Testing Problems Response
Responding to a question asked about this paper...
http://jcm.asm.org/content/56/8/e00749-18.full
Question: Lucy Barnes do you agree with these findings ?
Response Below
1. Negative antibody tests should never be used to rule out the diagnosis of Lyme disease. Period.
2. The author (Adriana Marques) is in Wormser/Steere’s back pocket. Fails to produce work that can help chronic Lyme patients.
3. The study was funded by the same NIH/NIAID group that funds the other rotten Lyme studies.
4. Costs should not be part of the decision as to what tests are used. Yes, it is nice to keep costs lower IF possible and only ONCE the product is GOOD, but costs now get too big of a chair at the table and that consideration seriously and negatively affects patient care.
5. I can’t pull the info needed to support this right now- too much research for me at the moment- but I believe there is an internal war going on with these tests and the patents, etc. In other words, a subset of idiots are fighting another subset of idiots. And both sides have tests that are poor, but one side is trying to say the other’s tests are worse and theirs isn’t as bad.
Bottom line, patients don’t win. There are over 3 million tests run for Lyme each year, and the potential profits taint any hope of the idiots doing the best they can for our health care concerns. Plus, the vaccine trials will require a lot of Lyme tests, big bucks for patent holders, so this stuff is popping up again.
Commenting to quotes (in bold) from the article...
and false-positive IgM WBs are common in commercial laboratories (17).
After 30 years of reading tens of thousands of Lyme tests for patients I’ve NEVER seen a false positive test. False negatives, yes, in fact too many to count.
Other issues include the high cost, substantial training requirement, and the labor-intensive process to perform the test, leading to an increased turnaround time for the WB. Finally, a major problem is the confusion by health care providers and patients regarding how to interpret the results from the tests. Laboratories will report the presence of individual IgG and IgM scored bands, plus the result (positive or negative) for the IgM and IgG WB, independent of the duration of the disease, leading to much confusion, misinterpretation, and uncertainty (18).
These are all valid reasons both subsets of idiots have showing how bad the tests are and both can and do apply this list to the other's tests and not their own typically. They are both equally bad. Both are looking for profits over patient care.
It is estimated that about 3.4 million Lyme serologic tests are done in the United States every year (19). Therefore, it is likely that most testing is done in situations with a low pretest probability of Lyme disease, which increases the likelihood of false-positive tests (20, 21).
The pretest probability is a joke, shameful one at that. They’ve been pushing, for a really long time, a specific set of criteria that patients must fall into before you should test them for Lyme.
Example, if patients aren’t in an endemic area they shouldn’t be tested. If they are tested and the test is positive, the idiots say that is a false positive test. The whole thing is insane and I’ve never heard of any LLMD give this “pretest” garbage any credibility either.
Here is the pre-test for Lyme disease.
Later, a follow-up study using a WCS EIA as the initial test and a multiplex assay with VlsE1-IgG and pepC10-IgM as the second-tier test showed again an advantage compared to WB (13). None of these tests were approved by the FDA. An approach using two commercially available EIAs was proposed in Europe, with a study published in 2005 showing that if the results of an IgG EIA with four recombinant antigens and the C6 peptide EIA were concordant, immunoblotting could be omitted (24).
I believe it was Wormser or one of his renegade dog soldiers who also proposed this too, for the USA. Can you imagine what it would be like if there were no Western Blots? Almost no one would be diagnosed. In fact, Wormser recently proposed/mentioned in his recent study (more of a report) about changing the name of Lyme disease, that EM rashes would not be considered to be Lyme unless the patient’s tests were also positive.
Side note- think about this as it relates to falsely lowering the reported case numbers and how it relates to the vaccine trials. Anyone who had the vaccine who developed an EM rash would NOT be considered to have Lyme disease unless their tests were positive too. Since tests miss 74.9% of those with Lyme (and more during the EM rash stage), the vaccine would falsely appear to be much better than it would be if the tests were accurate.
This strategy was shown to be cost-effective in a reanalysis of the data from a large study of the C6 EIA (25).
Again, “cost effective” considerations when it comes to saving lives- actually BEFORE they even have an accurate way to make a determination about who has Lyme and who doesn’t- is hurting patients. That just doesn’t sit right with me. Get a good product, then work on lowering costs and then ONLY if it doesn’t affect the quality.
As shown here and in previous studies (4, 16, 26–29), MTT algorithms will be positive in only about 50% of acute-phase samples from patients with EM, while the STT algorithm will be positive in about 40% (Table 1).
That’s the bottom line- and the author is saying it- neither algorithms are worth a toot. (Again, think about how this will affect the accuracy of the reports from the vaccine trials.)
The MTT algorithm gives an overall single result (positive or negative) for seropositivity in Lyme disease, facilitating the interpretation of the test. The tests are less expensive and less labor-intensive, can be performed using automated instruments, and have objective, quantitative results. The MTT approach can also be used in patients who acquired the infection in Europe when such cases are evaluated in the United States.
Alternatively, the WB has the advantage of providing information regarding the expansion of the immune response, and the WB will still have a place in evaluating difficult cases. But for the vast majority of tests performed, this information is not necessary and only increases the confusion regarding interpretation of the results.
To me this sounds like a patent/money issue. It's like she is saying… our tests are better so we want to replace yours with ours, but in difficult cases we can still use yours too (throwing them a bone).
Moreover, the MTT algorithms open the way for a sensitive and specific point-of-care diagnostic for Lyme disease.
This would be a huge selling point if there were a test to provide instant and accurate results. Problem is, no one in their group cares how accurate it actually is or is not. It's all about the money.
These tests would be particularly useful in evaluating patients with stage 2 manifestations of Lyme disease, like facial palsy or carditis, as well as in children with arthritis. At this point, if these patients do not have other manifestations of Lyme disease (erythema migrans) or a very suggestive history, the diagnosis may depend on serological test results.
Tests should never be used as the deciding factor, and negative tests should never be used to dismiss a Lyme diagnosis. And missing all of the symptoms mentioned above without considering Lyme (without doing a test for supposed confirmation) is what is wrong now! Lyme is a clinical diagnosis. Period.
This research was supported by the Intramural Research Program of the NIH, NIAID.
I am a coinventor on U.S. patent 8,926,989 (34).
BINGO! This is using her patented test and she is claiming here that it is better. Pretty gutsy, don’t you think?
- Burbelo PD,
- Issa AT,
- Ching KH,
- Cohen JI,
- Iadarola MJ,
- Marques A
. 2010. Rapid, simple, quantitative, and highly sensitive antibody detection for Lyme disease. Clin Vaccine Immunol 17:904–909.10.1128/CVI.00476-09.
Check out the coauthors that have published with her. Some are and some aren’t some of the better known idiots, but people like Paul Fawcett (Delaware Dupont Children’s Hospital) (Fawcett- https://www.lymedisease.org/vaccine-chapter-of-cure-unknown/ ) and Mario Phillip, Steve Schutzer, Lantos from Duke, Barbara Johnson (oouuuu), Nowokowski (double oouuu), Dumler (Hopkins) Dennis (CDC), etc. have put a huge crimp in our ability to be diagnosed and treated.
Coauthors of Marques
http://jcm.asm.org/search?author1=Adriana+R.+Marques&sortspec=date&submit=Submit
Opinions above are by Lucy Barnes
July 2018
Last Update- March 2019
Lucy Barnes