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» LymeNet Flash » Questions and Discussion » Medical Questions » Igenex testing

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Author Topic: Igenex testing
dian
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My lyme doctor today would NOT order Igenex testing for me even though he is treating me for chronic lyme for four years. My old lyme doctor did do Igenex back in 2005 and it came out positive. My current doctors says " all igenex testing comes out positive" Is this true?
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kareamber
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I have wondered the same thing sometimes. I don't think I've ever seen anyone that didn't show any bands on an Igenex test. But I have seen people that have very few bands.

I'm sure others who have been around longer will have more to comment than I.

--------------------
IgeneX IGG POS 30+ 31++++ 41++
IGM 30+ 31+++ 34IND 41IND 83-93IND
Quest NEG IGG 30 and 41 only

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gemofnj
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no!

my labcorp test was CDC positive in the very beginning. a month or so later i was tested with IGENEX.

it only showed IGM one positive # and one #31 as IND.. (which is a weak positive). but technically, negative. IGG was totally negative.

and there alot of folks here that got negative IGENEX results.

you might want to tell your doc the reason it seems that IGENEX always comes out positive is because it has like 10 -15 bands to run instead of like 5 with the normal lame labcorp and quest.

obviously the more bands, the more results!

Maybe he would rather treat you clinically then spend the money for just a result. If it came out negative, it might affect how you feel about treatment.

[Smile]

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seekhelp
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The million dollar issue. My gut feel after reading this board for a long time is Igenix over diagnosis Lyme, but there's no proof as a healthy population is not tested. It's just opinion and a guess based on likelihood. Others feel much different.
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Leelee
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quote:
Originally posted by dian:
My current doctors says " all igenex testing comes out positive" Is this true?

I don't know if this is true or not, but b/c Igenex testing is so expensive and is not always reimbursable by insurance I don't think many people would take the test if they were not highly likely to have Lyme.

--------------------
The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy. Martin Luther King,Jr

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Lymetoo
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Leelee is right ... except that I don't consider $200 for a high quality Lyme test to be expensive.

My Igenex test was negative.

--------------------
--Lymetutu--
Opinions, not medical advice!

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cherilou57
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I have also wondered about the IGENEX test too. I tested negative but did have 1 + at 2 bands and 2 IND at 2 bands.I am very confused at this point and still trying to figure out what I should do.
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Lymeorsomething
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But then there's the band 31 confirmation test which is purportedly over 97% accurate for lyme. If you have this band, the confirmation may give you more proof theoretically...

My Igenex tests have been similar each time I've run them. So I'd like to believe they are accurate. My band 31 confirmation test was also +.

Keep in mind that cross reactions can happen but supposedly not on all bands.

--------------------
"Whatever can go wrong will go wrong."

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gemofnj
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lyme that is a good point, but his doctor said he doesnt want him to have it.

it doesnt make sense actually. maybe he could insist!

as an alternative, a cd57 could show a low score and thereby proving he does in fact have lyme, and that would be covered by insurance probably.

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Geneal
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I had a Quest WB done.

Not very good, but enough to get me diagnosed by a local doc.

When I saw my LLMD for the first time about 45 days,

He saw no need to repeat Igenex testing.

He concurred with my local doc's diagnosis of Lyme and

Added in Babesia and Bartonella.

He felt it would be a waste of money at that time as

He didn't doubt Lyme was my issue.

Hugs,

Geneal

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pmerv
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In testimony given at the Informational Hearing on Lyme Disease: Issues in Diagnosis and Reporting, Wednesday, February 25, 2004, to the California Legislature Senate Committee on Health and Human Services (Deborah V. Ortiz, Chair) Jyotsna Shah, PhD, CMLD, MBA, Vice President of Research and Development Dept. and Laboratory Director of Clinical Reference Laboratory, IGeneX Inc. of Palo Alto offered the following:


``For the year 2003, just to give you an idea, we had tested 698 patients suspected of Lyme disease. Three hundred and ninety-four were positive by either Western blot or antigen test or PCR. If we had gone by the CDC criteria only, we would have missed 70 percent of this 394 cases.''

In other words, 56% of the Lyme disease tests performed by IGeneX Laboratory in 2003 were positive.

This testimony is on the public record.

At the 2005 ILADS conference, Jyotsna Shah, PhD,CCLD, MBA, said that IGeneX scored better than 95% in the stringent NY proficiency tests from 2001-2005. Out of 58 labs, only IGeneX had a perfect score on Western blot proficiency. In recent tests for 327 patients, 238 were identified as positive by IGeneX criteria. Only 112 would have been correctly diagnosed using the CDC surveillance criteria.

BTW IGeneX tests or any proprietary tests done in house, that are not "kits" sold for commercial use, do NOT require FDA approval.

--------------------
Phyllis Mervine
LymeDisease.org

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Hoosiers51
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seekhelp,

The healthy population has been tested by Igenex I believe. (I'll go find that chart, and I think it was Igenex that did it)

I saw a presentation from Dr. H in CA, and he had a bar graph, showing which bands came up positive and with what frequency, in the general population, vs. the Lyme population.

I will post the presentation here....it has been posted on LN before. The tricky part will be finding the slide it's on, because this presentation had over 100 slides.

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Hoosiers51
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http://www.lymeinducedautism.com/images/Lymewhat_is_it_part_3,_LIA.pdf

The graph I refered to is on slide 78.

If you look at what is on slide 79, it seems to me that they are basing the data on the graph from Igenex testing.

Look at how low the percentages are for the normal population on bands 39 or 23...they appear to be less than 1%. It is unlikely that a normal person would test CDC or Igenex positive based on that data. Testing positive for band 41, however, occurs in about 40% of the population.

But obviously Igenex has researched this, and this is why they do not lable those tests as positive.

I don't know why anyone would assume Igenex hasn't looked into these things, they are certified as a lab by various organizations.

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Leelee
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Hoosiers,

Thank you for the link. I read the entire presentation and found it fascinating.

--------------------
The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy. Martin Luther King,Jr

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dian
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Forall that has posted in response to my question above, thank you very much. I feel that why would people pay out of pocket for these tests if they were not reliable. Many great lyme doctors do use Igenex labs and this is why I questioned my lyme doctor. thanks again for so many postings.
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Lymetoo
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quote:
Originally posted by cherilou57:
[QB] I have also wondered about the IGENEX test too. I tested negative but did have 1 + at 2 bands and 2 IND at 2 bands.I am very confused at this point and still trying to figure out what I should do.

WHICH bands??

--------------------
--Lymetutu--
Opinions, not medical advice!

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cherilou57
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On the IGG: **41 + and 58 +

On the IGM: 18 +, ** 41 +, ** 31 IND and **34 IND

any info or input appreciated

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seekhelp
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Hoosiers51, thanks for the chart. I PMed you. I looked at this again and see the 'normal' controls. Does anyone know what criteria Igenix used to confirm those with Lyme or Syphillis in this graph (positive PCR, clinical Dx, other ideas)? How were normal people excluded from having Bb or syphillis (clinical Dx, negative PCR, other methods)? That's a key question.

If all this data is true, there's very little chance I don't truly have Bb. [Frown] I kind of know this though. It's always nice to wish it away. lol.

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kitty9309
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My IgeneX WB was negative.

I had the bulls eye rash. Swollen knees and vertigo attacks began several weeks later.

That was 1994. I was not treated until Dec. 2008.

All of my Quest ELISA/WB were negative as well.

Have not re-tested yet.

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Hoosiers51
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seekhelp,

I couldn't imagine that they would use "clinical diagnosis" for the Lyme or syphilis groups! It's one thing to use clinical observations in forming a diagnosis, but it would be quite another thing to use clinical diagnosises towards data that is comparing a Lyme population to a normal population.

My guess is that for Lyme they used either PCR, and/or history of CDC positive in the "two tier" approach (positive ELISA followed by CDC positive Western Blot). That is my guess though.

Seems like they couldn't have just used ELISA or just Western Blot, because it would be harder to tell the syphilis group from the Lyme group, since these tests can cross-react to a certain extent.

I'm sure someone could find out, because on slide 79 there were references as to who collected the data.

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seekhelp
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I would guess you're right Hoosiers51. [Smile] I was just curious.
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ChuckG
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I found this about a year ago when I developed an interest in Lyme. Can't believe this site isn't littered with quotes from this article. I refer to it all the time.

IGeneX specificity & sensitivity study

quote:
Comparison of specificity and sensitivity of IGeneX Lyme Western Blots using IGeneX criteria and CDC criteria for a positive Western Blot
Jyotsna S. Shah
Keywords: Lyme disease, Borrelia burgdorferi, Western Blot, tick-borne disease

...Materials and Methods

Source of patient serum samples:

A set of 37 samples (Group 1) was provided by the CDC from patients known to have at least one of the following: EM rash, positive culture for B. burgdorferi, known tick bite, and laboratory-confirmed Lyme disease antibody testing. (16) All the patients were treated for Lyme disease.

... A second group of 45 serum samples (Group 2) consisted of samples positive for other tick-borne infections, including ten positive for Babesia, two positive for Bartonella, and 33 positive for Anaplasma or Ehrlichia. Of these samples, 12 were provided with accompanying patient histories by the proficiency survey agencies, and 33 were collected from specimens submitted to the authors' laboratory for testing for tick-borne diseases in 2005. The latter samples were positive by IFA for non-B. burgdorferi tick-borne diseases with titers equal to or greater than 1:160. Specimens were not included if the proficiency survey agency stated that the sample was from a patient diagnosed with Lyme disease. For patient sera received for testing in-house, only those that were negative for B. burgdorferi antibodies were included in the evaluation.

... A third group of 55 samples (Group 3) was collected from prior proficiency tests from the College of American Pathologists (CAP, Chicago, Illinois) and the New York State Department of Health. All samples were reported as negative for Lyme disease by the survey agencies, and the CAP specimens were reported as negative for other tick-borne diseases. An additional five samples were provided by the CDC as negative controls, for a total of 60 negative samples.

... In summary, based on data presented on Lyme disease samples collected over a 13-year period, specimens from other tick-borne diseases and from normal controls from endemic areas, we recommend that the criteria for a positive IgM and IgG WB should include bands 23-25, 31, 34, 39, 41, and 83-93 kDa, with at least two of the six bands being present. (Antibodies to bands 31 and 34 kDa should not be considered in vaccinated patients for evaluation of disease.) The data further indicates that IgM antibodies to Lyme antigens can be found at all stages of Lyme disease, and thus a positive WB by IGeneX criteria only suggests exposure to B. burgdorferi.

Corresponding Author

Jyotsna S. Shah, PhD


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seekhelp
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THANK YOU ChuckG for the great information!!! I've wondered.

This phrase makes me wonder: 'and thus a positive WB by IGeneX criteria only suggests exposure to B. burgdorferi.' So a CDC IgM positive means nothing w/o a positive PCR or actual spirokete found in one's tissues/blood? LLMDs use this test and consider it good as gold in a final Dx.

I wonder if the negatives by NY and CDC standards (guessing not tested initially by Igenix) remained negative under Igenix whether CDC-negative or Igenix negative or hopefully BOTH.

The flip side shouldn't be concerning as Igenix obviously is much more likely to produce a positive than other labs since they report so many more bands. I'd like to see the outcome of each group. For example:

- Group A: 37 CDC positives reported by XYZ translated to x CDC positives under Igenix and y Igenix positives according to their internal standards.

- Group B: Same info

- Group C: Same info

Know what I mean? I hope the group A plus group B individuals remained positive under Igenix and group C (60 negatives) for the most part did too. if group C didn't, did the 60 negatives convert to 40 positives under Igenix? Most importantly, did Igenix use the same test standards under this controlled study used day-to-day for consumer testing? Did they toss out IND readings? I wish the sample size was 1,000 or 5,000, not 130-140.

A firm bringing in as much business as Igenix could probably test 1,000 healthy individuals as an experiment (pay them $10-$20 for blood) as a bigger control. If I owned this lab, I would conduct a bigger control base to give my lab further credibility. Maybe more ID docs would use Igenix and PCPs would view them less discriminantly as well? This generation of new business could offset the lab's minor expense incurred to test more healthy individuals.

The logic of the testing sounds very well-thought out. I am no scientist obviously. Does a lab or study need a minimum number of participants/subjects for a study to be considered credible for Medicare/FDA purposes?

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ChuckG
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seekhelp
I believe you did not read the whole report. The link is (stupid site software should colorize URL links in posts) "IGeneX specificity & sensitivity study" underlined in my previous post".

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seekhelp
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Chuck, I don't know how I so stupidly missed your link! I just read it thoroughly. I must make a public apology for my ignorance here after reading the level of detail provided. It answered exactly what I needed to know.

If us consumers are being tested EXACTLY the same way specimens were tested during the audit, I feel more comfortable. I heard rumors Igenix was more stringent during their audit, but this is a rumor only. I have no idea one way or the other.

Yep, I'd love to have seen the study be a 1,000 or 5,000 control group instead of 130-160, but.....you do with what you're dealt. [Smile]

With my Igenix WB results, it's sure hard to think Bb isn't the cause of many issues. Then the ultimate question, does exposure to this organism really cause ALL these symptoms or are other things manifesting? Unfortunately, this will never be answered if the bacteria can't be cultured.

I'm just not intelligent/scientifically-minded enough to comprehend how world-class scientists can't locate this thing in people's bodies. How sneaky can it really be?

Also, I assume the two strains Igenix looks for are virulent ones?

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Pinelady
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Consider that all other labs do not test for the other possible stains -It makes sense.

They think it is better to call one wrong than to call themselves inadequate.

As for testing now it may be more favorable to quest on a CD test.


http://www.personalconsult.com/articles/mastersdisease_stari.html


Master's Disease or "STARI"

Master's Disease (aka STARI) was described in the early 1990's by Dr. Ed Masters of Cape Girardeau, MO, when a number of people were bitten by lone star ticks and developed Lyme disease symptoms. Many patients had a classic rash, nearly identical to the one described in people infected with the more well known strain of Lyme, however, the standard Lyme disease tests were not able to detect evidence of the infection in humans.

Recently DNA from a strain of spirochete similar to the one that causes Lyme disease was detected in lone star ticks collected from nine different states, according to the US Army Center for Health Promotion and Preventive Medicine in Aberdeen, MD. Borrelia lonestari, or STARI (Southern Tick Associated Rash Illness), the nick name used to describe this strain, was also detected in the blood of white tail deer, in Sika deer skin samples, and in ticks removed from wild raccoons. In 2004, visualization of live lonestari spirochetes were reported for the first time by researchers at the University of Georgia using dark field microscopy.

According to the CDC, a skin biopsy from a rash resembling the one that can appear in Lyme disease patients was tested for the Borrelia lonestari. The patient reportedly had exposure to ticks in Maryland and North Carolina. The biopsy of the Lyme-like rash, along with the tick that was removed from the patient, both showed evidence of the lonestari strain. Standard blood tests for Lyme disease again failed to detect the presence of infection from this strain of Lyme disease.

People who have been told they do not have Lyme disease and/or who were denied treatment based on negative blood tests should be re-evaluated by an experienced physician if they remain ill, have fluctuating symptoms, or develop additional symptoms. Anyone who has been denied treatment because the tick that bit them was not a "deer tick" may want to take a closer look for the source of any ongoing or worsening symptoms they may be experiencing.

Lone star ticks are able to transmit STARI to humans, as well as a number of other tick borne diseases, such as Erhlichiosis (various strains), Rocky Mountain Spotted Fever, Tularemia (rabbit fever), and possibly additional, yet to be discovered, bacteria and viruses. Some of these infections can become chronic or fatal if not promptly or properly treated.

Lone star ticks, Amblyomma americanum, have been found in approximately half of the states in the US. They have also been collected from migrating birds returning to Canada from southern locations. The ticks current known range in the US extends from Texas to Oklahoma, eastward towards the Atlantic coast, and northward to Maine. These ticks are extremely aggressive and actively search for blood meals. Residents from areas with high tick populations have reported removing over 100 of these ticks after a single outing.

Adult lone star ticks are larger than deer ticks, however, the nymph stage ticks can be as small as the period at the end of this sentence. A light colored patch, or star, is displayed on the back of adult female ticks, giving the tick their common name.

Ticks infected with STARI have been found just outside major city limits, posing risks to rural residents and city dwellers alike. Cardinals, wrens, sparrows, woodpeckers, brown thrashers, wild turkeys, bobwhite quails, and other birds are known to transport ticks from site to site. Raccoons, opossum, fox, squirrels, rabbits, mice, and deer are also hosts to this species of tick and provide necessary blood meals during their various stages of growth.

People infected with STARI may develop the rash that may also be seen in approximately 50 percent of the patients who have the more well known strain of Lyme disease. Other STARI symptoms can include fatigue, headaches, possible fever, muscle aches, stiff neck, and joint pains. Untreated or under treated STARI has not yet been documented by the CDC to cause the same debilitating effects found in chronic Lyme disease patients with the similar strain, however, research is ongoing and by no means, complete. The International Lyme and Associated Disease Society (ILADS), has noted in the past, "surveillance studies show that these patients [seronegative] may have a similar risk of developing persistent, recurrent, and refractory Lyme disease compared with the seropositive population."

The CDC has recently been requesting samples of blood, urine, and skin biopsies from suspected STARI patients in order to study this specific strain. Unfortunately, the current standard Lyme disease tests on the market were not developed to detect evidence of infection from a variety of strains of spirochetes found in ticks. As experienced physicians know, these standard tests are very limited in their ability to aid in a proper clinical diagnosis of tick borne diseases. The discovery of this specific strain of Lyme may help explain why ILADS has noted that up to 90 percent of people with Lyme disease are being missed using the current two-tier testing procedures. This outdated testing method is still recommended by the Centers for Disease Control, the Territorial Public Health Laboratory Directors, and was approved by the Food and Drug Administration for use as a diagnostic tool, however they warn that negative tests are not to be used to rule out Lyme disease.

According to Dr. Nick Harris, the Western Blot and PCR Lyme tests developed for use at IGeneX Lab in California are broad enough to be able to detect various Borrelia strains across the US, rather than just one single strain. "IGeneX tests are sensitive to the lonestari variety of Borrelia, as well as burgdorferi," explains Harris. Patients with various strains of Lyme have been detected in a number of states. IGeneX Lab offers testing for other tick borne infections such as Babesiosis, Erhlichiosis, and Bartonella.

Lyme disease is the fastest growing infectious disease in the nation. The CDC and state health departments admit considerable underreporting of Lyme disease, with as many as 7-12 cases being missed for each one reported in some states.

A knowledgeable doctor, use of a high quality lab for testing, and a proper tick borne disease diagnosis and treatment would be especially important to people in endemic areas who continue to have fluctuating or relapsing symptoms and/or have developed late stage neurological, arthritic, psychological, or other related Lyme disease symptoms. Untreated or improperly treated Lyme disease (Borrelia burgdorferi) can become a devastating chronic illness that can severely affect individuals, as well as entire families.

Late stage or chronic Lyme disease symptoms can mimic other diseases such as Parkinson's, Alzheimers, MS, Lou Gehrigs (ALS), depression, arthritis, Scleroderma, Lupus, heart problems, chronic fatigue syndrome, Fibromyalgia, ADD, panic attacks, pain syndromes, thyroid disorders, or other conditions.

--------------------
Suspected Lyme 07 Test neg One band migrating in IgG region
unable to identify.Igenex Jan.09IFA titer 1:40 IND
IgM neg pos
31 +++ 34 IND 39 IND 41 IND 83-93 +
DX:Neuroborreliosis

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ChuckG
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quote:
Also, I assume the two strains Igenix looks for are virulent ones?
Why would a lab test for a non-virulent strain? If or when more strains are found to be virulent they will be added to the test(s). There is a lot of interesting research on nonvirulent strains.

I am curious. Do you have your CDC negative band numbers? Have you compared the individual band results with the information in the IGeneX study?

quote:
For IgG antibodies, the 12 bands varied in their association with B. burgdorferi infection. Bands 23-25, 34, 39, and 83-93 kDa were highly significant markers for infection compared to both Groups 2 and 3. Band 31 kDa was rarely detected in patients within the first year of Lyme disease diagnosis. However, it was present in 87.5% of patient serum collected between one year and 13 years after initial diagnosis of Lyme disease--and was a highly significant marker for infection in this late Lyme patient group as compared to both Groups 2 and 3.

So if you have, say, two of the IgG bands I have bolded above then you most likely (not a very scientific term, of course!) have Lyme. Why two and not just one? The more bands the less likely tis a false positive.
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seekhelp
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Chuck, I've got quite a few markers on my WB:

IgM: 23-25+++, 31+, 34+, 41 IND, 58+

IgG: 23-25 IND, 31 IND, 39 IND, 41++, 45+, 58+, 83-93+

This was my second Igenix test after being on Abx therapy for 6 months.

Not sure what to make of all the INDs. I always see so many 'so close to CDC+' Igenix tests, but oooh just a + off. [Smile] Regardless, it's pretty bad results for me.

The article makes it sound like STARI strain isn't much of an issue. By deduction, I must have this one as LabCorp and another commercial labs couldn't pick up anything more than a 41+ IgG band. It's not logical Igenix found all these mystery bands if I have Bb and two labs test for the same strain (especially on the IgG side where the major CDC bands are consistent between labs).

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TerryK
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One thing I want to mention:

"Sensitivity" means the ability of the test to detect patients who have the disease.

"Specificity" means the ability of the test to exclude those who don't.

Usually, an increase in one of these measures means a decrease in the other.

The CDC designed their test criteria with high specificity as a goal because they are using the results for surveillance purposes whereas patients need a test with high sensitivity so that patients who need treatment won't be missed.

It makes no sense to insist that a patient cannot possibly have lyme disease unless they are CDC positive. The CDC criteria was not designed to catch all patients with lyme disease. They and the IDSA fully admit this. It is designed to make sure that no one who is counted in the official numbers is a false positive.

That said, one can have absolutely NO borrelia specific bands and still be CDC positive. That should tell you how whacko their criteria is.

Terry

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bettyg
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chuck and pinelady,

will you both break up your long posts of special info you each found into SHORT paragraphs and double space so we can comprehend this GOOD INFO? i just can't read it let more comprehend it .... other neuro lyme folks will enjoy this as well.

thank you both for your consideration! [Smile] hugs

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Leelee
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TerryK,

Thank you for the easy to understand explanation.

--------------------
The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy. Martin Luther King,Jr

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Pinelady
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Sorry Betty. My point was I don't believe my

first blood work included some strains and this

could be why I was first neg. then Pos. While

data on lab testing post treatment is sketchy at

best for us. This data is as overdue as quality testing.

http://www.personalconsult.com/articles/mastersdisease_stari.html

The CDC has recently been requesting samples of blood, urine, and skin biopsies from suspected

STARI patients in order to study this specific strain. Unfortunately, the current standard Lyme

disease tests on the market were not developed to detect evidence of infection from a variety of

strains of spirochetes found in ticks. As experienced physicians know, these standard tests

are very limited in their ability to aid in a proper clinical diagnosis of tick borne diseases.

The discovery of this specific strain of Lyme may help explain why ILADS has noted that up to 90

percent of people with Lyme disease are being missed using the current two-tier testing

procedures. This outdated testing method is still recommended by the Centers for Disease Control,

the Territorial Public Health Laboratory Directors, and was approved by the Food and Drug

Administration for use as a diagnostic tool, however they warn that negative tests are not to

be used to rule out Lyme disease.

According to Dr. Nick Harris, the Western Blot and PCR Lyme tests developed for use at IGeneX

Lab in California are broad enough to be able to detect various Borrelia strains across the US,

rather than just one single strain. "IGeneX tests are sensitive to the lonestari variety of

Borrelia, as well as burgdorferi," explains Harris. Patients with various strains of Lyme

have been detected in a number of states. IGeneX Lab offers testing for other tick borne

infections such as Babesiosis, Erhlichiosis, and Bartonella.

Lyme disease is the fastest growing infectious disease in the nation. The CDC and state health

departments admit considerable underreporting of Lyme disease, with as many as 7-12 cases being

missed for each one reported in some states.

A knowledgeable doctor, use of a high quality lab for testing, and a proper tick borne disease

diagnosis and treatment would be especially important to people in endemic areas who continue

to have fluctuating or relapsing symptoms and/or have developed late stage neurological,

arthritic, psychological, or other related Lyme disease symptoms. Untreated or improperly treated

Lyme disease (Borrelia burgdorferi) can become a devastating chronic illness that can severely

affect individuals, as well as entire families.

--------------------
Suspected Lyme 07 Test neg One band migrating in IgG region
unable to identify.Igenex Jan.09IFA titer 1:40 IND
IgM neg pos
31 +++ 34 IND 39 IND 41 IND 83-93 +
DX:Neuroborreliosis

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