posted
Sorry for the negative tone. I dont want to sound like a New York Times reporter dissing Igenex. But I was thinking about this and I recently read This article that got me thinking more.
I guess I would like some clear facts before I send more blood work to them.
What kind of proof do we have that the lab tests being done at Igenex are 100% reliable and we're getting what we intend?
Has there ever been a thorough investigation done on this private lab to confirm that they are legitimate?
How are they different from other labs that test for lyme? (Like if you went to the mayo clinic or something and they did lyme test)
thanx
edit: (I found this from another article) Can anyone comment on this??
In April 2000, the New York Department of Health wrote Stephens that Igenex had failed a "proficiency challenge" involving 20 samples. The test failed to find two samples that had been "spiked" with Borrelia burgdorferi, the bacteria that cause Lyme disease. The tests incorrectly reported as positive four of 14 negative samples.
Similarly, the New York department had Igenex perform tests for Babesia microti, the bacteria that cause babesiosis. One type of test had a false positive rate of 80 percent, another of 50 percent. A third test using microscopic analysis had a 90 percent overall error rate.
"Igenex's results were clearly unsatisfactory and failed to meet even minimal standards for diagnostic testing," wrote Richard Jenny, acting director of the state's clinical laboratory evalution program.
In the ensuing period, Igenex was engaged in an ongoing battle with inspectors from California's Laboratory Field Services Unit, which monitors the safety and effectiveness of medical testing labs -- and works as an agent for federal regulators.
In April, federal regulators formally threatened to impose sanctions on Igenex for repeatedly failing to measure up after inspections found deficiencies -- many involving paperwork errors or lack of training among lab staffers. Payments from the Medicare program were suspended.
Posts: 170 | From Vancouver | Registered: Apr 2006
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bettyg
Unregistered
posted
jon,
do some more research please:
1. use SEARCH found at the top under new post. type in IGENEX medical topic line ANY DATE.....make sure you EDIT MY PROFILE FOR ANY DATE...LONGEST TIME SHOWN vs. default!
leave membership no. blank, and hit send/search key below the box. all posts will show up to 300 MAX.
READ REACH OF THEM FOR ANSWERS; IT'S BEEN ANSWERED BEFORE IN DEPTH.
2. go to www.igenex.com and read on there all comments by Nick Harris about these charges.
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CaliforniaLyme
Frequent Contributor (5K+ posts)
Member # 7136
posted
And HOW do we know that the IDSA isn't right and that chronic Lyme shouldn't be treated with longterm antibiotics????????????????????????
Well... because abx saved my life!!!!!!!!!
Igenex? No, we don't know. Personally, I know so many people with Igenex NEGATIVES who got BETTER with treatment that I think they have a VERY HIGH RATE of FALSE NEGATIVES!!!!!!!!!!!
Just my experience of facilitating a TBD group for 8 years... not that it matters!! Heck, what is real life experience>? Anecdotal garbage!!!
There is no chronic Lyme disease anyway! Right>? That's what doctors around here told me after diagnosing me with it!!!!!!!!!!!!!!!!!!!!!!!!!! And then diagnosing me with post-Lyme syndrome- Chronic Lyme>? HA!!! No, Sarah, you have A PROGRESSIVE MULTI-SYSTEM NEUROLGICAL DISEASE TRIGGERED BY POST-LYME SYNDROME!!
and positive by UNILAB!!!!!!!!!!!!!!!!!!!!! The ONLY person EVER in our town that I have met!
When we have the HIGHEST MIR in ADULT TICKS 17.8% in ALL OF CALIFORNIA!!!!!!!!!!!!!!!!!!!!!!!!!!!! So when people test positive at Igenex- IT MAKES SENSE!!!!!!!!!!!!!!!!!!
What does NOT MAKE SENSE is ME, being THE ONLY PERSON I HAVE EVER MET WHILE DOING THIS GROUP WHO TESTED POSITIVE AT UNLIAB!!!!!!!!!!! THAT DOES NOT MAKE SENSE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
-------------------- There is no wealth but life. -John Ruskin
All truth goes through 3 stages: first it is ridiculed: then it is violently opposed: finally it is accepted as self evident. - Schopenhauer Posts: 5639 | From Aptos CA USA | Registered: Apr 2005
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quote:What kind of proof do we have that the lab tests being done at Igenex are 100% reliable and we're getting what we intend?
I know it's confusing when you hear different things. No test, no lab is 100% reliable - far from it. But according to NY State proficiency tests, Igenex scored the best. The results are here: http://www.personalconsult.com/articles/igenex/igenex.pdf
quote:Has there ever been a thorough investigation done on this private lab to confirm that they are legitimate?
Igenex is - like Quest, Labcorp etc. - another private, fully licensed lab that has passed all proficiency tests. And according to NY State, Igenex has the highest marks for accuracy. So yes, they have been fully evaluated and if they hadn't succeeded in their evaluation, they would have been shut down. See pdf above.
quote:How are they different from other labs that test for lyme? (Like if you went to the mayo clinic or something and they did lyme test)
1. Igenex uses two different strains in their test, while other labs use just one. The second strain allows for more sensitivity in late-stage lyme, which is probably why they pick up more cases.
2. Igenex reports all Lyme specific bands, while most labs only report the ones that are on the CDC list. Bands #31 and #34 are specific enough that they've tried to make vaccines from these antigens, so they're widely acknowledged to be significant - but most labs will NOT tell you if you have a response to them. That is a huge problem for these other labs.
Why does the NY Times not report these things? I don't know, probably the same reason they brand Lyme patients as hysterics. For whatever political reason the Times has a history of denying the existence of chronic Lyme, so a fully certified lab that finds evidence of Lyme infection in chronically ill patients represents a threat.
On the same website where you found that NY Times article, there's also an explanation that Igenex was fully recertified in 2005 ("The Scrutiny Ends for Igenex Labs") http://www.ctlymedisease.org/headlinestory02.htm
Igenex's point of view: It's better to use multiple strains, report all bands. More sensitive and accurate.
The other side: Gee, there must be something wrong with Igenex if they're finding all these positives (rumor).
(I have zero affiliation with Igenex btw. Also, keep in mind that Lyme is ultimately a clinical diagnosis.)
Posts: 621 | From US | Registered: Jun 2006
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posted
Last I have read Igenex reports about 55-60% positive. Which I think is still low. Most people that are tested at Igenex have gone to LLMD's and have been clinically diagnosed.
Posts: 649 | From United States | Registered: Dec 2003
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mojo
Frequent Contributor (1K+ posts)
Member # 9309
posted
Igenex is not 100% accurate. They don't claim to be, either.
Just like some of our good Lyme Doctors they went through some sort of investigation and they came out just fine.
Unfortunatley unreliable testing is part of our problem. Igenex happens to be the most reliable lab.
I am waiting to hear some news about the new lab "Central Florida Research" Their testing is supposed to be excellent but they just opened March 1, 2007.
Posts: 1761 | From USA | Registered: May 2006
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hiker53
Frequent Contributor (5K+ posts)
Member # 6046
posted
I was tested at Mayo and found not to have lyme.
I was tested at what was Bowen and found to have lyme.
I was retested at Igenex and found to have Lyme.
A friend told me before I was tested anywhere that I had Lyme.
Hiker
-------------------- Hiker53
"God is light. In Him there is no darkness." 1John 1:5 Posts: 8933 | From Illinois | Registered: Aug 2004
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posted
From the info I have read the Central Florida Research test is a one of a kind antigen test. The lab was required to use the Western Blot as the 'gold standard' in the comparisons required for both State & CLIA approval.
CLIA approval is to labs and testing as FDA approval is to foods and drugs. Both the CFR lab and the new test, which is a fluorescent antigen test by Flow Cytometry, have received CLIA approval.
Explanation of State & CLIA approval: The Central Florida Research Lab was inspected by a team of Inspectors from the Florida Agency for Health Care Administration (AHCA) and the Centers for Disease Control (CDC) and Prevention, Atlanta (Bacterial Zoonoses Branch, Division of Vector-Borne Infectious Diseases).
The CLIA program (Clinical Laboratory Improvement Amendments ) is administered by the Centers for Medicare and Medicaid Services (CMS), an agency of the Department of Health and Human Services. CLIA certification (approval) is required for all laboratories performing clinical laboratory testing. You can view these Certifications at the Central Florida Research website: www.centralfloridareseach.org
Both the State and CLIA approved the Lab and the new Lyme antigen test without any recommendations.
I had the test and I was positive...which goes right along where I am right now in my treatment.
Rocker
Posts: 9 | From NJ | Registered: Mar 2007
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quote:Originally posted by Rocker: From the info I have read the Central Florida Research test is a one of a kind antigen test. The lab was required to use the Western Blot as the 'gold standard' in the comparisons required for both State & CLIA approval. This new test out performed the Western Blot by 29%.
CLIA approval is to labs and testing as FDA approval is to foods and drugs. Both the CFR lab and the new test, which is a fluorescent antigen test by Flow Cytometry, have received CLIA approval.
Explanation of State & CLIA approval: The Central Florida Research Lab was inspected by a team of Inspectors from the Florida Agency for Health Care Administration (AHCA) and the Centers for Disease Control (CDC) and Prevention, Atlanta (Bacterial Zoonoses Branch, Division of Vector-Borne Infectious Diseases).
The CLIA program (Clinical Laboratory Improvement Amendments ) is administered by the Centers for Medicare and Medicaid Services (CMS), an agency of the Department of Health and Human Services. CLIA certification (approval) is required for all laboratories performing clinical laboratory testing. You can view these Certifications at the Central Florida Research website: www.centralfloridareseach.org
Both the State and CLIA approved the Lab and the new Lyme antigen test without any recommendations.
I had the test and I was positive...which goes right along where I am right now in my treatment.
Rocker
Posts: 9 | From NJ | Registered: Mar 2007
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Do you have this information from an outside source? Does the NY department of health post these proficiency results?
That would be the hammer on the nail for me... If I could present a doctor with this Info COMING directly from the NY state deparment of health rather than what Igenex has.
Posts: 170 | From Vancouver | Registered: Apr 2006
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
Hi Jon.
I can't find any links to the NY Dept of Health online to query them.
However, rest assured Medicare and Medicaid would NOT be paying IGeneX billings if they weren't certified. Also, I strongly doubt they would publicly claim to be certified if in fact they're not.
You might PM Nimzovich (member#9758). He believes IGeneX is actually lying about its certification, and said he would be personally writing the New York Dept. of Health. He expressed the hope that I would be "psychologicaly [sic] fit" to handle the response. Oddly enough, I haven't seen anything further from him on it.
Michelle
Posts: 3193 | From Northern California | Registered: Apr 2005
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
From the Archives of Internal Medicine, 150:761, 1990:
"In one serious test of the Lyme Western Blot testers, there was a stunning finding. They used nine clearly infected patients and sent their blood to 18 labs. Of the IgG type of antibody, some labs were wrong. They missed 10 of 18 samples. For the IgM type of antibody, the labs were occasionally so bad they falsely reported Lyme as absent in 16 of 18 samples. (Arch Intern Med 150:761-763, 1990)."
Now, in view of that, it sure seems odd that IGeneX is under attack constantly, doesn't it?
Wonder how THESE labs would hold up to the type of scrutiny that IGeneX faces constantly?
Obviously, according to peer reviewed research, NOT.
Yet, the IDSA LOVES these labs since they constantly miss lyme, not the other way around! Do you see anyone wanting to investigate these labs? I guarantee you that that no scrutiny will ever be visited on them.
I do lament not having enough money to send blood samples to these poor quality labs just to mock them.
Michelle
Posts: 3193 | From Northern California | Registered: Apr 2005
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posted
Great points Michelle. You sound pretty psychologically fit to me, btw! (What a bizarre rant that was.)
What I would do if my doctor was skeptical, is bring him the information about how the Igenex western blot differs. That explains why they find more positives (with science not politics): http://www.igenex.com/innovations3.htm
quote:ldfighter thanks for the links...
Do you have this information from an outside source? Does the NY department of health post these proficiency results?
To my knowledge they do not post them publicly, you would have to contact NY State yourself. Or you might try contacting the reporter of the following article published last year in the San Francisco Chronicle:
The article says "In New York state proficiency tests, IGeneX has received a score of better than 95 percent, and, out of 58 labs tested, only IGeneX, had a perfect score for its Western "blot proficiency test."
[ 21. March 2007, 10:02 AM: Message edited by: ldfighter ]
Posts: 621 | From US | Registered: Jun 2006
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CaliforniaLyme
Frequent Contributor (5K+ posts)
Member # 7136
posted
Michelle, I think you are ok!!
-------------------- There is no wealth but life. -John Ruskin
All truth goes through 3 stages: first it is ridiculed: then it is violently opposed: finally it is accepted as self evident. - Schopenhauer Posts: 5639 | From Aptos CA USA | Registered: Apr 2005
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