nortex97 said:
2PacShakur said:
nortex97 said:
Thomas Ford 91 said:
Flexbone said:
SUag said:
Regardless of who caused it, lack of US testing has undoubtedly increased the spread. Just imagine if anyone who wanted a test could have received a test, even if only since March 1st.
Particularly when you have people out there that are potentially asymptomatic yet contagious like Sen. Rand.
This kind of oblivion is EXACTLY how a liberals' mind works. Absolutely zero concept of reality. The test had to be invented for a virus that was unknown. But hey...even though you don't know **** about 9th grade biology, please tell us what should have happened.
How long does it take to make a test for a novel virus? The Chinese released the genome map on January 9th. The Germans had a working test by January 16th.
A week seems like a reasonable time to develop a test. But, I do think the last time I took biology may have been 9th grade.
Have you ever studied CLIA'88 or FDA regulations for how to document, submit, and approve a test? In the diagnostic industry, we know it almost invariably takes at least a year longer to get a test approved/cleared in the US vs. Europe.
There are benefits to our stringent standards, but also many drawbacks, as seen in this crisis.
Not under emergency provisions. Did you read the link you provided? Like seriously:
Quote:
The new guidelines state that commercial test developers can launch an assay as soon as it is validated to previously guided standards, provided the companies subsequently pursue EUA within 15 days. This is similar to the guidance issued to labs seeking authorization for laboratory-developed testing.
It's not that difficult for a PCR based assay. Here's the information for the WHO assay. (Edit: forgot link.) The test is basically can you find and amplify stretches of viral DNA (well, technically it's an RT-PCR so the beginning material is RNA until DNA outnumbers RNA) that is specific to C19. Maybe a few of the targets are for the more generalized coronavirus family, but there will be more specific pieces to identify C19 over SARS, for example.
You just linked to a document from WHO that only one nurse I have ever met would be able to follow, and it would require hours. PCR (polymer chain reaction) tests are not simple. Roche guards their rights to such tests like Apple guards iphones. Some creative companies like cepheid have come out with easy to use products, but in general it still requires a clean room. It's certainly not as simple as 'coming out with a PCR based assay' to make it commonly available.
She wouldn't need to understand the whole thing, just the last 3 pages where it says add x microliters of y to a solution mix for the reaction. The first 10 pages are just to document why they are doing the last 3 pages. Years ago, I've given instructions like those to undergrad students just to benchmark how much attention they'll need. Furthermore, of course it takes hours. Any and all PCR reactions require a few hours. (Edit: these reactions could take 30 mins total, +/-, as these are relatively short segments they're amplifying.)
I won't comment about clean rooms and whether GLP/CLIA standards are being followed or if IP is being broken (I didn't say anything about "borrowing" their primers as people can come up with their own, well,
maybe not the CDC this time around). Considering most tests are operated in a state, university, or hospital lab setting, the room(s) they perform these are likely already following those standards. Nor am I commenting on whether PCR is the best test applicable for millions of tests. What I am saying is that developing and validating these tests is generally easy and this test could have been ramped up until better solutions arrive.
If you ever seen the show Border Patrol, the quick test they do to identify an illegal drug is the type of test you want. Those tests require more time as you have to identify a specific antibody with avidity towards a specific C19 target, and then develop the overall kit/materials A PCR based test is your bridge to those. Heck, the University of Minnesota had a volunteer task force of graduate students running samples using donated materials from their own labs until they could IQ/OQ/PQ the high throughput systems.
