What else does it not mean - it does NOT apply to manufacturers of tests and tests that labs or others purchase like Roche, Abbott, Hologic

It ONLY applies to CLIA laboratories, which are legal entities approved to perform diagnostic tests for humans - like a hospital lab...

2/
So this does NOT mean that any research or industry lab can start just testing for COVID. Repeat - if you have a research lab - this does NOT mean you can start testing people as diagnostic tests.

It DOES apply to clinical laboratories certified under CLIA to test humans...

3/
So what is it?

Under normal non-public health emergency times, a high complexity CLIA clinical laboratory is allowed to create and use their own tests for their own patients.

It is considered a part of practicing medicine for example and pathologists can create new tests

4/
So if I am a medical director of my hospital lab, I am allowed normally to create, say, a new cholesterol test and use it only in the CLIA lab I direct - it is referred to as a “Laboratory Developed Test” or LDT.

I can not use it elsewhere unless I get FDA approval.

5/
But I can usually use my new test in my CLIA lab without getting FDA approval - again only in my lab though.

That’s under normal times....

6/
When the HHS declared a public health emergency in January, it put in place a requirement that CLIA labs wanting to create an LDT for COVID19 had to get FDA approval. For LDTs this is not normally a thing.

The approval process is called Emergency Use Authorization or EUA .

7/
So, since January, any CLIA laboratory wanting to test people for COVID has to gain EUA approval from FDA in order to do so.

Note: non-CLIA laboratories cannot legally perform clinical diagnostic tests anyway, so this pertained to any lab wanting to test people.

8/
However the process became unwieldy quick.

First it prevented essentially all CLIA labs from being able to test for CoVID. There went Feb and most of March without any tests performed in the US.

9/
So then the FDA realized they couldn’t get through the applications quick enough so they told labs wanting to create an LDT for #COVID19 to just go ahead, submit the EUA application and start testing immediately (even before hand) and eventually the FDA would get back to you

10/
And that brings us to today - the US has a LOT of CLIA labs - many are performing their tests, waiting for the FDA to get back to them about their EUA application...

So it became a bit of a joke to get an EUA since so many labs are testing with just an application submitted

11/
This executive order just removed the extra hurdle of getting an EUA for a CLIA LDT and gave the rights to perform an LDT back to the CLIA labs/CLIA directors to sign off on.

This does NOT mean that a manufactured test like a rapid test can be made/used w/out an EUA...

12/
This is a good thing because while a CLIA lab has a relatively limited scope of testing and ideally high levels of expertise, a manufactured test that is sold across the country must be evaluated and given a stamp of approval. We need this oversight out in the “wild”

13/
Now we just have to get the FDA or to create a pathway for pathway for assessing and approving rapid tests outside of CLIA through a new public health testing pathway.

14/14
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