Accessing Tests Not Approved For Clinical Diagnosis

[undiagnosed]

Has anyone had any success accessing tests not approved for clinical diagnosis in the US? If so, what was your approach?

As an example, consider the Virochip assay. The UCSF Viral Diagnostics and Discovery Center website states the following:

Note that the UCSF Viral Diagnostics and Discovery Center is a research laboratory and cannot perform individual patient testing due to federal regulations. We are unable to perform clinical diagnostic testing, and only recommend that patients see their personal physician to discuss available clinical test options.

Yet, there must be exceptions. For example, Joe DeRisi in his TED talk, "Solving medical mysteries", discusses how his group diagnosed a patient with Parainfluenza-4 when the hospital couldn't figure out what was wrong after a bunch of testing. The Virochip assay was used for this case and as stated above, it is not approved for clinical diagnosis.

 

[Research 1st]

Do you mean approved for CFS? I'll answer as if you do.

No test is approved for CFS, but never can be, as CDC state in their blueprint of CFS that chronic fatigue syndrome must be unexplained, not explained to qualify for it!

So you if you have a test that proves you are biomedically fatigued, you exceed CDC criteria, as the aforementioned fatigue has an explanation.

To answer your question This is why there is no approved test for CFS as it cannot happen as then you no longer have CFS according to CDC.

This is how CFS patients move away from CDC CFS (Fukuda criteria) into something where tests can be
permitted to be used, that are approved (in terms of demonstrating why there are 'symptoms'.) in the following...

Conditions more stringent than CDC CFS:
1 CFS Canadian Consensus Crteria (CCC CFS)
2 ME - ME International Consensus Criteria (ME-ICC)
3 Chronic Lyme
4 POTS /Autonomic Nervous System Dysfuncton -

Example of approved tests used for clinical diagnosis from conditons above:
1 Heart rate/bp changes showing orthostatic intolerance
2 Various immune, inflammatory markers etc
3 Blood tests for various co-infections, viruses, cardiac ECG changes etc (same as above!)
4 Tilt test, Valsalva, QSART, ECG changes, blood volume regulating hormones, autoantibodies.

NB: Some patients chose to reject CFS outright when this happens (access to tests previously prohibited).

Others remain with the original diagnosis + their new one because they believe the above is all 'CFS' anyway just more severe presentation, and subsets of the same illness (others wouldn't agree as they refer back to the CDC criteria of CFS).

So in conclusion:

There are numerous specialist tests to 'prove' you have something 'more' than unexplained CDC CFS I could probably list 15-20 tests, but as I said, none are approved as then the CFS you would have had, is surpassed and cannot exist, because CFS fatigue is explained, which CDC will not permit.

Hope that makes sense.

 

[undiagnosed]

@Research 1st, I didn't mean tests specifically for CFS. I am referring to any test that has not been approved for clinical diagnosis of any disease under CLIA or FDA regulations. I gave the example of the Virochip assay, but there are many other research assays that are not approved for clinical diagnosis in the US. As I mentioned, I have seen exceptions to the regulations and was really looking to see if anyone has success getting around the regulations to access a test.

 

[Research 1st]

Ohh sorry, never mind, at least I got to see how many spelling errors I make per paragraph.

I'd like to help, but I'm thinking perhaps an answer to your question will be restricted on a CFS forum,as members experiences of non approved tests in general, will actually be regarding their own disease or similar.

E..g. Yes I got around the reg's and used this test to prove condition.X.

But if you think about it, will anyone here willingly tell you this? As then by telling you, they risk the regulatory board clamping down on it and erasing a diagnosis they just obtained - via obtaining a test not approved for clinical diagnosis.

E.g. If they tell you in public, about their own 'non approved test', may then be withdrawn becomes the Internet finds out.

The exception would be if they answer your question, about a disease they don't have. So maybe in that respect, someone will answer you.

 

[undiagnosed]

@Research 1st, no problem, haha. Ya, I get what you're saying and I can see that point if it were in regards to a specific test from a specific company; That could get people in trouble and we would want to stay clear of that. What I am looking for is more a means for accomplishing it. Was there a certain clause of the regulations that was used to justify it? Was there someone who was able to bend the rules? Did you use social engineering to convince the place running the test that you were a doctor or researcher? Stuff along those lines.