posted
Just curious as to what makes Igenex testing more superior to than of any other lab i.e. quest, labcorp, mdl?? My neuro NP said all the blood they send to Igenex come back positive...but can't say whether people really are positive or not...I'm just wondering if their technology is different than the other labs and in what way?? that said I did order my kit from Igenex 3 days ago....
Posts: 145 | From NorthEast US | Registered: Aug 2005
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posted
i'm not a scientist,but... one possiblile reason for why igenex gets so many positives.
one can test negative because antigens are tied up in immune complexes. the antigen, being bound to an immune complex is therefore not free to bind with antigen-detection agent(s) a lab uses to detect antigens.
a lab will therefore use lab technique(s) to breakup the immune complex to free the antigen once again. once free, the lab will then add a borrelial antigen detection agent to the mix, and use further testing to detect any of their antigen detection agent that bonded to the borrelial antigen.
i don't know if igenex breaks up immune complexes, at some point in time during processing of specimens, but if they did, this would be reason for testing anti-body positive for borrelia.
an excellent start for some of the problems(not inclusive) with testing are here: http://www.actionlyme.com
there are too many reasons to list here.
there are at least two lists of reasons for testing negative on a western blot test antibody test.
Posts: 2708 | Registered: Feb 2005
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AZURE WISH
Frequent Contributor (1K+ posts)
Member # 804
posted
I think but I am not positive (long time since I been tested and memory is not always accurate)
that igenex tests for a couple extra bands that I believe are more specific to lyme.
But I could be wrong.... it certainly wouldnt be the first time.
posted
Yes their test is different, it was designed to be effective in all stages of Lyme not just early Lyme like most labs. They used samples that came from patients at Yale and a hospital in Old Lyme. The samples taken were not just early lyme but mid-lyme and late lyme. This is surely one of the reasons why they have more positve results
Also, instead of one strain they used two to make the blot strips, more bands represented.
If you are getting the whole packet and not just the test forms there will be alot of information to read about all the tests and how they are differernt, more sensitive.
Posts: 465 | From New York, NY | Registered: Aug 2005
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lymednva
Frequent Contributor (1K+ posts)
Member # 9098
posted
Even with Igenex we don't all test positive.
I know that my body has not produced significant amounts of antibodies since at least the mid-70's. It was then that I had my first Rubella vaccination because I knew I had never had Rubella, I worked with young children, and I was planning to start a family in a few years.
When I did become pregnant I showed no immunity to Rubella, so I had another vaccination after my first child was born.
When I became pregnant with my second child, I was seeing a different doctor. Again I did not show immunity to Rubella, so after my second child was born I had another Rubella vaccination (yes, that was #3!).
By my third pregnancy my doctor decided that perhaps I had immunity, just not enough to show on the titer, so no more vaccinations.
I'm sure I would not show immunity to it today either. Luckily I am not planning any more pregnancies. I'm also pretty sure this is why I have not tested positive for Lyme yet.
At least my doctor has not been afraid to treat me anyway.
-------------------- Lymednva Posts: 2407 | From over the river and through the woods | Registered: Apr 2006
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
Good question, Kumba. It's good to be informed.
One really good reason is that they test for two key bands that almost every other lab in the country omits. Those bands on the western blot are so important, so SPECIFIC to lyme disease only, that they used them to make the failed lyme vaccine from.
Another really good reason why IGeneX is superior:
That's all they do.
Tick disease testing.
No wonder they're so good at it.
They don't do the bazillion other tests done by all the other labs. They concentrate on one thing and one thing only.
Here's what a noted doctor has to say about them: (snipped from CanLyme - thanks Canadians!) ____________________________________ Tick Specialty Labs: Too Many Positive Findings?
They Save Lives
By James S., MD, MAR, PA, DABPN, DABFM
I asked Dr. Harris, from the internationally respected, IGeneX labs, to reply to the dubious comment that IGeneX "only has positive findings."
This is not valid for many reasons. First, many physicians using IGeneX get negative results. Further, IGenex has done quality assurance studies with appropriate negative findings in uninfected controls. And the company, as you can see below, has done a great deal to be certified and licensed.
The "all results are positive comment" is lazy, sloppy and uninformed. Lyme is the leading vector illness in the USA. A positive result should not be rare.
*********
IGeneX, Inc. is a reference laboratory located in Palo Alto, California specializing in Lyme disease and other tick-borne diseases. We take pride in the quality and diversity of the testing that we perform on samples from around the world.
IGeneX is licensed by CMS (Centers for Medicare and Medicaid Services) and is strictly regulated by CLIA. We are licensed in all states, including California, New York, Pennsylvania, Maryland, and Florida where special licensing is required. The laboratory is inspected by these state and federal agencies on a regular basis. A Ph.D. consultant is also used to ensure that our laboratory is current with all the compliance regulations.
IGeneX participates in all proficiency programs required, such as New York State. Independent specialty laboratories, such as IGeneX, who have a narrow focus in testing, typically are not certified by CAP, but we do participate in the CAP Proficiency programs.
IGeneX has been testing clinical samples for over 11 years. The staff consists of a Laboratory Director, an MD Clinical Consultant, and several other MDs who also are licensed Clinical Laboratory Scientists who manufacture and perform tests. The personnel responsible for the test quality and performance are all licensed Clinical Laboratory Scientists, most of whom have been with IGeneX for many years. Our Research team is comprised of qualified PhDs and MDs and experienced Research Associates.
Customer Service is our main goal and the office staff is always willing to assist our patients and physicians. We take pride in our trained personnel that have worked together for years. IGeneX is continually working on the advancement of existing tests. In addition, IGeneX is committed to designing and researching new technologies and opportunities. Our goal is to give Lyme patients and their physicians state-of-the-art tools for diagnosis of Lyme and other tick-related diseases. --------------
[Steve Andison Comment] The Federal Center for Disease Control periodically ships identified samples of what they know to be positive and negative samples to IGeneX to determine the accuracy of their testing procedures. Their accuracy rate for both positives and negatives is unsurpassed by any facility in the United States and with their state-of-the-art techniques and equipment, they may be the most accurate lab for diseases carried by ticks.Posts: 3193 | From Northern California | Registered: Apr 2005
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posted
I think it is important to express that all Igenex Western Blots do not come back positive. We have had three family members and all the tests were Negative--by both CDC and Igenex standards.
Having said that, all of our Western Blots did indicate some very lyme specific bands.
Posts: 554 | From Naples, Italy | Registered: Jun 2006
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posted
I agree that IGeneX doesn't always come back positive.
All three of us here were CDC and IGeneX negative, but because of our symptoms, the endemic nature of Lyme where we live and some indeterminate (IND) findings on Bb specific bands, we are all being treated.
-------------------- Getting older is when we would rather not have a good time than have to get over it. - Oscar Wilde Posts: 386 | From Radnor, PA - where the ticks run free | Registered: May 2006
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
Thanks for adding that, Sojourner and Penn - since I know lots of posters don't have positive IGeneX tests.
Here's one other thing to keep in mind, Kumba, when pondering why they seem to have a lot of positives:
Most people who send in blood to be tested have already presented themselves to an LLMD for treatment and been at least clinically diagnosed with lyme, or their LLMD has a strong suspicion they have lyme.
It's not as if people on the street were sending in blood.
These are people who already have a history and symptoms consistent with lyme. So when you look at it that way it doesn't really seem too unusual.
It's kind of like if your neuro told you, "Man, it's mighty weird how that cancer specialty lab keeps finding high cancer markers in those cancer patients! They must be a bogus lab!"
That comparison is not that far off the mark.
The lyme-illiterates have been trying to take down IGeneX for a long time. So believe me, they've been subjected to more probably ten times more scrutiny than any lab around. They've come out shining.
When ducks make statements like this, it only demonstrates ignorance. Fight ignorance with knowledge!
Glad you are getting the tests done.
Michelle
Posts: 3193 | From Northern California | Registered: Apr 2005
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posted
thank you everyone..interesting. I thought the same...its only people who are presenting with sx that are sending samples to Igenex. Why is Igenex not considered the premier lab by the medical community?? I understand insurance companies dont want to pay...and are powerful influences. But why cant Igenex be recognized as acceptable as any other lab? dont they do some kind of accuracy/quality control like all the other labs?? What is the hold up??
Posts: 145 | From NorthEast US | Registered: Aug 2005
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posted
"Why is Igenex not considered the premier lab by the medical community??"
Well igenex seems to find lyme in everyone,but cant get an approved test?? Why is that
If there test is so acccurate get some CDC officials down there and show them. It will never be a premier lab until then. By sitting back collecting test money,they are not helping the lyme community.
Lyme will not be recognized till there is a test. What happen to that test Dr. P from CT was going to come out with years ago?
Posts: 40 | From CT | Registered: Oct 2006
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5dana8
Frequent Contributor (1K+ posts)
Member # 7935
posted
Igenex reads all the bands.
Although igenex is one of the very best labs Lyme still should be a clinical diagnosis, based on patient history & symptoms. And some tests to exclude other diseases like lupus.
Here are many reasons you can still have lyme & test negative:
-------------------- 5dana8 Posts: 4432 | From some where over the rainbow | Registered: Sep 2005
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
quote:Originally posted by griff:
Well igenex seems to find lyme in everyone,but cant get an approved test?? Why is that
If there test is so acccurate get some CDC officials down there and show them. It will never be a premier lab until then. By sitting back collecting test money,they are not helping the lyme community.
Griff, what are you talking about?
Have you been following the conversation?
...The part where people are describing their negative tests from IGeneX?
And what do you mean by they 'can't get an approved test' -- ?
Not only are they "approved," but in fact, Medicare pays for IGeneX testing, so if you're a Medicare recipient you don't have to pay up front.
They've actually gotten more certifications than they need!
They don't just "sit back and collect test money." They actually care about the lyme community and are also a research facility, always working to develop new tests with better sensitivity.
Why don't you read their website, to get an idea of exactly what they do and the diverse kinds of tickborne disease testing they offer?
But let me help you first about their certifications.
*************
IGeneX, Inc. is a specialty immunology laboratory and research facility, providing personalized service to over 1,000 private practice physicians, hospitals, and other clinical reference laboratories throughout the U.S. and Canada. The laboratory also functions as a pilot site for diagnostic manufacturers in the introduction of new assays, and has extensive collaborative agreements with multiple research groups.
The Reference Laboratory, founded in 1983, was purchased from 3M Diagnostic Systems (3MDS-Santa Clara, CA and BioWhittaker, Inc., Walkersville, MD) in 1991 by IGeneX, Inc. and moved to Palo Alto, California.
The laboratory is CLIA-certified, inspected by the Department of Health and Human Services for Medicare testing, and is also licensed in those states with special requirements (California, Florida, Maryland, New York, and Pennsylvania). The attached letter lists our certifications, validation protocols, and quality assurance practices.
Personnel include MDs, PhDs, and California licensed and nationally certified clinical laboratory scientists (medical technologists); research, accounting, and marketing staffs; and client service specialists. Directing the staff is Jyotsna S. Shah, PhD, CCLD, MBA; Clinical Consultant: Steven J. Harris, MD; and Nick S. Harris, PhD, AMBLI, President. A letter from the President:
Our staff of professionals, who have worked together for many years, is committed to the following practices, ideals, and procedures:
* State-of-the-art testing methodology; * Rapid turn-around-time; * Dedication to personalized testing; * Willingness and availability to answer your diagnostic questions; * Ongoing refinement of existing tests; and, * Research and development for innovative quality tests to enhance your diagnostic tools.
Nick S. Harris, Ph.D., ABMLI President, IGeneX, Inc. Laboratory Certifications CLIA 05D0643914 Medicare ZZZ32759Z CA State Dept of Health CLF4033 FL State Dept of Health 800002892 MD State Dept of Health 885 NY State Dept of Health 3172-805133A0 PA State Dept of Health 025659 Posts: 3193 | From Northern California | Registered: Apr 2005
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By DAN HURLEY and SANTORA&fdq=19960101&td=sysdate&sort=newest&ac=MARC SANTORA&inline=nyt-per>MARC SANTORA
Steve Courcier just wanted to know: did he have Lyme disease or didn't he?
Doctors who tested Mr. Courcier in March at the Mayo Clinic in Scottsdale, Ariz., ruled out Lyme, a tick-borne illness, as an explanation for the disabling pain and exhaustion he was suffering. Then a Texas doctor sent his blood sample to a California laboratory that indicated he did have Lyme disease. But a New York specialist who tested his blood a third time, in June, said emphatically that he did not.
"It's amazing to me that you could have this much disparity in medical test results and not have the government do something," said Mr. Courcier, 38-year-old executive with a consulting firm who lives with his wife and two young children in a Dallas suburb.
Now the New York State Department of Health has opened an investigation of the California laboratory, IGeneX Inc., that issued Mr. Courcier's positive result, after receiving eight complaints from doctors and patients who said its Lyme tests also gave them positive results not confirmed by other labs' results.
Concern about Lyme testing goes beyond New York State. This year the Food and Drug Administration and the Centers for Disease Control and Prevention released a warning about Lyme tests "whose accuracy and clinical usefulness have not been adequately established."
The warning did not mention IGeneX or any other lab by name. But Dr. Paul Mead, a C.D.C. scientist who helped write it, said in a telephone interview, "Quite simply, we're concerned that patients are being misdiagnosed through the use of inaccurate laboratory tests." He added that some of the tests and techniques used by IGeneX were among those the agencies were concerned about.
Nick Harris, the founder and chief executive of IGeneX, defended his company's testing, saying that the federal guidelines miss many patients who have Lyme disease.
Guidelines from the disease control agency recommend Lyme testing only when patients have symptoms and live in an area of the United States where ticks are known to be infected with Borrelia burgdorferi, the organism that causes the disease. Under the guidelines, laboratories should first conduct a test called Elisa. But the Elisa test often gives a false positive result, so the agency also calls for a second, more sensitive test, the Western blot.
The recent warning by the two federal agencies named some tests they said had not proved useful or accurate. They noted, for instance, that some laboratories performed a test called polymerase chain reaction "on inappropriate specimens such as blood and urine." IGeneX offers such tests on both blood and urine. The alert also warned against methods of interpreting Western blots "that have not been validated and published in peer-reviewed scientific literature."
Nationally, reported cases of Lyme disease have more than doubled in a decade, to at least 23,963 in 2003 (the most recent year for which statistics are available) from fewer than 9,000 in 1993. Infectious disease experts agree that infections have been on the rise, but they worry that part the increase may be due to overdiagnosis.
A misdiagnosis can have serious consequences. In some cases, Dr. Mead said, Lou Gehrig's disease was misdiagnosed as Lyme by unproved tests. The patients in those cases, he said, wasted thousands of dollars on ineffective treatment. The antibiotics used to treat Lyme disease can also cause complications, including severe allergic reactions.
Some doctors and patients, however, have a different concern. They believe Lyme is often missed by the traditional tests recommended in C.D.C. guidelines.
Dr. Harris, of IGeneX, estimated that his laboratory tested 50,000 to 75,000 patients each year. (Prices go up to $390 for a battery of tests it recommends.) "These are patients who have been bounced around," he said. "A lot of them were undertreated at some time, and their disease came back."
Still, he went on, IGeneX runs the traditional tests accurately and gives doctors guidelines for interpreting them both by the C.D.C.'s conservative standard and by IGeneX's more liberal standard - even though he asserted that the conservative standard would miss many cases of chronic Lyme infection.
He provided a reporter with a document showing that in each year since 2000, IGeneX had achieved scores of at least 97 percent accuracy on the Western blot and Elisa tests, well above the minimum 80 percent required by the state.
But Robert Kenny, a spokesman for the State Department of Health, said the agency was not convinced that IGeneX was performing the recommended tests for the public in the same manner as it has been performing them to pass the state's proficiency review.
Moreover, Mr. Kenny said IGeneX had not supplied requested proof that its urine antigen test can be used to accurately diagnose Lyme disease.
Dr. Harris says IGeneX has been working for more than two years to supply New York State with the proof it wants. "It's been an exceedingly long process that's nearing completion," he said. Dr. Mead at the C.D.C. also confirmed that another laboratory, Bowen Research and Training Institute Inc. of Tarpon Springs, Fla., went beyond the agency's recommended tests.
The State of Florida denied its application last year for a license to perform tests meant to diagnose Lyme, but its founder and president, Dr. JoAnne Whitaker, asserts that the tests it continues to perform are for research purposes only.
Some patients insist that IGeneX's tests have been instrumental in detecting the Lyme disease that other laboratories missed. One such patient is Ronald Hamlen, 64, a plant biologist from Maryland who worked at DuPont for 22 years before retiring recently. Tests run by IGeneX, he said, detected Lyme disease that was missed by other laboratories.
"If I had not had the positive result at IGeneX, I seriously question whether I would have been alive at this point," he said in a telephone interview. Before getting tested by IGeneX and going on intravenous antibiotics for 10 weeks, he said, "all I could do at that point was lie on the couch."
In contrast, Mr. Courcier's odyssey into the Lyme testing labyrinth began last year on the Sunday after Thanksgiving, when a severe pain in his leg led him to seek care at a walk-in clinic. Preliminary diagnoses of phlebitis and muscle strain proved inaccurate, and as the pain increased and spread, he finally went to the Mayo Clinic.
Doctors there told him that an initial test for Lyme disease came back negative, but they could offer no other clear diagnosis for what was ailing him.
Back home in Texas, Mr. Courcier was referred to a neurologist specializing in Lyme disease. The neurologist sent samples of his blood to IGeneX, as well as to Quest Diagnostics, one of the country's largest medical testing companies. Each lab followed the two-step process recommended by the C.D.C.
IGeneX and Quest Diagnostics performed the Elisa and the Western blot tests on Mr. Courcier's samples. The Elisa came back positive from both labs, suggesting that Mr. Courcier might have antibodies to B. burgdorferi.
On the Western blot tests, however, IGeneX sent back positive results, while the Quest testing came back negative.
Although his doctor started him on antibiotics to treat the possible infection, Mr. Courcier was encouraged by a colleague to visit Dr. Gary Wormser, chief of the division of infectious diseases at New York Medical College in Valhalla, for another opinion. Dr. Wormser repeated the Western blot test and told him in June that he did not have Lyme disease.
At first, Mr. Courcier did not know whom to trust, and he remained on the antibiotics therapy prescribed by his doctor in Texas. But by July he concluded that he did not have Lyme disease and stopped taking the antibiotics, which he said were only making him feel worse.
"It's been a hell of an emotional roller coaster," said Mr. Courcier, who conceded that it was a comfort for a while to have a definite explanation for the pain and exhaustion that continue to plague him.
Dr. Mead of the C.D.C. said he sympathized with Mr. Courcier's plight. But for now, he said, patients and physicians should rely on the recommended two-step process. The tests, he said, are accurate in more than 90 percent of cases of long-term Lyme infection.
But he added that he was still troubled by the dispute. "We don't want to be absolutely dogmatic that it's our way or the highway," he said. "At the same time, it's clear there are tests out there for which there is really precious little to support their accuracy."
Posts: 40 | From CT | Registered: Oct 2006
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posted
Hi Kumba I have also asked myself the same questions. Which result can we trust? The best answer I found was from a LLMD. Sorry, I don't know the reference. Perhaps someone here can find it.
He presented his data at a conference back in the 90's. Basically, he found that 99% of a series of 700 consecutive pts with +ve WB from Igenex responded to treatment.
Essentially then, a positive Igenex WB predicts who is going to improve on abx. Getting better is the end point. A negative WB suggests that pt is less likely to improve but because seronegative lyme disease exists, it's still possible.
Chiz
Posts: 67 | From UK | Registered: Oct 2006
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
Thanks, Griff! I think this article is a glowing recommendation for IGeneX! 97% proficiency -- well above the required 80%. Can't get much better than that!
It's true that some of their tests aren't accepted in many circles -- the LUAT, for example.
However, one needn't order tests that aren't yet widely accepted. Order a western blot. You can't get much more basic than that.
Oh, wait a minute. No -- let's use a lab instead that just skips band 31 and band 34 entirely, the most specific bands there ARE for lyme disease!
Yeah. That's a good idea!
Michelle
Posts: 3193 | From Northern California | Registered: Apr 2005
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posted
Thank you all. Its good to hear everyones perspective. I guess my bottom line and probably that of many others here...is that when you've gone form doc to doc, specialist to specialist and have no dx and feel like your knocking on deaths door, your life, physically, emotionally, financially, socially has been turned upside down...a trial of longterm antibiotics no matter what your tests results are...seems like a prudent decison. at least for me.
Posts: 145 | From NorthEast US | Registered: Aug 2005
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posted
Poor guy's probably walking around with Lyme Disease. He had a positive IgeneX and Quest Elisa followed by an IgeneX positve WB. He stops antibiotcs because he feels worse on them? Too bad nobody was around to tell him it was a herx. What's the followup on this guy who had disabling pain and exhaustion? They convinced him that he didn't have lyme and diagnosed him with what???
How many stories of people being misdagnosed by Mayo Clinic?
Posts: 465 | From New York, NY | Registered: Aug 2005
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bettyg
Unregistered
posted
Griff, it would be helpful if you had the date of that article listed; same w/Michelle of Canlyme's excellent info you posted. I added that to my newbie links/advise.
Kumba, my husband had a FEW positives but not enough to be called positive! Me...positive plus on both!
local clinic took blood again and sent it to MAYO CLINIC, ROCHESTER,MINN; would you believe they tested only 2 of 16 and 5 of 16 protein bands; calling me NEGATIVE FOR LYME! They lost their prestegious name in my book after their MISDX!
good discussion though! Thanks for asking for others to learn including this 2+ yr. member!
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posted
Exactly. I guess no one ever explained what a herx was to him. I have had three people go to Mayo in Rochester. They were all told that they didn't have Lyme. The two adults were given appointments with a psychiatrist. They couldn't leave until they had this appointment. They basically just laughed in their faces. I always try to talk people out of going there, but sometimes people have to find out for themselves. They always call me afterwards to tell me I was right. Maybe this guy will finally realize that he has LYME!!!!!
quote:Originally posted by MarsyNY: Poor guy's probably walking around with Lyme Disease. He had a positive IgeneX and Quest Elisa followed by an IgeneX positve WB. He stops antibiotcs because he feels worse on them? Too bad nobody was around to tell him it was a herx. What's the followup on this guy who had disabling pain and exhaustion? They convinced him that he didn't have lyme and diagnosed him with what???
How many stories of people being misdagnosed by Mayo Clinic?
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