News and updates about the status of laboratory diagnostics for #COVID19 are coming thick and fast today.
A quick thread on that topic, starting with @HelenBranswell's timely article (why aren't you following her??) as a jumping off point:
1/n
A quick thread on that topic, starting with @HelenBranswell's timely article (why aren't you following her??) as a jumping off point:
1/n
First, we know that the CDC has tested few cases of possible #COVID19 patients.
In an MMWR from last week, they said they'd tested "1,007 people" but news this week is saying "<500"? I don't understand that discrepancy.
Suffice to say it's far, FAR below what is needed! 2/n
In an MMWR from last week, they said they'd tested "1,007 people" but news this week is saying "<500"? I don't understand that discrepancy.
Suffice to say it's far, FAR below what is needed! 2/n
Second, the CDC's developed PCR assay (which was described w/ sequences/primers back in January) *was* distributed to some (12+) public health labs.
But some component of that gave some labs problems (1 of 3 probes? a neg control? unclear to me)
cidrap.umn.edu/news-perspecti…
3/n
But some component of that gave some labs problems (1 of 3 probes? a neg control? unclear to me)
cidrap.umn.edu/news-perspecti…
3/n
Third, news that broke last night of a California patient w/o travel or contacts who wasn't tested (didn't fit criteria) ~10d ago, but DID test positive.
This means
1. criteria needs to be expanded!
2. testing needs to be available!
Both of these ASAP 4/n
statnews.com/2020/02/27/a-s…
This means
1. criteria needs to be expanded!
2. testing needs to be available!
Both of these ASAP 4/n
statnews.com/2020/02/27/a-s…
Clinical laboratories are full of very smart people with very advanced testing capabilities.
If we know how the CDC's #COVID19 test works (& they openly published this a month ago) why can *any* lab copy that test and develop their own test?
cdc.gov/coronavirus/20… 5/n
If we know how the CDC's #COVID19 test works (& they openly published this a month ago) why can *any* lab copy that test and develop their own test?
cdc.gov/coronavirus/20… 5/n
Diagnostic tests (their manufacture and marketing) are regulated by the FDA.
Many good, valid clinical diagnostic tests are developed in-house by a laboratory (lab-developed test, LDT). LDTs are not (usually) reviewed by the FDA.
BUT... 6/n
Many good, valid clinical diagnostic tests are developed in-house by a laboratory (lab-developed test, LDT). LDTs are not (usually) reviewed by the FDA.
BUT... 6/n
When the gov (HHS) declares a public emergency, that can initiate FDA's use of Emergency Use Authorization.
EUA means FDA *does* review & authorize diagnostic tests for that disease. Currently: #COVID19 (previously: Zika, 2009-H1N1 etc)
For more see: 7/n
EUA means FDA *does* review & authorize diagnostic tests for that disease. Currently: #COVID19 (previously: Zika, 2009-H1N1 etc)
For more see: 7/n
The process of a lab or kit manufacturer getting emergency use authorization is challenging in the best of times.
The EUA process is time-consuming, impractical and (importantly) NOT feasible for addressing the current need for #COVID19 testing 8/n
The EUA process is time-consuming, impractical and (importantly) NOT feasible for addressing the current need for #COVID19 testing 8/n
Side note: "Why allow the FDA to regulate testing ever??" you may wonder.
I'd say there's definite risk of fake or faulty "tests" made and sold by unethical people trying to capitalize on public fear.
Solution: streamline authorization for trusted diagnostic labs & groups! 9/n
I'd say there's definite risk of fake or faulty "tests" made and sold by unethical people trying to capitalize on public fear.
Solution: streamline authorization for trusted diagnostic labs & groups! 9/n
…BUT the APHL's original request included a request for the FDA to allow lab developed tests. And diagnostic or reference labs aren't part of any new CDC test kit distribution.
We're FAR below the capacity of what testing COULD be happening w/ faster, better collaboration. 11/n
We're FAR below the capacity of what testing COULD be happening w/ faster, better collaboration. 11/n
Clearly there are disappointing roadblocks for robust, rapid #COVID19 lab testing in the U.S.
Follow @UNC_Clin_Micro's example: encourage your elected officials to help streamline the FDA's EUA system and to support public & diagnostic labs!
We're all in this together! 12/12
Follow @UNC_Clin_Micro's example: encourage your elected officials to help streamline the FDA's EUA system and to support public & diagnostic labs!
We're all in this together! 12/12
@UNC_Clin_Micro Since screening criteria is a crucial part of testing, here's the current update, from @FCatalfumo. Notably, the untested CA patient had 1. severe symptoms 2. other causes ruled out.
Along w/ travel & contacts, that's now part of the criteria too.
13/12
Along w/ travel & contacts, that's now part of the criteria too.
13/12
@UNC_Clin_Micro @FCatalfumo Another important angle on #COVID19 diagnostics: the CDC's test being used deployed in the U.S. represents just one of VARIOUS options of targets/approaches that labs *could* develop if allowed.
The first test isn't the only test (or the best one?) 14/12
The first test isn't the only test (or the best one?) 14/12
@UNC_Clin_Micro @FCatalfumo Whoa! This is big news!!
I think we really need more details here, but it sounds like the FDA is moving toward exactly what was needed: letting labs develop their own #COVID19 tests!
I think we really need more details here, but it sounds like the FDA is moving toward exactly what was needed: letting labs develop their own #COVID19 tests!
@UNC_Clin_Micro @fcatalfumo More on the same report.
Clinical diagnostic labs, some with #COVID19 tests ready and waiting, were not allowed to do so due to FDA guidelines restricting diagnostic tests in emergency (EUA) settings.
What @ddiamond reports is: that may change! Hurray!
Clinical diagnostic labs, some with #COVID19 tests ready and waiting, were not allowed to do so due to FDA guidelines restricting diagnostic tests in emergency (EUA) settings.
What @ddiamond reports is: that may change! Hurray!
