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

duncan

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At this point, their use of 2 strains is great self-marketi
I thought you thought this had nothing to do with markets and marketing and competition and such,and only science?

Anyone have any idea when the new IDSA Lyme Guidelines are due out? I would be very much surprised if this study is not cited.

I encourage you to reach out to IgeneX with any questions. As for me, any data points that help me I will embrace. It's ultimitaley about the information you as a patient can glean. I wish you luck in that endeavor.
 
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@duncan - To repeat, this post is about the Brian Fallon's study, Igenex and the false positive rate found in the study.

Specificity can be tested, and measured. It is science -- statistics!

I am not interested in the marketing, competition dynamics, politics, or conspiracy theories. There are plenty of threads on this.

If you have evidence/information that Igenex has improved their methodologies or interpretation criteria in response to the findings of Fallon's study -- then please share.
 
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duncan

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If you have evidence/information that Igenex has improved their methodologies or interpretation criteria in response to the findings of Fallon's study -- then please share.
Check out another reference to the austinpublishinggroup pdf file on Lymenet Europe dated Jan 30 2015 and entitled "IgeneX Changes Interpretation Criteria For Positive Serology."
 

duncan

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It somehow appears they think it is appropriate to retest the samples at this stage (which it is not!) and it appears they are now using "revised interpretation criteria and recombinant antigen WB" to come up with another self-proclaimed specificity rate
Clearly, @cyclist , you read in their 2015 response that they have "revised interpretation criteria." The Stricker IgeneX letter, which you referenced, also states the new specificity to be 91.7%. So I am confused as to why you would ask if there are any indications of a revision to criteria.

What may also interest readers here is the letter also points out that according to the Fallon study, the two-tier sensitivity in Lyme patients who remained sick following treatment was only at 48.6%, while Specialty LabB (supposedly IgeneX) had a sensitivity of 89%. As you likely know, @cyclist , sensitivity and specificity are an essential tandem.

But again, as I have repeatedly suggested, the Lyme community could only benefit if improved diagnostics were pursued by all concerns.
 
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duncan

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I have been looking for this exact information! I've been wanting to know if it's possible to be exposed to borrelia, create antibodies to it, but have never developed any symptoms of Lyme. Seems it is indeed. It's from the Lyme & Tick-Borne Diseases Research Center at Columbia University.
I agree with you. BTW, I go to this website a lot, or at least I used to. I find their definition of disease somewhat curious, though: "...the definition of disease requires symptoms." If someone has early cancer and is without symptoms because the cancer has not progressed to a point where symptoms manifest, does that mean that person doesn't have the cancer until symptoms present?

On a more TBD-related note, what about babesia, which I've been told can lay silent within a patient even after treatment - and can appear subsequently, even after years of apparent dormancy - did that person not have the disease until symptoms presented?

(Sorry for the thread sidetrack. This is actually related to the thread in a round-about way, as this is Fallon's back yard...)
 
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valentinelynx

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@valentinelynx - I responded, see post #22.
OK, I see your response. Unfortunately, I can't evaluate these claims right now. I do agree with the general problem, however, that there is an urgent need for highly sensitive and specific tests for borrelia infection, and not just the one strain (or even two) that are testable for in the US currently.
 

TrixieStix

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I agree with you. BTW, I go to this website a lot, or at least I used to. I find their definition of disease somewhat curious, though: "...the definition of disease requires symptoms." If someone has early cancer and is without symptoms because the cancer has not progressed to a point where symptoms manifest, does that mean that person doesn't have the cancer until symptoms present?
It doesn't seem any different to me than when people get infected with a flu virus, and never get sick. The only way they would know they were exposed/infected is if their blood was examined for antibodies. The term "Flu" is only used to denote when a person becomes symptomatic from the infection. I see the use of Lyme disease as being essential the same.

https://www.eecs.umich.edu/eecs/about/articles/2011/hero-flu.html
 

duncan

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It doesn't seem any different to me than when people get infected with a flu virus, and never get sick. The only way they would know they were exposed/infected is if their blood was examined for antibodies. The term "Flu" is only used to denote when a person becomes symptomatic from the infection. I see the use of Lyme disease as being essential the same.
Fair point. I tested positive for babesia antibodies, but was not really symptomatic. I spoke with a leading babesia expert who essentially said the same, and his advice to me was don't treat - but not because I wasn't infected --- it was more along the lines of let sleeping dogs lie. At the same time, he warned me that the parasite could cause havoc some day down the line (of course, he said that might be true even WITH treatment).

With Lyme, it becomes even muddier, potentially, at least in some schools of thought. If you test positive for Lyme and are asymptomatic, do you leave it alone? There are cogent arguments on both sides.
 
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Late stage/chronic Lyme patients often are not making enough antibodies though, right?

40 is kind of a small sample, too....
Daff. not only that but I think that when dealing with long term Lyme, the immune system does not continuously and steadily mount a defense against the Lyme pathogen(s). It's too metabolically costly to do this long term. I think the immune system will have periods when it rests and recoups its energy, and time when it mounts a massive defense. This is easily observed in the body when with long term infectious processes, one 's state of health and sickness goes up and down alot. (it's your activated immune system that really causes symptoms). It does not remain steady. If the moment blood is drawn to test for Lyme, and the body's immune system is being more dormant, it might not show up on the test. Obviously this is just my own theory, but I think it plausible.
 

Daffodil

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Daff. not only that but I think that when dealing with long term Lyme, the immune system does not continuously and steadily mount a defense against the Lyme pathogen(s). It's too metabolically costly to do this long term. I think the immune system will have periods when it rests and recoups its energy, and time when it mounts a massive defense. This is easily observed in the body when with long term infectious processes, one 's state of health and sickness goes up and down alot. (it's your activated immune system that really causes symptoms). It does not remain steady. If the moment blood is drawn to test for Lyme, and the body's immune system is being more dormant, it might not show up on the test. Obviously this is just my own theory, but I think it plausible.
but that would cause a false negative..not a false positive
 
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What may also interest readers here is the letter also points out that according to the Fallon study, the two-tier sensitivity in Lyme patients who remained sick following treatment was only at 48.6%, while Specialty LabB (supposedly IgeneX) had a sensitivity of 89%.
This is unequivocally false. The Fallon study was NOT designed to infer sensitivity -- and the authors specifically state this. The Lyme patients have already been treated with antibiotic therapy, some having extended courses, and there are several plausible theories for ongoing symptoms, autoimmune reactions, other infections, viral reactivation, ect.

The fact that in the wake of such damning data (false positives), Igenex continues to shamelessly self promote -- and inappropriately so -- makes their response all the more disturbing.
 

duncan

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The Lyme patients have already been treated with antibiotic therapy, some having extended courses, and there are several plausible theories for ongoing symptoms, autoimmune reactions, other infections, viral reactivation, ect.
...

....continued Lyme infection...
 
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It doesn't seem any different to me than when people get infected with a flu virus, and never get sick. The only way they would know they were exposed/infected is if their blood was examined for antibodies. The term "Flu" is only used to denote when a person becomes symptomatic from the infection. I see the use of Lyme disease as being essential the same.

https://www.eecs.umich.edu/eecs/about/articles/2011/hero-flu.html
Thanks for this links! I agree. I was told that nearly the entire population has been exposed to Epstein Bar Virus by the time they reach adulthood, and yet only subset of folks actually get Mono. I have IgG for EBV but never had mono either.
 
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...

....continued Lyme infection...
That is one of many! And because patients have already been treated, and their are multiple plausible explanations for persistent symptoms, this study can not infer sensitivity. This is explicitly stated in the paper. So the statement you're referencing - is false. Period.
 
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Arguably the most likely one. :)
"Arguably" - key word. And it appears to be highly argued.

And, if Igenex changed their criteria or methodology to reduce their false positives, then they should use their new methods (whatever that is ?!??) to calculate the new positivity rate (a positivity rate, not a sensitivity rate), AND they didn't even do that. The igenex response is garbage in so many ways. There is a reason it wasn't published and they had to resort to the "pubmed commons" section.
 

Belbyr

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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