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Igenex testing, what's the deal?


#5

I had some positive bands on the IGM and the IGG but my overall results said negative, my naturopath called the a igenex doctor and she said it was negative but I should do a urine test. I can’t afford another test!! I already gave them over a 1000.00$ . I don’t know what to think anymore. I was having symptoms of fibro for over 2 years now , my friend convinced me to get a Lyme test and now I’m more confused then ever.


#6

Unless you tested positive for Lyme through either the Western Blot or ELISA tests, you do not have Lyme disease. The IGeneX testing is not an accurate indicator of Lyme disease…never has been, which is why you have had to seek care out of pocket. I would seek care for the fibromyalgia, as that is what you were diagnosed with by a real doctor. Run from any provider that offers Lyme diagnosis and treatment based on an igenex test.



Maggie999 said:

I had some positive bands on the IGM and the IGG but my overall results said negative, my naturopath called the a igenex doctor and she said it was negative but I should do a urine test. I can’t afford another test!! I already gave them over a 1000.00$ . I don’t know what to think anymore. I was having symptoms of fibro for over 2 years now , my friend convinced me to get a Lyme test and now I’m more confused then ever.

#7

GrumpyCat, I thought that the igenex was a western blot? So confused. What is the IGM and IGG.


#8

Igg and Igm are immunoglobin. They are not specific to lyme. western blot is a tecnique.


#9

Tj1, why does it say Igenex western blot IGM and IGG?? Sorry for all the questions


#10

They are testing immunoglobin just as the traditional "western blot" does (its a sorting technique) specific "antibodies attach to different proteins. Igenex has decided that some antibodies are indicative if lyme that no one else does. They don't have the evidence and no one else has been able to confirm their theory(s) either.

Our immunoglobin contains antibodies for every bug, virus, etc that we have ever been exposed to or our mothers, or our grandmothers. Most of them are not diseases we have ever had. Our immune system fights of millions/billions of intruders every day. Many if not most of these antibodies are not disease specific. But through research we find some connections. The science is called immunology. Sometimes we get really lucky most time we don't. WE were able to stop ebola, there actually exists vaccines for lyme, (politics and the vaxers stopped them) and immunology controls HIV. It certainly is no where as simple as IGENEX makes it out to be. The additional bands they use for lyme have never been directly correlated to ACTIVE disease. In fact they market their test as "experimental" and leave the interpretation up to the quacks that use it.

Here is an explanation of the procedure: (its been around for many many years)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3456489/


#11

Okay, so now I'm getting even more worried and confused. If my doctor is a "quack" I need to know before I go on his detoxing (herxing) because I know I will get sicker and now I think it might just be how he makes people think it's working. I had the Western Blot Lyme test from Quest and tested reactive to Band 23. The test itself says I needed more than one band to have Lyme, but the doctor says band 23 is specific and so it's either there or it's not. I asked if I should retest in case it was a false positive. I didn't get a good answer to that question. HOWEVER, I do believe his diagnosis that I have mold toxicity as I KNOW there is mold at my workplace and I have had trouble with mold throughout my life, including a bout with asthma due to black mold in an apartment in 2002. I know my immune system is crashed, I have stress, and I'm 46 and have hormonal stuff going on. This lyme connection is what is confusing and then the testing for all these various co infections. My CD57 test was low.........he says that shows my immune system is down. I have no vitamin D or testosterone. I believe all that. And my biotoxin c4a test was high.....15,064 which from what I read says I'm fighting something, probably the mold. Other people have quit the job due to mold affecting them. So those things I KNOW. What has thrown me is this lyme thing and then being afraid of parasites and bacteria...........we all have bacteria! I am VERY sick with odd symptoms and when I read the lyme symptoms they do fit. But I do not know of ANY tick bite. The doctor says I probably had it for 20 years. Can you PLEASE guide me if I'm being led down a bad path or if the blood test is definitive. Also, you and GrumpyCat say to beware the Lyme Literate doctors, but others on this support group support what I have read. Are all the books about lyme, etc. not true? What supports your opinions? I'm just trying to get educated so I make good choices. This all so new to me.


#12

I understand your frustration. I myself have done a lot of research and can not find anything definitive. It’s all very confusing. Let me know if you find some answers.i hope someone else can help you with this question, if you don’t get any replies start a new post


#13

The "Lyme Literate Doctors" haven't made any of them well. If in fact you read the stories, most of them are sicker.andmoving to the next treatment (so long as their credit cards aren't maxed yet) medical books real medical books that are peer reviewed are not sold by non scientists or on Amazon. I call it the OZ effect. Finally his peers have had enough, removed hi and censured him and yet he keeps blithering on. There is not one honest goodness study done in an academic center that supports any of it. There is a conspiracy but its not the world wide scientific community.

That is not denying you or any here are not sick. Some may actually have had lyme disease (I did and frankly it was worse than the Hong Kong Flu. All of that aside One think almost everyone has in common is a damaged immune system. What damaged it is irrelevant. There may be evidence left behind (antibodies) but that evidence is neither the damage nor the illness. If I throw a rock through the living room window, and bust it, Throwing the rock back through it doesn't fix it..... If eliminate the rock laying on the floor and all the broken pieces of glass, The window IS still broken.

The broken window needs fixed. What needs done is symptoms need treatment. Not the rock taken out of the living room


#14

What is so frustrating is that there is a huge popuation profiting on people who are just trying to get good information. You all want to be looking at sites that support the conventional diagnosis and treatment of Lyme disease and RUN from all the resst. That "herx" reaction that your alternative "medicine doctor" wants you to have is actually your body reacting to an overdose of antibiotics. They want to poison you. The only medicine that should make you feel worsse before making you better is chemo.

Everyone has to remember that just because it's published, does not make it true. Just because it's written by a supposed doctor, does not mean that they are still a respected member of the mmedical community.


#15

I find this very interesting… Part of me agrees with you, GrumpyCat. The part that has been suffering for the past year (when I’ve been blessed to never really have suffered before :slight_smile: and diagnosed with neurological Lyme does not. My diagnoses were made on some postiive bands on both of the Igenix tests, a brain MRI showing one area of FLAIR, and clinical symptoms. I don’t know who to listen to or believe anymore. Normally, I tap right into my gut and move forward. Something is clearly wrong with my brain, however. As a professor, this really sucks. I haven’t been able to work in any meaningful way in the year.

I feel taken and cannot believe that people who are so vulnerable and now without money, have to keep dishing out money in a desperate attempt to feel well again. This must change.


#16

Lyme is a clinical diagnosis and should not be based solely on lab results. We all know that Lyme causes immune system dysfunction. So, how can you rely on antibodies alone for a diagnosis? Also, WB and ELISA do not tell you if you have a current or past infection. The two-tiered testing is SEVERELY flawed. A negative Lyme test does NOT mean you do not have Lyme.


#17

The herx reaction I feel is the same when off antibiotics as when I am on antibiotics. The herx is ACTUALLY worse when I’m off antibiotics. If I stop my treatment at all, I begin to feel much, much worse. The ones who are profiting are the doctors, pharmaceutical companies and the labs - I spent THOUSANDS of dollars over YEARS with my conventional doctor and never, ever felt any better. Within two weeks of seeing my naturopath LLMD, I felt better than I had in years. She actually addressed my body’s NEEDS instead of covering them up with prescription pills. My naturopath wants to poison me? lol. She’s actually doing the opposite, by helping me kill bacteria, flush it out and nurture my body. My PCP diagnosed me with things like CFS and fibro - those are NOT a diagnosis. They are a symptom of a much bigger problem that she was not willing to address or help me overcome!


#18

I hope you have found some help since 2015! People are skeptical of LLMDs because they use alternative medicine. We are all taught to trust doctors and if the docs say to beware of naturopaths, we are supposed to believe them. Well, I never felt any better with my PCP. Within two weeks of seeing a LLMD, I felt SO MUCH BETTER. I am finally treating Lyme, detoxing with herbals, using the right supplements and building up my immune system. I don’t know why people are going around trying to scare us. There is nothing wrong with natural medicine. My doc uses both western and eastern. They BOTH have benefits. Good luck to you!


#19

Rebecca, Welcome to the Lyme Disease community. One of the things that you will notice here is that the focus of this community – and all Ben’s Friends communities – is conventional medicine and evidence-based treatments. It’s wonderful that you’ve experienced improvement from the treatments you’ve received from your naturopath, but we regard such treatments as complementary therapy, and we will routinely caution our members that such therapies are in addition to conventional medicine, not a replacement for it. There are other communities and forums who take a different approach, but this is ours.

I’m wondering if I could ask you, please, to introduce yourself to your fellow members by adding a summary of your Lyme experience to your profile so that people will have an idea of what you’ve gone through. (I’m sure everyone here will wholeheartedly agree with your comment that Lyme Disease sucks, but that doesn’t tell much about you.) Having new members share a bit about their disease history makes it easier for other members to relate, and it contributes to an atmosphere of openness. The way to add to your profile is this:

  1. Click on your avatar near the top right of the page.
  2. Click on the gear icon
  3. Select “profile” from the list on the left
  4. Make your additions and changes
  5. Scroll to the bottom and save your changes.

Thanks for completing your profile as soon as possible!

Seenie from Moderator Support


#20

The most common diagnostic tests for Lyme disease are the ELISA and the Western blot. The CDC recommends that the ELISA is ordered first, and this is considered a form of epidemiological screening. Then, to confirm Lyme disease, a Western blot is run. In theory, this sounds great but, in reality, both tests are measuring the patient’s antibody response to the infection, not the infection itself. That may work for other diseases such as HIV, but not so well with Lyme. In the beginning stage of the Lyme infection (the crucial stage to diagnose), most people have not yet developed the antibody response that the test measures. The organism may not even be in the bloodstream . Lyme bacteria is known for for its stealth activity, and likes to hide and trick the immune system. So with all the hiding from, and hijacking of, the immune system measuring the patient’s antibody response to the infection seems to be one of the reasons why there are so many negative test results. The ELISA being the first test ordered and considered a form of screening is in my opinion unreliable. The test has a 65% sensitivity, and that is unacceptable as the first step of a two-step screening protocol. By definition, a screening test should have at least a 95% sensitivity. The ELISA test was designed as a surveillance monitoring tool for the CDC to track the number of Lyme disease cases throughout the country. It was not meant to be used in making a diagnosis. Many doctors have dismissed the possibility of Lyme disease when their patients have a negative ELISA result and choose not to perform the Western blot.
The Western blot is the second test ordered to confirm the ELISA screening test. If the patient has an antibody to a specific protein, a “band” will form at a particular place on the Western blot. If the blot has bands in the right places, and the right number of bands, then the test is positive for Lyme. The problem I see with this test not being accurate is that the CDC removed two vital bands, 31-OspA and 34-OspB from this test. These two bands are highly specific bands for diagnosing Lyme. With the bands removed, this makes an accurate diagnosis extremely difficult. OspA and OspB proteins of Borrelia burgdorferi, are considered to be among the most species-specific proteins of the organism, and yet they have been removed. Igenex automatically reports all bands.


#21

And I would highly caution anyone seeing a doctor who contends that the standard CDC protocol is a perfectly sufficient diagnostic metric for Lyme. Of the 3 bands looked at for IgM Western blots, band 41 is widely cross-reactive, 39 is cross-reactive among all spirochetes, and only band 23 (Outer surface protein C/OspC) is Borrelia-specific. Outer surface proteins B and C, two of the most widely studied Lyme antigens, are completely excluded. Further complicating matters is that fact that OspC is a widely variable protein, so much so that the literature groups strains by their “OspC type.” Almost all labs use strain B31 as the source of their antigens for ELISA and Western blot tests, which is an OspC type A strain. The problem is that OspC types B, I, K, and to a lesser extent H, are also widely prevalent and proven to cause infection (source 1, table 1). Antibody cross-reactivity studies have shown devastatingly low levels of cross-reactivity between OspC type A and the other types (source 2, table S3), especially K, which is the most common type in the Northeast (includes strain 297). This means that by the CDC protocol, if you are infected with an OspC type K strain, your band 23 that would have made you CDC positive could come back negative, and you might go untreated.

I am all for skepticism regarding the LLMDs and specialty labs, but as someone with a biology degree and several years of molecular biology/microbiology research experience, some of the “science” I have seen from the conventional doctors and government agencies regarding Lyme is borderline disgraceful, and is at a minimum a violation of basic scientific thought and logic.

Sources:

  1. Brisson D, Baxamusa N, Schwartz I, Wormser GP (2011) Biodiversity of Borrelia burgdorferi Strains in Tissues of Lyme Disease Patients. PLoS ONE 6(8):
    e22926. doi:10.1371/journal.pone.0022926
  2. Baum E, Randall AZ, Zeller M, Barbour AG (2013) Inferring Epitopes of a Polymorphic Antigen Amidst Broadly Cross-Reactive Antibodies Using Protein
    Microarrays: A Study of OspC Proteins of Borrelia burgdorferi. PLoS ONE 8(6): e67445. doi:10.1371/journal.pone.0067445

#22

31-OspA and 34-OspB

In the 1996 serology conference (I was there and along with my colleague Willy Bugrdorfer who was one of the primary presenters. There was agreement that the use of OspA and OspB (31-and 34-kDa) bands did not significantly add to the sensitivity or the specificity of the IgG Western blot (The western blot is what Igenex does - its a technique not a specific test), as these bands may develop only late in disease and other diagnostic bands would already be present when OspA and OspB antibodies appeared.

The concern was that the elimination of these bands (OspA and OspB) from the diagnostic criteria might result in excluding some cases of Lyme disease.

WeThe conference reviewed the data for all patients who had positive ELISAs and immunoblot assays for Lyme disease from 1 September 1992 to 31 December 1993 in order to assess whether any patients considered to have Lyme disease by the previously used criteria would now be considered negative according to these new recommendations.Of the 136 patients who were evaluated for suspected Lyme disease during that time period, 50 were considered to have Lyme disease. Of these 50, 4 patients would not have met Western blot criteria for the diagnosis of Lyme disease by the new recommendations. Quite the opposite effect actually. But that is left out in "independent testing. Granted 136 patients is on the low end of what would be considered a strong statistical base

The numbers a better for the current method The recommendations by the CDC/ASTPHLD are based on data by Dressler et al., who prospectively evaluated 225 case and control subjects.
They concluded that the following bands were considered helpful in the diagnosis of Lyme disease: 18, 21, 28, 30, 39, 41, 45, 58, 66, and 93 kDa. The reported sensitivity and specificity of the IgG blot after first weeks of infection were 83 and 95%, respectively. In the world of serology those are significant numbers. (and no where close to 65%.

There was another interesting thing brought out in the conference and interestingly enough brought up by Eileen Hilton, james Devoti and Sunlil Sood from Long Island Jewish Medical Center who were proposing the addition of 31-OspA and 34-OspB and that was that Currently, the most common problem in diagnosing Lyme is the over diagnosis of Lyme disease, and the development of standardized criteria for the serological diagnosis of Lyme disease is a welcome improvement.

I’m not saying that there isn’t room for evaluating the whole serological basis of Lyme diagnoses, but then serology has NEVER been an absolute measure of anything.

My problem with “specialty labs” is not necessarily the data they produce, My problem is LLMDs and their use of the data. Pouring antibiotics into folks based on the data is the problem. Is malpractice (if not criminal) pure and simple. Herxing for example, they say is a good thing when it is body reacting to poison and trying to right itself. Its a very serious situation.

According to Serological Testing I have measles, mumps, chicken pox, and polio and even Hong Kong flu. Some of those things I have had some I have not, but I have been exposed to all and will have positive bands if a blot is done. Doesn’t mean I need treated for any of them.

What these guys fail to do is understand is that serology simply is determining whether or not the immune system has responded to a stimuli. That response varies, so there is a lot more to diagnosing a condition than just a “blood test”

Huge differences in antibody responses of patients with Lyme borreliosis have been noted; European investigators have reported IgG bands of 22, 41, and 60 kDa in patients with meningitis and 13, 18, 21, 23, 30, 39, 60, 73, and 94 kDa in later stages of infection. Patients in the United States, while similar in their IgM responses (21 and 41 kDa), showed reactivity to greater numbers of spirochetal polypeptides including,
in addition to those above, the 28-, 31-, 34-, 45-, 58-, 66-, and 74-kDa proteins. In other studies from the United States, 71% of 80 patients with arthritis had strong IgG reactivity with OspA (31 kDa) or OspB (34 kDa) or both and have never been exposed to Lyme.

Antibiotics can treat active infections effectively. They can’t treat an infection that has run its course and the immune system has handled in some manner already.

So all of that to say IGENEX, so what. There is a huge reason they provide only Data not diagnoses. but the biggest problem is patients are not being properly treated as a result. Lyme when not treated EARLY can lead horrible disease OUTCOME and permanent Damage. Its is incorrectly called chronic lyme Disease 9only my the “Lyme Literate” The real problem is “Post-treatment Lyme Disease Syndrome” (PTLDS). That varies by the individual and needs treated for what is going on, not what caused it. Lyme has already done its damage. Keep in mind Lyme Spirochetes are gram-negative, motile, spiral bacteria that are antibiotic resistent. The more antibiotics you give them the stronger they get and the less able the body is to fight them.

So yes a good doctor will treat SYPMTOMs not a lab test. If that happens to be reactive Arthritis (the most common outcome) FMS, or other rheumatological symptoms, thats what needs treated. The best one can hope for from “testing” is confirmation that “yup,something is going on…”

TJ


#23

Wow, you were a colleague of Dr. Willy Burgdorfer. Another moderator went fishing with him. I guess you would both know that Dr. Willy Burgdorfer stated–
'The controversy in Lyme disease research is a shameful affair. And I say that because the whole thing is politically tainted. Money goes to people who have, for the past 30 years, produced the same thing—nothing. There are lots of physicians around who wouldn’t touch a Lyme disease patient. They tell the nurse, “You tell the guy to get out of here. I don’t want to see him.” That is shameful. So [this] shame includes physicians who don’t even have the courage to tell a patient, “You have Lyme disease and I don’t know anything about it."
OspA and OspB (31-and 34-kDa) bands Were taking out of the Western blot due to greed over a failed Lyme vaccine.

In the early 90’s, Allen Steere described Lyme Disease as a disease that affects the brain causing a mass amount of systemic issues.
https://www.nytimes.com/1990/11/22/news/lyme-disease-shows-latent-effects.html
CDC decided to make a vaccine for Lyme Disease. 1992 Allen Steere decided to go to Europe and change the entire definition of Lyme Disease. In order to promote the new Lyme vaccine. CDC officers U, Yale, Corixa and Imugen all own patents.
Dearborn conference in 1994, Steere and others claimed Chronic Lyme no longer exist a new definition was made. This is just a part of the hidden truth about a 75 billion dollar disease called Lyme.


#24

Understand that vaccines are most frequently not immunization but rather a treatment. (A common misunderstanding about “vaccines” The original patent in this area was from Ribi immunochem an independent research/development Montana company that interestingly enough is/was right across the street from the CDC Rocky Mountain Laboratory (RML is is best known as the “Tick Lab” around here. It was prolly one of the most successful projects to ever come out of the labs.

Recombinant vaccines didn’t do much for Lyme because Allen Steere was right in one respect . The problem isn’t Lyme as most people fully recover(about 90%) but rather the damage to both the body and immune system Lyme causes in the other 10%. That damage isn’t disease but rather the result of a disease that in some measure that group has recovered from. The Lymies have never distinguished the difference between active “Lyme Infection” and post infection syndromes. Its an important distinction wwhich has lead to unwarranted and unfounded attacks on Alan Steere and Barbara Johnson.

Recombinant vaccines pioneered at RML and Willy’s work have done more for treatment of multiple diseases than any single approach in recent years. Other “names” for them include “Gene Therapy,” Immunotherapy and “biologic Medications” Multiple forms of cancer (especially childhood cancers), HIV, most Recently Ebola Diseases once thought non treatable are now treatable. Death rates from childhood cancers have dropped from 80% to less than 20% in the past few years along with some forms of prostate, breast cancer and Multiple Myeloma. Millions of Arthritis patients now have a life as a result. The field is FINALLy emerging after nearly 70 years going back to of all things Rocky Mountain Spotted Fever research.

OspA and OspB (31-and 34-kDa) bands were not taken out of the Western blot due to greed over a failed Lyme vaccine. quite the opposite in fact. Willy and others understood that by including them, fewer patients would be treated. OspA and OspB (31-and 34-kDa) bands indicate (as near as anyone can tell) advanced disease damage including them in the “Western Blot” which is a diagnostic INDICATOR (not a pass fail test) would in the way things work preclude treatment for many who had negative OspA and OspB (31-and 34-kDa) bands.

It doesn’t mean the bands shouldn’t be done and the data isn’t important, it just means that they should NOT be a part of a screening/diagnostic protocol looking for active (and highly treatable) disease.

Here’s the problem as I see it. You are correct the disease is political. It hasn’t become that way because of the CDC, but rather by patients who are demanding treatment/cure. The whole process then falls into the hands of borderline charlatans who meet that demand with unproven/often dangerous treatments who take advantage of these folks. The basis of all of this is "we know what we are doing and the medical/pharmacology industries don’t and don’t want to. There is a long list of these diseases/conditions.

On a personal Note Lymrix is perfect example of disease politics gone arwy. It was designed as a three-dose medicine, studies showed the vaccine was 49 to 68 percent effective at preventing Lyme disease with two injections. After the third and final injection, that number jumped to 76 to 92 percent effective. The studies were done by multiple independent sources who had no financial stake in the thing.

In 1999, a class action lawsuit was filed against the drug company by 121 people who had received the vaccine and had developed arthritis. They claimed the vaccine caused harmful side effects and that the pharmaceutical company was hiding the evidence.

Around the same time, an infamous study in the journal Lancet connected another type of vaccine with autism. Today, that Lancet autism study has been retracted and proven false, but it helped fuel an anti-vaccine movement that still persists

In April of 2002, the company announced that sales for LYMErix had fallen from 1.5 million doses in 1999 to about 10,000 expected for that year. That was despite the fact that cases of Lyme diseases were on the rise. The company stopped producing and selling the vaccine that year.

After the company pulled the vaccine, the U.S. Food and Drug Administration (FDA) conducted several additional tests to verify or refute the lawsuit’s claims. They were unable to replicate the adverse events and side effects that opponents of the vaccine reported in the lawsuit and elsewhere.

The company settled the class action suit based on economic concerns for a product showing poor performance in the market. The final agreement included $1 million in legal fees but provided no financial compensation to the supposed vaccine victims.

Despite it still being approved and licensed in the United States and despite studies to refute the claims of side effects, Glaxo SmithKline has never reintroduced LYMErix.

It had nothing to do with The Dearborne conference, definitions, or the like. and everything to do with activism.