Serologic testing is the principal means of laboratory diagnosis of Lyme disease. Current recommendations include using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay, followed by a western immunoblot assay for specimens yielding positive or equivocal results.
What is added by this report?
On July 29, 2019, the Food and Drug Administration (FDA) cleared several Lyme disease serologic assays with new indications for use, allowing for an EIA rather than western immunoblot assay as the second test in a Lyme disease testing algorithm.
What are the indications for public health practice?
When cleared by FDA for this purpose, serologic assays that utilize a second EIA in place of western immunoblot assay are acceptable alternatives for the serologic diagnosis of Lyme disease.
Lyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis. In 1994, the Association of State and Territorial Public Health Laboratory Directors, CDC, the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Council of State and Territorial Epidemiologists, and the National Committee for Clinical Laboratory Standards convened the Second National Conference on Serologic Diagnosis of Lyme Disease (1).
The conference proceedings recommended a two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results (1,2). Regarding the development of future tests, the report advised that evaluation of new serologic assays include blind testing against a comprehensive challenge panel, and that new assays should only be recommended if their specificity, sensitivity, and precision equaled or surpassed the performance of tests used in the recommended two-test procedure. To assist serologic test developers, CDC has made available, with support from NIH, a comprehensive panel of sera from patients with various stages of Lyme disease and other conditions, as well as healthy persons (3).
On July 29, 2019, FDA cleared several Lyme disease serologic assays with new indications for use based on a modified two-test methodology (4). The modified methodology uses a second EIA in place of a western immunoblot assay. Clearance by FDA of the new Lyme disease assays indicates that test performance has been evaluated and is “substantially equivalent to or better than” a legally marketed predicate test.
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Recommendation When cleared by FDA for this purpose, serologic assays that utilize EIA rather than western immunoblot assay in a two-test format are acceptable alternatives for the laboratory diagnosis of Lyme disease. Based on the criteria established at the 1994 Second National Conference on Serologic Diagnosis of Lyme Disease, clinicians and laboratories should consider serologic tests cleared by FDA as CDC-recommended procedures for Lyme disease serodiagnosis.
TX Lyme Mom
Frequent Contributor (1K+ posts)
Member # 3162
posted
My Comment: ELISA (enzyme linked immuno-sorbent assay) was bad enough as step #1 of a two-tiered testing process, but now they are recommending the elimination of the more reliable Western Blot test altogether and they are substituting another enzyme-based assay (EIA) instead.
I wonder what our ILADS LLMDs think about it, but it's probably too soon for them to have had time to consider and respond yet.
Anyone else here have any insights or thoughts about this?
PS -- I'm editing to add that anything that Paul Mead's name is attached to is highly suspect. He is NOT our friend!
Posts: 4563 | From TX | Registered: Sep 2002
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Tincup
Honored Contributor (10K+ posts)
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posted
Hey TX,
You hit the nail on the head!
Here is what I just shared elsewhere because another study just came out testing children with the new testing method. Link below.
Getting Rid of The Western Blot Tests?
Between this latest study on children and ELISA Lyme tests, the FDA's recent approval of the new, but bad anyhow, ELISA Lyme tests, and another study on the new methods that leave out the Westen Blots, and the CDC coming out recommending this method over Western Blots..
AND, the IDSA guidelines promoting these new garbage tests- all doing so just recently...
It sure looks to me like they are seriously trying to eliminate the Western Blots- the better tests.
I haven't had time to "follow the money" yet (patents, vaccines, etc.) but I can't figure why else they would be doing this because more people will be missed.
New study- notice the last named author was NOT our friend on the TBD working group and like the others is from OH SO AWFUL FOR LYME, Boston!!
hiker53
Frequent Contributor (5K+ posts)
Member # 6046
posted
I am never ceased to be amazed at the stupidity of some Md's and the CDC.
-------------------- Hiker53
"God is light. In Him there is no darkness." 1John 1:5 Posts: 8878 | From Illinois | Registered: Aug 2004
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Keebler
Honored Contributor (25K+ posts)
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posted
- hiker,
I think it's not due to stupidity of the IDSA / CDC / NIH at all. Well, actually, it may be partly as the science is very complex but so much is known about the complexity -
- as seen presented / written by many at ILADS conferences, etc. who all still admit so much is still to understand.
But the IDSA wants to keep it simple. So many of their own articles / "studies" have been proven wrong but it seems to be disregarded by them.
I think they don't want to have other doctors involved in their tight little club. They want to rule.
I also think humiliation and cruelty is the point. They seem to have an utter contempt for patients with advanced lyme, tick-borne infections. Contempt, disgust, hatred. It has been well displayed for decades.
And ego. They want to be the big boys on the block and boss around all other doctors. And, oh, profits.
Many of the decision makers also likely have stocks and get big bucks from the various tests and treatments for what happens when lyme (and other tick-borne infections) are not properly assessed & fully addressed.
All the symptomatic "relief" Rx as well as all the biologics for "autoimmune" issues that are instead big on diagnoses. -
Posts: 48021 | From Tree House | Registered: Jul 2007
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Keebler
Honored Contributor (25K+ posts)
Member # 12673
IDSA guidelines deny Lyme treatment to most of the US;
Read our rebuttal and make your own comments until September 9.
By Dorothy Kupcha Leland - LymeDisease.org - 15 August 2019 -
Posts: 48021 | From Tree House | Registered: Jul 2007
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TX Lyme Mom
Frequent Contributor (1K+ posts)
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posted
I think all of you smart people are missing the key point, and here's why:
I think the IDSA is starting to get very worried about defending themselves in the upcoming RICO (racketeering lawsuit) against them, which was filed in Dec. 2017 and which is due to start in Feb., 2020.
I knew one of the lead plaintiffs (who is now deceased, but whose widow stepped in to carry on in behalf of his estate). He was one of our leading lights in our Texas LDA, a really, really smart guy!
And because he was involved in this lawsuit, then I have no doubt whatsoever that it's been very well thought out in advance and that it is indeed winnable -- especially considering that it's a jury trial.
Any jury in Texas is not going to be favorably impressed by the IDSA's tactics, IMO. I surely wouldn't want to be one of the IDSA defendants myself, believe you me!
And I suspect that the CDC is in cahoots with the IDSA and is trying to protect their turf by trying to change the rules of the game regarding Lyme diagnosis.
Why would they do that, you might wonder. Well, remember that infamous Dearborn Conference way back in 1994 when they adopted the diagnostic criteria for Lyme disease. The CDC's charge from NIH was to "reduce the incidence of Lyme disease" -- so they attempted to do it with the stroke of a pen, by defining it out of existence.
Now do you savvy what's going on?
I can't prove it, but I'd be willing to bet a shiny dime to a dollar -- your dime, my dollar -- that I'm right on the target here.
Can anyone think of any good reason why I might be wrong?
I'm asking because I'm curious if I might be off base here, and I know there are a whole lot of very smart people here at Lymenet.
Posts: 4563 | From TX | Registered: Sep 2002
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TX Lyme Mom
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Here's their lazy excuse for their glaring omission:
"CONCLUSIONS: ..... As immunoblots are time-consuming, laborious, and challenging to interpret, MTTT provides a promising alternate Lyme disease testing strategy for children."
Those rascals oughta' be keel-hauled.... And then strangled if they survive being keel-hauled!
Talk about "man's inhumanity to man."
Their lack of caring compassion is inexcusable, especially with regard to children, of all human subjects.
This kind of behavior is downright abusive!
Posts: 4563 | From TX | Registered: Sep 2002
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Bartenderbonnie
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posted
Thanks to the freedom of information act, we can follow the money;
TX Lyme Mom
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posted
You made your point, Bonnie. Thanks for finding those links. I never would have known how to find them -- not sure I know how now, except to remember to look for the info here, under this topic at Lymenet.
.....although I do recall seeing this same chart in the "Under Our Skin" documentary.
Much appreciated, Bonnie.
And now it becomes much clearer why the authors of the recent PubMed articles didn't want to compare any of their new Lyme diagnostic enzymer-based (EIA) tests with any of the Western Blot diagnostic tests, of course!!!
This raises the next question: How and why is the CDC complicit in giving these new enzyme-based tests their stamp of approval? Well, I guess the CDC would have to approve these new tests if they meet certain standards of accuracy, but let's see where it goes from here.
As long as the CLIA doesn't try to shut down Igenex -- (again, like they tried to do in the past) -- then I don't foresee any real problems -- but maybe I'm naive.
Only time will tell how all of this plays out.
I'm curious how our ILADS doctors will deal with this development if my forebodings become reality.
I'm waiting to exhale......
Posts: 4563 | From TX | Registered: Sep 2002
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Rumigirl
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posted
quote:Originally posted by Bartenderbonnie: Thanks to the freedom of information act, we can follow the money;
LOTS OF CONFLICTS OF INTEREST!!! But we already knew that. . . TIME TO HOLD THEM ACCOUNTABLE!!!!
(Sorry about the small format. PDF is in Windows)
bb, Thank you!!
Mods: This post should be a sticky on General!!
Posts: 3771 | From around | Registered: Mar 2008
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TX Lyme Mom
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Member # 3162
posted
Don't forget that another major motivating factor for any academic researcher is the ability to acquire federal grants to support their research. (I know because my husband is an academic researcher, but in another scientific field, not medicine.)
Therefore, my next question would be to look at their sources of funding for all of their published research. These guys want to stay in the good graces of the research funding agencies; otherwise, their careers are curtailed.
So, where is the real pressure coming from to suppress the diagnosis of Lyme disease?
I have my suspicions, but they are rather sketchy, and I'd rather not say too much about it. The only reason I'm mentioning this idea at all is to plant this thought for your consideration.
Let me repeat: Where is the real pressure coming from to suppress the diagnosis of Lyme disease?
Hint: The FDA approved a new EIA diagnostic test to replace the Western Blot test, which is the original subject of this topic. That's a big clue, especially because the CDC publicized it in the MMWR.
Remember Dearborn back in 1994. I sense that the same political and economic forces are at work again now, trying to suppress the diagnosis of Lyme disease, rather than trying to focus on curing it.
I'm not too pessimistic though because I sense that disulfiram (Antabuse) is going to prove to be a cost-effective treatment for late-stage, chronic Lyme and Bartonella, once the dosage protocols are worked out.
OK, we need to get to work studying the list of names of these new IDSA panel members to see where their past sources of funding have come from. That's not going to be a small task, but it's going to be a major clue, IMO.
So let's get started.... If anyone want to help out, then choose just one name and start searching for all of his/her past publications and sources of funding, which are usually listed at the end of each article.
This effort will need its own separate topic, just for this special purpose, but I'm not going to be able to start working on it for a couple of days, so don't wait for me to initiate it, please.
Posts: 4563 | From TX | Registered: Sep 2002
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