Study finds Igenex has a 57.5% FALSE positive rate - I'm horrified!

duncan

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Hey, @cyclist: This was 2014. It's history. If you are concerned about how IgeneX's sensitivity and specificity stack up today, then check out their website. Better yet, call them.

I find it encouraging that the company reportedly took steps to modify its approach after the Fallon study. Has the 2T changed its protocol in the face of all the criticism hurled its way since, I dunno, say the turn of the millenium?

Personally, I think this can be interpreted as Science unfolding as it should: Taking corrective measures when appropriate.
 
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I'm going to be calling them tomorrow to see if their 'new parameters' still means I'm positive on my test from 2007
Great! Can you ask exactly what the changes are, and when they happened? From the article posted by @TrixieStix - it seems it's based on the band 31 confirmation testing and interpretation changes for Band 83-93...but I'm not sure. Would be so great if you could report back!
 
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Hey, @cyclist: This was 2014. It's history. If you are concerned about how IgeneX's sensitivity and specificity stack up today, then check out their website. Better yet, call them.
I've already called them and they were not helpful at all - in fact, downright rude.

I've had it with the "history" - if this is "old news" to you, then move on to another thread.
 
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Personally, I think this can be interpreted as Science unfolding as it should: Taking corrective measures when appropriate.
The "science" that you're referring to wasn't even published in a journal that is indexed by PubMed. In order for a journal to be included, it needs to meet PMC's scientific quality standard. Why can't Igenex publish in a real journal?!
 
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But, I suppose that Chronic Diseases International is a step up from the only other time Igenex has "published" their test sensitivity (in 2007)-- in the Townsend Letter.

http://connection.ebscohost.com/c/a...x-criteria-cdc-criteria-positive-western-blot

Here's what wikipedia has to say about the Townsend Letter

https://en.wikipedia.org/wiki/Townsend_Letter

...We encourage reports which frequently are not data-based but are anecdotal. Hence, information presented may not be proven or factually correct.

...The website Quackwatch has listed the Townsend Letter on its list of magazines as non-recommended and fundamentally flawed.

The more I look into this, the more sick to my stomach I get....
 

TrixieStix

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@cyclist

Thought you might want to read this. It is 1 part of a 9 part blog series this woman did about Lyme. This post is specifically about the Fallon Igenex study we are discussing. She herself has MCAS (not Lyme) and is an Infectious Disease Microbiologist interested in studying various disease science. Her conclusion in part 9 of her Lyme posts finds her concluding that both sides of the Lyme debate are wrong about thing and that the truth lies somewhere in between.

http://www.mastattack.org/2015/02/lyme-disease-chronic-lyme-part-6/

http://www.mastattack.org/2015/02/lyme-disease-idsa-ilads-and-my-conclusions-part-9/
 

Belbyr

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I called Igenex and they said that my test from 2007 if for sure out of date. (They actually don't even have mine archived anymore)

The one I spoke with said they HAVE changed diagnostic criteria and testing procedures. The only way for me to know for sure would be to spend another $1,000 on new testing. :confused:
 
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I called Igenex and they said that my test from 2007 if for sure out of date. (They actually don't even have mine archived anymore)

The one I spoke with said they HAVE changed diagnostic criteria and testing procedures. The only way for me to know for sure would be to spend another $1,000 on new testing. :confused:
@Belbyr - I appreciate your reporting back. And I'm sorry they weren't more helpful...
 
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@cyclist

Thought you might want to read this. It is 1 part of a 9 part blog series this woman did about Lyme. This post is specifically about the Fallon Igenex study we are discussing. She herself has MCAS (not Lyme) and is an Infectious Disease Microbiologist interested in studying various disease science. Her conclusion in part 9 of her Lyme posts finds her concluding that both sides of the Lyme debate are wrong about thing and that the truth lies somewhere in between.

http://www.mastattack.org/2015/02/lyme-disease-chronic-lyme-part-6/

http://www.mastattack.org/2015/02/lyme-disease-idsa-ilads-and-my-conclusions-part-9/
@TrixieStix, These are great links, thank you for sharing! I also think the truth is somewhere in between. But it's nearly impossible to find balanced commentary and objective, critical thinking on the matter.
 
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Great! Can you ask exactly what the changes are, and when they happened? From the article posted by @TrixieStix - it seems it's based on the band 31 confirmation testing and interpretation changes for Band 83-93...but I'm not sure. Would be so great if you could report back!
It appears the Band 31 confirmation test is not new, and has been around since 2008.
http://www.lymeneteurope.org/forum/...sid=d2c18fe851b5054339d74ec9f70ac511&start=10
http://www.lymeneteurope.org/forum/viewtopic.php?f=6&t=5794

And "LymeorSomething" also posted about band 31 confirmation test back in 2009
http://flash.lymenet.org/scripts/ultimatebb.cgi?ubb=get_topic;f=1;t=083307;p=0

I think it's still unclear what changes Igenex made in their retesting to get from 23 false positives down to 2.
 

TrixieStix

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@cyclist Wanted to let you know that I just got the results of my standard lab (Quest) Lyme western blot test and I am "CDC positive" for IGM and negative for IGG. Also one of the 2 IGM bands that made me CDC positive is one that did not show up as positive on my Igenex test.

Also the same IGG band that showed up on my Igenex test also came up positive on my standard test.

So in my case the Igenex test was less sensitive than the standard Lyme test in that my Igenex test was "CDC negative" for both IGM and IGG.

Ultimately I would like to repeat the standard western blot and see if I again test CDC positive for IGM or not, but not sure insurance would cover it. Wonder what the cost is?

I also do NOT plan to undergo any treatment for Lyme based solely on a positive IGM test until I learn more about the research touted as proving Epitope Switching or Anitgenic Variation can happen with b. Burgdorferi and that it is happening a lot. And that this explanation makes more sense than the current explanation for high rate of false positivity of IGM lyme immunoblot testing.
 
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TrixieStix

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@cyclist this is in reference to standard Lyme IGM immunoblot testing. As I suspected it states that not much research into this issue has been done.

High frequency of false positive IgM immunoblots for Borrelia burgdorferi in clinical practice


https://www.ncbi.nlm.nih.gov/pubmed/22369185

"False-positive IgM immunoblots are common in clinical practice and appear to reflect both over-reading of weak bands (of which only 2 are required by IgM interpretation criteria) and the greater cross-reactivity and bindingstrength of IgM antibodies."

http://www.vpta.org/downloads/Downl...ourseReading/Lymes Disease Misperceptions.pdf
 
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I continued to research this. I have spoken with several ILADS physicians -- and there appears to be NO reasonable explanation for this high false positive rate. It is ludicrous to believe that nearly 60% of the normal, healthy population in upstate NY (where the controls were supposedly sampled) is walking around with undiagnosed lyme disease...and yet that is what one doctor suggested!

And none of the doctors I spoke with suggested that Igenex changed is methodologies or interpretation criteria in response to this study. I could not find any documentation of this. The publication that people are referencing doesn't indicate this -- and the 31 Kda epitope confirmation test was already in place at the time of the Fallon study.

Please don't take my word for it. Research it yourself. Ask your own doctors.....

And to those that contributed to the thread, providing helpful and informative links, and/or sharing personal experience -- many, many thanks!
 
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