is Igenex the ONLY reliable lab?

[valentinelynx]

Simple question: have you had a known tick bite? Had a suspicious rash? Neither is necessary for a Lyme disease diagnosis, but certainly raises the pre-test probability. Especially if the bite occurred in an area where Lyme disease is quite common. If either of these are true for you, then I would definitely pursue the possibility of Lyme disease. If they are not, it's something to consider if nothing else is working for you. BTW, IV antibiotics are used in the minority of cases.

 

[duncan]

@MisfitToy

IDSA = Infectious Diseases Society of America. So yes, these are ID doctors. They have been taught that Lyme is "hard to get, easy to cure". The first half of that statement was disproved recently when the U.S. revised its annual Lyme incidence estimates, which shot up tenfold, from 30,000 annually, to 300,000 annually.

The second half lingers.

 

[Valentijn]

Western Blot was the gold standard, then it was something else...

Western Blot was never the gold standard. It's always been known to generate a huge amount of false negatives, when compared to cultured blood samples or some such. Basically there is no gold standard, but Western Blot was considered good enough ... maybe because it generates few false positives, which would be useful for research purposes.

 

[Ema]

Western Blot was never the gold standard. It's always been known to generate a huge amount of false negatives, when compared to cultured blood samples or some such. Basically there is no gold standard, but Western Blot was considered good enough ... maybe because it generates few false positives, which would be useful for research purposes.

The Western blot is the gold standard. In common medical parlance, it simply means the best test available, not that it is 100% accurate. The gold standard test is subject to change over time as knowledge evolves.

However, apparently the AMA Style manual no longer likes "gold standard"'as a descriptor and has suggested using "criterion standard" instead. Except absolutely no one knows what that means so even more people are left scratching their heads. Sounds typical for a bunch of doctors...:thumbdown:

 

[Jonathan Edwards]

I had a Lyme test run recently, and it came back negative. It was sent to the Mayo Clinic, and they checked for Lyme IgG Western Blot and Lyme IgM Western Blot.

I did ask my doctor at the time about Igenex labs, but I was told we can't really use them because of insurance.

If I were to pursue this and press for Igenex ... well, it's just REALLY expensive. Are the tests run at Mayo really unreliable??

It sounds as if the test is unreliable in general. But for what it's worth I am not impressed by the Ingenex blurb and I doubt you would want to spend money on repeating the test. The Ingenex website seems to be written by people who are assuming that their customers are not familiar with immunology. It does not look like the sort of site I would have wanted to order in tests from. Specifically they have one test they call the ' 31kD epitope' or 'B. burgdorferi specific epitope 31kDa antigen'. The trouble is that to a professional immunologist this makes no sense. An epitope and an antigen are different concepts. An antigen can be 31kD but not an epitope. Western blots detect antigens, not epitopes. You could use them to probe for epitopes with cross blocking studies but then you would have a nomenclature for the epitope - like 31kD antigen 'epitope C' or '110-123 epitope'. You might call it '31kD antigen borrelia specific epitope', just about, but as it is it reads a bit like 'I live in a house small.' I doubt you would get something like this from Mayo because they know that they are providing to people who are familiar with immunology. If Ingenex are assuming they do not need to make immunological sense that does not bode well in my mind! (The labelling of the Western blot picture is also wrong and the bands look rather peculiar, but I will let that pass.)

 

[duncan]

Wow. You are entitled to your opinion, but to ever suggest a Mayo Lyme test over an IgeneX is just...well, crazy.

This is akin to recommending someone with an ME/CFS diagnosis go to Mayo.

 

[Jonathan Edwards]

Wow. You are entitled to your opinion, but to ever suggest a Mayo Lyme test over an IgeneX is just...well, crazy.

This is akin to recommending someone with an ME/CFS diagnosis go to Mayo.

How come? What reason is there to think that Igenex are more professional? You have said yourself that you are a great skeptic Duncan. Why are you not skeptical of Igenex?

 

[duncan]

You are quibbling over the use or misuse of epitope. This is sidestepping the real issues at play, like should 31k and 34k bands be included when the CDC says they shouldn't. Or whether there are too many false positives with Igenex. Or is the price worth the risk of embracing a shop that has a bulls eye on its back.

You are looking at window dressing when the question at hand is "Is this house safe?"

But to suggest Mayo...makes me shudder. They seem to be little more than an IDSA rubber stamp that just happens to hold the ME/CFS community in contempt as well, as far as I've been able to tell.

You are chasing windmills when there are real threats at play. IgeneX , for all its purported faults, including its costs, offers viable alternative testing in a diagnostic arena that is dominated by Harvard shops. It refuses to concede in a game that has been rigged for years. It looks for signs of the disease - like in those two bands - that everyone knows signal Bb, but have been verbotten by the Lyme Guard.

It stands in lone relief to a virtual diagnostic monopoly.

 

[Valentijn]

How come? What reason is there to think that Igenex are more professional? You have said yourself that you are a great skeptic Duncan. Why are you not skeptical of Igenex?

Mayo treats ME/CFS as a psychological disorder, ignoring a great deal of scientific evidence in order to stick with a dogmatic belief. Obviously they're not going to be wrong about absolutely everything, but I don't consider them to be a reliable authority or source of information.

 

[Dufresne]

Here's a fair and concise description of the mainstream tests and their uses.
http://www.columbia-lyme.org/patients/ld_lab_test.html

Notice they endorse the C6 as being a better test than the regular ELISA. Doesn't it make all the sense in the world to replace the ELISA with the C6?

I'm interested in what Duncan says about the C6, that it can reflect success of a treatment. I'm going to look into this. If it does, perhaps a study could be done on "post Lyme" patients undergoing treatment to see if their C6 results suggest the possibility of persistence.

Here's a little more about the C6
http://www.immunetics.com/lyme.html

 

[Dufresne]

Mayo treats ME/CFS as a psychological disorder, ignoring a great deal of scientific evidence in order to stick with a dogmatic belief. Obviously they're not going to be wrong about absolutely everything, but I don't consider them to be a reliable authority or source of information.

Yep. The hallowed Mayo Clinic has become synonymous with 'cutting edge' over the years. The name is regularly dropped in hopes of conveying the combination of reliability and up-to-dateness. However they've certainly lost street cred in our community.

 

[Sushi]

I did ask my doctor at the time about Igenex labs, but I was told we can't really use them because of insurance.

Many insurance companies pay for the Igenex test--Medicare paid for mine.

Sushi

 

[Alea Ishikawa]

Yabby,

I actually found IgeneX inexpensive. It was maybe ~$200 for IgG and IgM Western Blot outside of insurance. IgeneX test #188 and 189. I got mine done via my local primary doc (PCP), though I did get a specialist's request prior which probably helped push things along. The blood draw fee might've been like $25.

I ordered the test kit via their website, but it can also be done by phone. After you get the kit, you can check with your PCP's office to see if they can do the draw with their own employee, "spin" the tube(s), and get a physician's signature and ID number.

You'll have to schedule a FedEx 2nd Day Air pickup (which is free). Be sure to have the shipping on Monday-Wednesday to make sure it gets to the lab during the business week. I had mine drawn on Wednesday morning with same day pickup.



I'd go with IgeneX over a common lab because they report more band information, including Lyme-vaccine bands. Some band info here. The CDC-recommended ELISA is relatively poor, and the two-tier testing was meant to be for reporting purposes, not diagnostic.

IgeneX will report on a CDC positive, but they also report on their own standard. Not -all- bands will pop positive, as the bands indicate different "parts" of a pathogen, and Lyme will shift surface proteins to evade the immune system.

I think there is also Infectolabs on the other side of the world. There may be other labs, but they seem to be few and far between. If in the States, I'd go with IgeneX.



I'd also test for Lyme co-infections Bartonella, Babesia, Ehrlichia, and Anaplasma.

 

[Alea Ishikawa]

@Esther12 - To my knowledge, the issue was with blood and urine PCRs, but never on the actual Western Blot test. There was also concern on documentation, perhaps that IgeneX reports their own standard, but on my paperwork IgeneX includes CDC requirements, too. If you have something different, please share.

IgeneX letter here. Rebuttal to the NYTimes article here.



On Mayo - they used to be synonymous with some top care, but I've heard some bad news regarding ME/CFS. Perhaps they are better used for other, more mainstream diseases?

 

[duncan]

I have been tested by all the Massachusetts boutiques. I have notched up positives from Imugen and Immunetics. I have done the same with Stony Brook and Mayo. I can say the same about Labcorp and Qwest, and others like BioReference Labs.

I have also spoken with Director levels at each of those labs (well, not Qwest)

The one lab I have never used is IgeneX. But when I had questions about my CSF results from a lumbar puncture that could not adequately be fielded by my clinician, I called IgeneX looking for an out-of-the-box answer. I left a message for a Director to call me. Instead, Nick Harris, CEO of IgeneX, took time out of his evening - TWICE - to talk me through my concerns and confusion. He went into specifics that I never expected. We must have spoken an hour each time, and each time on his dime as he was returning my calls.

He did this knowing I never sent a test or any money his way.

So, for what that's worth, it spoke to a man who cared, and that was a rarity as far as I was concern, and maybe it reflects on the company he built.

 

[Esther12]

@Esther12 - To my knowledge, the issue was with blood and urine PCRs, but never on the actual Western Blot test. There was also concern on documentation, perhaps that IgeneX reports their own standard, but on my paperwork IgeneX includes CDC requirements, too. If you have something different, please share.

That's right. I'm not aware of there having been any double-blind assessment of any of the other IgeneX testing which it is claimed accurately identifies many more people to be suffering from Lyme than any of the other mainstream testing available. That the only assessment done showed their testing [of this sort] was unreliable does not fill me with faith, particularly as we've now had decades of alternative-Lyme doctors claiming Lyme explains the ill-health of a high percentage of those with CFS-like symptoms, and yet being unable to produce good evidence to support their claims. Seems dodgy to me.

[edited following discussion with Ema]

 

[Ema]

You might call it '31kD antigen borrelia specific epitope', just about, but as it is it reads a bit like 'I live in a house small.' I doubt you would get something like this from Mayo because they know that they are providing to people who are familiar with immunology.

From the IgeneX handout on the epitope test:

Principle
Patient serum is incubated with 31kDa recombinant epitope on Western Blot strips. If the 31kDa specific antibody to B. burgdorferi antigen is present, they will bind to the corresponding epitope band.

Hmmm, sounds like picky semantics to me too. Epitope mapping on Western blots where antigen fragments are screened with the antibody are fairly common and simple lab tests.

IgeneX uses it to cut down on false positives, specifically from EBV.

Where's the mislabeled Western blot?

Mayo is completely overrated at this point. Maybe it was good...once. But they are missing things they should be getting (not only the controversial diagnoses) now.

 

[Ema]

That the only assessment done showed their testing was unreliable does not fill me with faith

Not "their testing" as a whole. They have had to prove repeatedly that their testing was valid and reliable to qualify for their laboratory certifications. In fact, I doubt many other labs have been subject to the level of scrutiny in this regard as IgeneX since people are always on a witchhunt.

So, *one* test.

That's it.

One test.

Do you want to call Labcorp and Quest dodgy too because they have at times offered tests found to not be all they said they were? See the CA 125 test which has led to women spending hundreds of thousands of dollars having their bodies carved up looking for cancers that never were. That test is STILL offered at Labcorp et al. Guess they must be dodgy. Not one medical association recommends that test anymore.

They, at one point, used a test that was found to be unreliable. And then took it off their test menu and no longer offer it.

That's actually the way science works.

 

[Esther12]

Not "their testing" as a whole.

But the "IgeneX testing which it is claimed accurately identifies many more people to be suffering from Lyme than any of the other mainstream testing available."

That's the important stuff.

 

[Ema]

But the "IgeneX testing which it is claimed accurately identifies many more people to be suffering from Lyme than any of the other mainstream testing available."

That's the important stuff.

Yes and that part is true.