timaca
Frequent Contributor (1K+ posts)
Member # 6911
posted
Anyone know why bands 31 and 34 were left out of the CDC's required list of bands for a positive WB test?
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Michelle M
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Member # 7200
posted
Yes.
The "ostensible" reason is that those bands are what was used for the vaccine LymeRix.
Therefore, people who show those bands on their blot might just be people who have had the vaccine, so we must therefore EXCLUDE those bands so as not to give a "positive" to people who don't have lyme but simply had the vaccine.
Now, in reality, very few people even had the vaccine, thank heaven, so throwing out those incredibly specific bands from a test for a disease as hard to pin down as lyme is the pinnacle of STOOPID.
But in my opinion, the CDC and the IDSA actually do not WANT people to be diagnosed.
Kind of the same line of reasoning as to why they continue with the two-step ELISA testing garbage, even though ALL PARTIES NOW AGREE that it misses MORE THAN 50% of lyme positive patients.
But that's just great! Let's go on missing them! Life is grand!
(Stepping on soapbox now.)
Michelle
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timaca
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Member # 6911
posted
Thanks, Michelle....I had thought that might be the reason. It seems it would be easy enough to ask someone who is getting a WB if they have had the vaccine or not.
I was a bit confused about the soapbox. Were you on or off it as you gave your answer?
Timaca
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Michelle M
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Member # 7200
posted
quote:Originally posted by timaca: Thanks, Michelle....I had thought that might be the reason. It seems it would be easy enough to ask someone who is getting a WB if they have had the vaccine or not.
I was a bit confused about the soapbox. Were you on or off it as you gave your answer?
Timaca
Hey Timaca. You have the magic answer - why not just ASK the person if they had the vaccine? Wouldn't that make a lot more sense than misdiagnosing thousands of people by leaving those ultra-specific bands completely off the western blot???
Sorry, I get extremely worked up about testing issues and tend to be "ON" my soapbox about them. Not at you. At THEM!!
Testing isn't accurate to begin with, but requiring a positive ELISA first, then excluding bands 31 and 34 from a western blot next, is the death knell to ever being diagnosed with lyme disease unless you're extremely lucky.
I know of no other disease where "roadblocks" (the ELISA) with a 50% or greater known failure rate are intentionally placed in the way of diagnosis, despite the presence of better and more accurate tests.
Michelle
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quote:Originally posted by Michelle M: [QUOTE] I know of no other disease where "roadblocks" (the ELISA) with a 50% or greater known failure rate are intentionally placed in the way of diagnosis, despite the presence of better and more accurate tests.
Michelle
NO kidding!
-------------------- --Lymetutu-- Opinions, not medical advice! Posts: 96220 | From Texas | Registered: Feb 2001
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trails
Frequent Contributor (1K+ posts)
Member # 1620
posted
It is for the reasons michelle says but not so innocent. It is money involved and malpractice. The docs who made the vaccine have been trying to distance themselves from it becoz it caused so many problems for people. So one way to distance was to actually say that those bands arent important after all, when we know they ARE.
They dont want to be sued for all the damages done by the vacinne. So they claim that chronic lyme does not exist and they pull those bands from the test.
before the vacinne these same docs have published papers about chronic lyme and about those bands. I dont have the references but i bet cave does some where. They changes their tune as the vacinne failed.
do you have 31 and 34 timaca?
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timaca
Frequent Contributor (1K+ posts)
Member # 6911
posted
HI Michelle~ I know you aren't on a soapbox towards me (as I am darn near perfect )...and I totally understand your frustration about lyme testing. If someone would come up with a reliable test, much of the controversy surrounding lyme would disappear.
Trails~ I have consistently tested positive on band 34 from both Igenex and Stonybrook...several times over. Never on band 31; however positive on band 30 from both labs (which Dr. F says is highly specific for lyme). I've also tested positive on most of the other bands, but never, interestingly enough, on bands 23-25....and not one positive band from MDL lab either (ever) (many from Stonybrook and Igenex).
I was just asking the question for my husband is now getting tested for lyme (results from stonybrook are in, we are off to pick them up now)...and we were discussing the band 31,34 issue.
Timaca
Posts: 2872 | From above 7,000 ft in a pine forest | Registered: Feb 2005
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First of all, keep in mind that it is NOT disputed - by anyone - that bands #31 and #34 are the most specific markers, almost never occuring in controls.
But the CDC & Friends didn't sit around and say, "what are the most specific markers of Lyme?" Far from it.
Their method was to look for which bands occurred most frequently in patients vs. controls. (Patients identified by them, meaning people mostly with EM rashes and/or arthritis. Not chronic neuro cases.)
Their stated "rationale" was that those specific bands (#31, 34) occurred infrequently in their patients, so statistically these markers weren't "useful."
Band #31 only occurs later in the disease, which is why they didn't see much of it - and why the marker is VERY important for anyone with late neuro Lyme.
But the CDC wasn't that worried about missing late cases. Why? (The only logical explanation is that the vaccine ($) was the main concern.)
"As one immunologist remarked shortly after the 1994 CDC conference, 'If OspA [#31] is so unimportant, then why the heck are we vaccinating people with it?'"
And now things have gotten WORSE... because without EM rash, the IDSA has now made the CDC criteria REQUIRED for diagnosis.
It's time to fight this unscientific, inhumane garbage. www.lymenews.orgPosts: 621 | From US | Registered: Jun 2006
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
quote:Originally posted by ldfighter:
Band #31 only occurs later in the disease, which is why they didn't see much of it - and why the marker is VERY important for anyone with late neuro Lyme.
I have 31*** in addition to other positive bands and am CDC positive. I know I am lucky my immune system was still kicking enough to register a good response.
In testing, people with late stage lyme are really screwed.
You are almost guaranteed to "fail" an ELISA. I did.
Unless you're using IGeneX and looking at the late-stage bands, you're probably going to fail a standard western blot too.
Then there you are. Perhaps suffering horribly, but according to the IDSA, you don't even have lyme disease.
The good news? Almost everyone I know, even people without lyme, knows that if you get lyme you absolutely must see a lyme-literate doctor. So hopefully fewer and fewer people will fall into the hands of IDSA quacks.
Michelle
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TerryK
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posted
quote: Kind of the same line of reasoning as to why they continue with the two-step ELISA testing garbage, even though ALL PARTIES NOW AGREE that it misses MORE THAN 50% of lyme positive patients.
CDC recommends a two-step process when testing blood for evidence of Lyme disease. Both steps can be done using the same blood sample.
1) The first step uses an ELISA or IFA test. These tests are designed to be very ``sensitive,'' meaning that almost everyone with Lyme disease, and some people who don't have Lyme disease, will test positive. If the ELISA or IFA is negative, it is highly unlikely that the person has Lyme disease, and no further testing is recommended. If the ELISA or IFA is positive or indeterminate (sometimes called "equivocal"), a second step should be performed to confirm the results.
Be sure to check out the rest of what they say. Terry
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Michelle M
Frequent Contributor (1K+ posts)
Member # 7200
posted
The fact the CDC can still say this in light of the facts would be laughable, if it were not criminal.
Michelle
From Journal of Spirochetal and Tick-borne Diseases--Volume 5, Spring/Summer 1998
There are a large number of commercial ELISA tests available. A review of past proficiency events by CAP and the NYS Health Department show the relationship between the various tests. Most commercial ELISA tests have comparable sensitivity and specificity because they were made to compare to one another for the FDA 510K process. However, most are inadequate as a screening test because they were not designed by the manufacturers to be sensitive at the 95% level, which is required for screening (14). A substantial change in the 510K approval process would be required to make the ELISAs for Lyme disease diagnosis more sensitive.
The goal for a new generation of ELISAs should be sensitivity for the more unique and specific B. burgdorferi antigens that are visualized in the Western blot (Figure 1). They are Osp A (31 kDa), Osp B (34 kDa), Osp C (23-25 kDa), 39 kDa, and 93 kDa (27-32).
Initially, some investigators identified 93 kDa as 94 kDa and Osp C as 22 kDa. While most ELISAs do have reactivity to these antigens, because they are prepared with a sonicate of B. burgdorferi, they also have reactivity against 41 kDa, 58 kDa, 66 kDa, and 73 kDa. While the later antigens are components of B. burgdorferi, they also have considerable cross-reactivity to other spirochetes, heat-shock proteins, and some viruses (33).
All borderline and positive ELISA assays (polyvalent, IgG only, and IgM only) for Lyme disease must be confirmed by a high quality Western blot for B. burgdorferi. A 56% false-negative rate, depending upon the commercial kit, was found by Luger and Krause (18), as compared to their own clinical diagnoses. Golightly et al (34) saw a lack of sensitivity with a 70% false-negative rate in early Lyme disease and from 4% to 46% with late manifestations of Lyme disease. These results support the necessity of Western blot confirmation for both positive and negative Lyme ELISA."
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