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.''
Medical Diagnostic Labs -- http://www.mdlab.com
Stoneybrook (SUNY) -- Note write on orders -- Request that ALL bands be reported http://www.path.sunysb.edu/labs/ticklab/TICKLAB.htm
Bea Seibert
Several years ago, they were good at only one lyme thing, and that was testing.
Actually I was disappointed when I looked at the MDL site -- they don't appear to offer the recombinant antigen test anymore and that was the test hubby had the most luck with.
Oh well, I'm just not sure I would be willing to shell out any money for any tests from any lab at this point in hubby's treatment. But that is just my opinion.
Bea Seibert
quote:
Originally posted by lynliz:
LLMD's are denying their patients meds because of the whole thing happening with Igenex.
If an LLMD is denying patients care based on this NY times article, then they aren't much of an "LLMD" in my book. Sounds like a duck to me.
I agree with MDL or Bowen as possibilities. Here's something else you may need.
Western Blot explanation: http://flash.lymenet.org/ubb/Forum1/HTML/022767.html
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Do not take anything I say as medical advice. I am not a doctor, but I DID stay at a Holiday Inn Express!
oops!
Lymetutu
[/B][/QUOTE]

Trout
quote:
Originally posted by lynliz:
Lymetutu again BIG thanx I'm dancin!
Finally understand my western Blots thank you!
My mom also says thanks. L
Yes, Dr C's explanation is the best I've seen. The WB makes so much sense after reading it! Glad you liked it!
Kayak....Quest S**KS!! It's not a valid test for Lyme, in my opinion!
Go with Igenex in CA. www.igenex.com
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Do not take anything I say as medical advice. I am not a doctor, but I DID stay at a Holiday Inn Express!
oops!
Lymetutu
Quest is a crock. Do not even consider using them. My duck here in Hell sent off a blood sample to those clowns, specifically after I had forbidden him to do it and the damn thing came back negative. I had alread had a positive WB from Igenex with lots of negatives with interesting positive bands that really would not be positive it there were not something there-like lyme disease, for instance.
I was also sick as a dog and exhibiting those symptoms which would be consistent with a diagnosis of lyme disease. My duck dismissed the whole business and needless to say I have dismissed him. The quest test came back with a 41 kDa positive. Now pray tell me what was I doing with a positive 41 kDa and all those symptoms? Of course the fool called me crazy and prescribed an anti-depressant. Can you believe this? In any case avoid Quest like the plague. Cheers. Thomas Parkman
By the way, I also agree about Quest. Had negative ELISA which got me practically laughed out of the doctors office when I had the nerve to ask for a western blot. But did find a wonderful LLMD who treats based on symptoms while trying to confirm the disease and said something that I will never forget, that he didn't want me to be sick any longer than I had to, that I had been sick long enough! Validation means so much with this disease.
Maybe this will help explain.
Camp A and Camp B http://flash.lymenet.org/ubb/Forum1/HTML/021395.html
Lyme Wars http://www.wildernetwork.org/Lyme_Wars.html
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Do not take anything I say as medical advice. I am not a doctor, but I DID stay at a Holiday Inn Express!
oops!
Lymetutu