His Flatulence says the FDA can't regulate laboratory tests

[Bomb#20]

"Over the 4 days of infection before the typical time of symptom onset (day 5), the probability of a false-negative result in an infected person decreases from 100% (95% CI, 100% to 100%) on day 1 to 67% (CI, 27% to 94%) on day 4. On the day of symptom onset, the median false-negative rate was 38% (CI, 18% to 65%). This decreased to 20% (CI, 12% to 30%) on day 8 (3 days after symptom onset)..."

I am flushing their <expletive deleted> down the toilet because, quite frankly, it doesn't matter what the tests that they have access to for their study can detect, when. What matters is what a curacy can be achieved with tests. So a bunch of <expletive deleted> ass tests can't pass FDA. No skin off my nose.

It isn't a problem for my lab. Then again our testing is about an order of magnitude more sensitive than conventional Covid testing models so ¯\_(ツ)_/¯ (we're still working hard on it; FDA did set a pretty high bar, but we're pretty close).

Are you under the impression that the point in dispute is what's a problem for your lab? This argument is about your implausible claim that "No test for contagious disease gets through the FDA with statistically significant false negatives." You have presented no evidence that the tests in the study "can't pass FDA". You simply take it on faith, based apparently on having irrationally chosen a Bayesian prior of 0.0%, that Johns Hopkins must have been studying tests that aren't as good as those that "get through the FDA".

Here, straight from the horse's mouth, is what the FDA is saying about LabCorp's RT-PCR test, which is currently in general use in the U.S.:

"LabCorp’s COVID-19 RT-PCR Test is authorized for use
on respiratory specimens collected from individuals
consistent with the EUA.
...
What does it mean if the specimen tests negative for
the virus that causes COVID-19?
A negative test result for this test means that SARS-
CoV-2 RNA was not present in the specimen above the
test’s limit of detection. However, a negative result does
not rule out COVID-19 and should not be used as the
sole basis for treatment or patient management
decisions. It is possible to test a person too early or too
late during COVID-19 infection to make an accurate
diagnosis via LabCorp’s COVID-19 RT-PCR Test. In
addition, asymptomatic people infected with COVID-19
may not shed enough virus to reach the limit of detection
of the test, giving a false negative result.
...
When diagnostic testing is negative, the possibility of a
false negative result should be considered in the context
of a patient’s recent exposures and the presence of
clinical signs and symptoms consistent with COVID-19.
The possibility of a false negative result should
especially be considered if the patient’s recent
exposures or clinical presentation indicate that COVID-
19 is likely, and diagnostic tests for other causes of
illness (e.g., other respiratory illness) are negative."
​

https://www.fda.gov/media/136149/download

But by all means, feel free to flush the FDA's excrement down the toilet too.

All you can do is read things that have no bearing on whether testing methods be improved upon, and how.

But we aren't arguing about whether testing methods can be improved upon. Everyone here is in agreement that they can be. As for how they can be improved on, that was the subject of the article I linked in post #4.

In fact, the earlier tests are much more <expletive deleted>. There were fewer [and less-]functional binding antibodies and antigens just a month ago, and you're using historic averages to determine how and whether false negatives are actually avoidable? That's cute. It's really <expletive deleted> stupid... But cute.

Where the heck do you imagine I claimed false negatives aren't avoidable? Why do you persistently make up garbage about other posters? Seriously, dude, what is wrong with you?

I'm using historical averages to determine that when you wrote "So, my job now is actually working at a bioassay company. ... It is the false negatives that absolutely are not allowed.", you were describing the policy of your employer. You were not describing the policy of public health authorities; you were not describing the policy of the FDA; and you were not describing the policy the American people need in order for as many of us as possible to live through this epidemic.

If we decide that since false negatives are actually avoidable we will choose actually absolutely not to allow them, then we will delay testing until a test that avoids them becomes available, and an awful lot of people will die unnecessarily while we wait for that to happen.

 

[Jarhyn]

Are you under the impression that the point in dispute is what's a problem for your lab? This argument is about your implausible claim that "No test for contagious disease gets through the FDA with statistically significant false negatives." You have presented no evidence that the tests in the study "can't pass FDA". You simply take it on faith, based apparently on having irrationally chosen a Bayesian prior of 0.0%, that Johns Hopkins must have been studying tests that aren't as good as those that "get through the FDA".

Here, straight from the horse's mouth, is what the FDA is saying about LabCorp's RT-PCR test, which is currently in general use in the U.S.:

"LabCorp’s COVID-19 RT-PCR Test is authorized for use
on respiratory specimens collected from individuals
consistent with the EUA.
...
What does it mean if the specimen tests negative for
the virus that causes COVID-19?
A negative test result for this test means that SARS-
CoV-2 RNA was not present in the specimen above the
test’s limit of detection. However, a negative result does
not rule out COVID-19 and should not be used as the
sole basis for treatment or patient management
decisions. It is possible to test a person too early or too
late during COVID-19 infection to make an accurate
diagnosis via LabCorp’s COVID-19 RT-PCR Test. In
addition, asymptomatic people infected with COVID-19
may not shed enough virus to reach the limit of detection
of the test, giving a false negative result.
...
When diagnostic testing is negative, the possibility of a
false negative result should be considered in the context
of a patient’s recent exposures and the presence of
clinical signs and symptoms consistent with COVID-19.
The possibility of a false negative result should
especially be considered if the patient’s recent
exposures or clinical presentation indicate that COVID-
19 is likely, and diagnostic tests for other causes of
illness (e.g., other respiratory illness) are negative."
​

https://www.fda.gov/media/136149/download

But by all means, feel free to flush the FDA's excrement down the toilet too.

All you can do is read things that have no bearing on whether testing methods be improved upon, and how.

But we aren't arguing about whether testing methods can be improved upon. Everyone here is in agreement that they can be. As for how they can be improved on, that was the subject of the article I linked in post #4.

In fact, the earlier tests are much more <expletive deleted>. There were fewer [and less-]functional binding antibodies and antigens just a month ago, and you're using historic averages to determine how and whether false negatives are actually avoidable? That's cute. It's really <expletive deleted> stupid... But cute.

Where the heck do you imagine I claimed false negatives aren't avoidable? Why do you persistently make up garbage about other posters? Seriously, dude, what is wrong with you?

I'm using historical averages to determine that when you wrote "So, my job now is actually working at a bioassay company. ... It is the false negatives that absolutely are not allowed.", you were describing the policy of your employer. You were not describing the policy of public health authorities; you were not describing the policy of the FDA; and you were not describing the policy the American people need in order for as many of us as possible to live through this epidemic.

If we decide that since false negatives are actually avoidable we will choose actually absolutely not to allow them, then we will delay testing until a test that avoids them becomes available, and an awful lot of people will die unnecessarily while we wait for that to happen.

You need to read back into the thread to some of your earliest complaints about the FDA testing requirements with respect to comparison to PCR. You have lost the thread. Maybe on purpose. I'm not going to let you pivot to irrelevancies here. You whinged about PCR being the standard and the FDA not approving additional testing models.

Well, guess what? They fucking shouldn't. Because there ARE better tests in the pipeline so why would the FDA approve even more of the currently available shitty tests?

 

[Bomb#20]

You need to read back into the thread to some of your earliest complaints about the FDA testing requirements with respect to comparison to PCR.

Where by "my earliest complaints", you're referring to the complaints of Dr. Michael Mina, MD? The Harvard epidemiology professor? Those complaints?

You have lost the thread. Maybe on purpose. I'm not going to let you pivot to irrelevancies here.

You know, that almost sounds like a veiled confession that you've been peddling disinformation. By "pivot to irrelevancies" you are referring to the fact that I have established that your counterarguments were based on falsehoods. That's not "losing the thread". That's refuting your failed attempts at rebuttal. If you don't want the debate to focus on your falsehoods, then withdraw those arguments and offer new ones.

No doubt you'd have preferred if I'd decided you're an expert so I should just take your word for it that you're right overall, even though you keep saying blatantly incorrect stuff along the way. But I haven't seen Dr. Mina say blatantly incorrect stuff along the way. So if you don't mind too much, I'm going to continue to assume that he's likely to be at least as expert as you are. So if you're nonetheless right about the lack of merit of antigen testing, that will have to be shown by arguments that don't contain blatantly incorrect stuff, not by an appeal to your authority.

You whinged about PCR being the standard and the FDA not approving additional testing models.

Well, guess what? They <expletive deleted> shouldn't.

Why you imagine swearing at people for doubting you improves the quality of your case is a mystery.

Because there ARE better tests in the pipeline

Where "better", I take it, is a rank-ordering you equate with "more sensitive"? There are other metrics in addition to sensitivity that tests can be ranked according to. How did you establish that sensitivity is the be-all and end-all of test betterness? By the fact that increasing test sensitivity happens to be the component of the testing problem that you personally happen to be working on?

so why would the FDA approve even more of the currently available <expletive deleted> tests?

Well, in the first place, nobody was arguing for approving even more of the currently available tests; that's just you setting up yet another strawman. Mina's arguing for approving currently unavailable tests, precisely so they'll become available.

And in the second place, although no doubt in your sensitivity-uber-alles worldview one less sensitive test is exactly as worthless as another less sensitive test, in point of fact different less sensitive tests differ from one another along other axes orthogonal to sensitivity. One test may be better than another test along one axis, but worse than that other test along some other axis. Consequently, one such test may be more appropriate than another for some patients in some clinical situations, and less appropriate for other patients in other situations. So there's a benefit to having a variety of tests with different characteristics. That is why the FDA would, if it were optimizing for ending the epidemic, approve a new test that's just as insensitive as some existing test.

The logic of your position doesn't only imply the FDA should not approve less sensitive tests. The exact same reasoning you're using would lead to the conclusion that the FDA should also withdraw authorization from the LabCorp test and the other RT-PCR tests now in common use, just as soon as your bioassay company proves to the FDA that you've achieved your projected order-of-magnitude improvement in sensitivity. In the world you're working toward, there will be only one test: yours. So if a health care professional is currently choosing test A over test B, because the FDA authorized both and she thinks test A is more appropriate given her patient's presentation, your position implies that she should be denied that sort of flexibility. She shouldn't be allowed to test anyone at all except with your test.

According to Dr. Mina, to stop this epidemic we need to be testing over ten million people a day. So tell us, if it isn't too much of a violation of your NDA, how many of your new improved tests has your bioassay company performed so far? And how soon are you going to be able to ramp up production to ten million tests a day?