Please take the lyme survey, FDA trying to stop labs from testing for lyme

[roxie60]

http://lymedisease.org/research/surveys.html

the fda is trying to clamp down on labs doing lyme testing. Please take survey to help stand up against fda plan.

 

[roxie60]

http://lymedisease.org/news/lymepol...ions&utm_campaign=FDA+Survey&utm_medium=email

 

[duncan]

Done.

Thanks for posting.

 

[Sushi]

Took the survey--8 minutes.

Sushi

 

[andre79]

I have read somewhere, don't remember where, that lyme disease is a clinical diagnosis instead of a serological one. What's the opinion of the CDC about that? How could a doctor diagnose lyme disease by the symptoms, when this illness can mimic hundreds of other health conditions?

I have mixed feelings about FDA trying to regulate the lyme tests. We need more accurate tests, with better rates of effectiveness, reliable ones. In my case, i would like to trust the negatives test that i received, but when you read in the internet that the test misses 50% of the cases, i wonder, what's the point of doing the test in the first place.

What's the difference between the Igenex tests from the other ones? Why does Igenex diagnoses more positives than the other laboratories?

Sorry, i was just wondering and writing random thoughts.

 

[roxie60]

I have the same thoughts, at times angry that these tests are given credibility by the shear fact drs are told to use them but most drs no little about lyme and coinfections. with tjis margin of error they do a disservice yo patients.

It is my understanding igenex cks for more strains. Quest and labcorp ck gor one strain. Also lyme and tdb's are igenex only focus, specialty.

By now there should be better tests, more conclusive research and less trial by error treatment plans

 

[roxie60]

How dan they clinically dx, experience. Yes the great imitator but when you start reading, hearing all the stories there is much in common, a degenerative path these bugs take on the body. Some just get much sicker faster probably due to genetic differences

 

[Valentijn]

To take the survey, you need to be living in the US.

 

[duncan]

Technically, Lyme is a clinical diagnosis. Lab work is diagnostically supportive. But outside of the classic bull's eye EM rash, no symptoms are Lyme-specific, not even swollen knees (back in the mid '70's in Lyme, Ct there were a cluster of cases of children with swollen knees that were at first diagnosed with Juvenile RA - and we all know how that story ended.)

So lab work is important to help either confirm Lyme or rule it out.

That's where some of the problems really crystallize. For surveillance purposes, 20 years ago researchers decided that five out of ten bands - visible antibody reactions - had to be captured thru what's called a Western Blot for a case to be labeled Bb positive (this is for IgGs. For IgM's, i.e.acute cases, it's two of three bands). Remember, the algorithm generated for that threshold was meant for surveillance purposes only, originally.

That is not what happened, however. Instead, over time clinicians and researchers adopted the Dearborn, Michigan recommendations as diagnostic, almost as if through a default mechanism. Worse, thanks in great measure to the introduction of a Lyme vaccine, two very important bands - OspA (band 31) and OspB (band 34) - were yanked from consideration. So when labs such as Labcorp or Quest run blood work to check for Lyme, they do so without tapping those two Borrelia-specific bands.

In theory, accordingly, I can have WB results that come in at four bands IgG positive, and therefore be told by my doctor I do not have Lyme. That same test with my blood work, if run by IgeneX , apparently would include the two jettisoned Bands, 31 and 34, and if one of them appeared - BAM! I am Lyme positive. Don't forget, the purpose of the WB and its very specific band identification process is to help clinicians boost the confidence level of a Lyme diagnosis. Period. So, well, as a patient, if I can see I've tested positive for Bands 31 and 34 - I'm not sure I really care about the stupid algorithm - I've ratcheted up my confidence level that I have Lyme, and I may wish to act on that.

So, it is worth it for some patients to include those two extra bands. Unfortunately, it is very much a numbers game. I don't even know if such results, i.e. including either OspA or OspB, would be recognized by the CDC because of the implications to the algorithm that was embraced so many years ago. In my opinion they SHOULD be if only because the purpose of the test - of any current Lyme diagnostic - is confirmatory only.

Whew. This is way simplistic. I didn't even touch on that odd prerequisite, the ELISA. And there are other reasons many turn to iGeneX, some of which Roxie60 touched upon. Regardless, many IDSA supporters frown on the lab because of what they consider liberal interpretations, and the risk of generating too many false positive readings.

 

[anciendaze]

I would note that even the bullseye rash is said to mean nothing if you live in certain geographic regions. This leads to circular reasoning about incidence, because STARI is not a nationally reportable illness. The CDC is not interested in hearing about it. If you live in a region where b. burghdorferi is admitted to be prevalent you will likely be tested for Lyme if you present with the rash, though you might also be infected with b. lonestari, which will not test positive or culture easily.

Meanwhile, back at the B31 strain of borrelia burghdorferi used to define Lyme disease, we have the curious situation that this was not isolated from a patient, but from a tick. Even then, there was serial dilution used to isolate the most rapidly reproducing strain, in the belief this was the only one which produced significant infectious disease. This practically guarantees it will not be linked to chronic disease.

We next consider the genomic complexity of even this single strain. It turns out to have considerable variation, depending on which plasmids are in the bacteria infecting someone. This means the current official test is not completely reliable as an indicator of b. burghdorferi infection, or absence of same, and certainly not as an indication of infection with b. miyamotoi, which has now been found in U.S. patients. Reports that some such patients did test positive are another example of circular reasoning. How would you tell if a patient infected with b. miyamotoi did not test positive without a separate test for same? We have another case of wondering if the light in the refrigerator goes off when the door is closed.

The gap between laboratory science and clinical advice regarding Lyme is enormous. While such situations do arise from limitations caused by the primitive state of medical technology, the persistence of this situation for a full generation strongly argues that regulatory agencies have no desire to resolve the problem, unless this will make the disease go away.

 

[duncan]

Yep. All good points, anciendaze.

So, for all intents and purposes, we are all - at least in the US - tested for Lyme with a B31 kit. And I'm not even sure that is what they based the Dearborn criteria on - it may have been G39/40. Not sure about that. I think B31 originated in Europe, too, which is an irony if my memory is right (my memory is a 50/50 proposition, so roughly comparable to an ELISA, hehe)

And STARI is altogether a different saga. Is it Borrelia? Is it not?

You have the species issue presenting at the broad geographic level, the strain issue presenting, well, theoretically everywhere for Bb thanks to the variable antigens at play. On top of that you have the debate about which ticks can transmit what, where.

All the while there are the politics. Politics appear to be on the table for all of the above, most, if not all, of the time.