm that “highly unlikely?” Without review, unscrupulous (or incompetent) vendors could make a test with unknown usefulness.
    - Reelin 7y ago
      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.
- oceanghost 7y ago
  Type-1 and Type-2 errors... :-) https://en.wikipedia.org/wiki/Type_I_and_type_II_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.
whatshisface 7y ago
>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.
- saber6 7y ago
  Interesting regulation. Is this an attempt to prevent a short-sighted, mass-depletion of valuable supplies under peak-crisis scenarios?
- Reelin 7y ago
  The natural question is then: why haven't the people in charge issued some sort of exemption or blanket authorization in this case?
  - 3fe9a03ccd14ca5 7y ago
    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.
    - metalliqaz 7y ago
      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
    - munk-a 7y ago
      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.
fredgrott 7y ago
because of the original screw up went vaccines were first invented during he 1950s, people died..
- dwnvoted2hell 7y ago
  People still die from bad vaccines, just not normally in the US.
milesvp 7y ago
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.
- jshevek 7y ago
  This is something the media should be discussing more, to motivate legislators to fix ASAP.
  - Muuuchem 7y ago
    Only except our media has absolutely no interest in promoting actual positive change, sadly...
    - jpster 7y ago
      But really, it’s ridiculous that lawmakers and policymakers cannot see the harm done by these rules, themselves.
  - TuringNYC 7y ago
    Except most of the media is too busy with sound bites and simple review, not deep analyses.
Natsu 7y ago
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.
- koheripbal 7y ago
  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.
  - Natsu 7y ago
    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.
rolph 7y ago
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
- Reelin 7y ago
  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.html https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs...
rolph 7y ago
>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
- lozaning 7y ago
  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.
  - rolph 7y ago
    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
    - Reelin 7y ago
      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.
      - rolph 7y ago
        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 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.aspx https://medicalcountermeasures.gov/app/barda/coronavirus.asp...
gumby 7y ago
> 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?
- reureu 7y ago
  ^^ 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.
DrScump 7y ago
why should a non-invasive diagnostic test require any sort of approval? Because false negatives are worse than no test at all / unknown.
- mlonkibjuyhv 7y ago
  100 false positives for every actual positive is also pretty bad.

tozeur 7y ago

Reagent

dwnvoted2hell 7y ago

Willing to be wrong here, but the task of spinning off even thousands of infectious disease for a disease that is still little known does not seem to be a trivial task. We just had a huge scandal over a silicon valley company botching blood tests, and those were well known, well documented tests that honestly were ideal cases (as I understand) for what they were trying to do.