Dr Karl Morten - UK researcher based at Oxford University

The problem with that is that this test is scientifically validated and FDA approved (which is a specified independent non-profit authority). It's scientifically validated that it measures antibodies, the problem is just that this measurement is essentially meaningless. There's sort of two levels of approval, once validating it's accuracy and once an approval process for a specific condition (after which it is covered by insurance companies).

So what could easily be done is that the seller has to ensure the purchaser is informed that the test isn't scientifically validated for any given condition, but I don't think that changes anything because people are taking this test out of desperation and not because it has proven scientific value. It's no different to the supplement industry. Most of those things are also meaningless, but people still buy all sorts of things with their own money.

What should be done is that more researchers and doctors point out that these tests are meaningless.

 

They are the very definition of a scam because they do not accurately diagnose a disease yet are being marketed as diagnostic of dysautonomia. These tests are not just being sold as research assays. They are being sold to patients and clinicians with the clinical interpretation being that these tests measure the cause of clinical symptoms of dysautonomia. But as we know, these tests cannot reliably distinguish between patients and controls in research studies (as shown in several German and Norwegian papers). If these tests were reliable, don't you think your GP would be able to order these tests for you in a normal government-run lab, not some dodgy German commercial lab?

 

These results ARE being used to establish a fake diagnosis of Lyme disease and expose patients with diagnoses like fibromyalgia and ME/CFS to long-term antibiotic therapy for a disease they don't have. I know this for a fact but this is all I can say publicly.

 

The technology is not in itself the issue. It is the nature of 'having an antibody'.
As I said, we all have antibodies that bind to everything. In Graves disease the tests show that patients' sera stick more antibody to a thyroid peroxidase substrate than healthy people (mostly, there are plenty of exceptions but the test is still skewed hugely to patients).

That might be due to patients having more antibody molecules that bind or ones that bind more strongly. In the body unless an antibody has a dissociation constant of about 10^-8 for its antigen it probably doesn't ever bind long enough to matter. But if the binding constant that determines whether or not antibodies stick to antigen in an ELISA well is different then you start measuring something very different. And binding constants are affected by antigen being immobilised on plastic. Moreover antibodies love binding to plastic, which is why an irrelevant protein like casein is used to 'block' that.

When all is done and dusted you have a test that gives you an optical density based on how much stain has been fixed to the antigen or the plastic which has a good chance of being more in patients who really have antibodies with a greater power to bind in vivo, but not guaranteed by any means. But the total amount of antibody stuck to the plate in any particular case is never mentioned because it depends mostly on the size of the plate, the dose of serum and other irrelevances.

So the test only gives a result with any meaning at all if you can consistently show two populations of sera show different binding when antigen is there. And as far as I am aware we don't have that for most of these receptors, if any. And some proteins probably pick up antibody for non-specific charge reasons. The list reasons for an artifactual result is almost endless.

So a test may be consistent in that the same sample gives the same result on several occasions compared to no antigen present, but as to whether it is 'accurate' that may be unanswerable. It doesn't measure amount as such. It may measure the wrong affinity, and so on.

As I said, people have run research programmes for several years on antibodies that turned out mostly to bind to plastic, or the blocking agent. Most research papers on antibody levels are junk. So the test is 'fake' in that it is presented as telling you something biological, when it may simply indicate some irrelevant physical chemistry.

 

re discussion above re autoantibody tests - the rituximab trial failed [no evidence that autoantibodies are clinically relevant] so what's the point of these tests?

 

I think someone has suggested (above) that the German Government should get involved i.e. to regulate/stop this. I periodically meet people who are involved in ME/CFS lobbying there - I can mention this discussion. Also, they/other members of those groups may be on this forum?

 

Great explanation - thank you.

 

Presumably the PhD studentship mentioned in the last message