New Lyme Disease Tests Could Offer Quicker, More Accurate Detection
In an analysis published on December 7 in Clinical Infectious Diseases, scientists from Rutgers University, Harvard University, Yale University, the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and other academic centers, industry and public health agencies say new diagnostic methods offer a better chance for more accurate detection of the infection from the Lyme bacteria.
“New tests are at hand that offer more accurate, less ambiguous test results that can yield actionable results in a timely fashion,” said Steven Schutzer, a physician-scientist at Rutgers New Jersey Medical School and senior author. “Improved tests will allow for earlier diagnosis, which should improve patient outcomes.”
Lyme disease is the most common tick-borne infection in North America and Europe. There are currently over 300,000 cases of Lyme disease annually in the United States alone, and the disease is increasing and spreading into new regions. Lyme disease frequently, but not always, presents with a bull’s-eye rash. When the rash is absent, a laboratory test is needed.
The only FDA-approved Lyme disease tests, based on technology developed more than two decades ago, rely on detecting antibodies that the body’s immune system makes in response to the disease. These antibody-based tests are the most commonly used tests for Lyme disease and are the current standard.
“New tests are more exact and are not as susceptible to the same false-positive or false-negative results associated with current tests.” said Schutzer.
Schutzer and his colleagues say more accurate testing would help doctors decide when to prescribe the antibiotics used to clear the infection and help avoid severe long-term health problems. Antibody tests, can take three weeks or more for the antibody levels to reach a point where the tests can pick up a positive result.
Those involved in the paper joined forces after meeting at Cold Spring Harbor Laboratory’s Banbury Center, a nonprofit research institution in New York. The meeting organized and chaired by Schutzer and John A. Branda, assistant professor of pathology at Harvard Medical School, focused on current Lyme disease tests and new scientific advances made in increasing the accuracy of the diagnosis.
“This meeting and paper resulting from it are particularly significant,” said Jan Witkowski, professor in the Watson School of Biological Sciences at Cold Spring Harbor Laboratory who along with Nobel Laureate James Watson asked Schutzer to lead several symposia. “The participants noted that there are greatly improved diagnostic tests for Lyme disease that can be implemented now, and that the way is open to the development of further tests.”
The article fails to mention these “better tests” and the abstract fails to do so as well, except to say that next-generation serodiagnostic testing, focusing on methods that are currently available or near-at-hand, can now overcome or circumvent many of the past drawbacks. Abstract found here: https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/cix943/4706288?redirectedFrom=fulltext
Those of us in Lyme-land have known for decades that better testing is available, it’s just mainstream medicine refuses to use them. I know of a patient who after testing negative on the CDC two-tiered testing, went to a Lyme literate doctor who used the extended Western Blot from IgeneX and tested positive. When she showed up with proof in hand, the regular doctor announced that test was faulty, threw it into the trash, and then without permission, retested her again with the CDC two-tier testing. When the patient showed up at a follow-up appointment, the doctor smugly announced she did not have Lyme because the second CDC test was again negative.
This is the type of thing Lyme/MSID patients are used to and what we advocates warn folks of. Do not expect a regular doctor, at this point in time, to embrace any testing methods other than the CDC two-tiered testing. They will even tell you they are FDA-approved which is only half the story. The FDA does not require approval for labs that do not sell test kits (such as IGeneX). There are all sorts of laboratory standards and IGeneX is a CLIA-certified high complexity testing lab with on site inspections by state and federal inspectors every two years in states that have the most stringent lab requirements (New York, and California). They are a small lab specializing in bacteriology and virology – not a monopoly that tests for everything from staph to strep.
Go here for IGeneX accreditations, certifications, and licenses: https://www.igenex.com/why-igenex/licenses-accreditations/ You can print these out and attempt to show your general GP; however, I wouldn’t hold my breath despite the concrete evidence.
Rivoting here a moment, I remember attending a public forum at the WI capital where a pediatric doctor called the IGeneX test, “Home brewed,” obviously deriving that particular wording from here: https://www.igenex.com/why-igenex/licenses-accreditations/
I assure you, CLIA has tough standards and would not allow a lab to exist if it didn’t cut the muster. The problem, once again, is that doctors are woefully uneducated and fall back on quick articles like these to pass judgement, rather than studying the issue for themselves. This lack of due diligence has unfortunately affected thousands of people who are sent home and denied treatment due to a negative test.
Lyme patients and advocates have been screaming bloody murder for years over the conflicts of interest and CDC testing monopoly. Go here for the sordid story: https://crymedisease.wordpress.com/2016/02/28/the-conspirators-they-own-the-patents-and-changed-the-testing/ (spoiler alert – they own the patents to the tests)
https://on-lyme.org/en/sufferers/lyme-stories/item/261-unprecedented-claim-against-the-cdc-over-lyme-tests The CDC commitment to the national study abruptly stopped with no reasons given. However, it appears the CDC is focusing on developing their own newly patented test rather than supporting a group of innovators that compete with the CDC patents.
https://madisonarealymesupportgroup.files.wordpress.com/2018/01/09bc3-uos2_claim_references_2.pdf The CDC denies patent holding despite it being right here in purple crayon.
In conclusion and purposely focusing on the silver lining, this article will hopefully poke the scientific world from its 40 year nap and be a reminder that the outcome of the most prevalent vector-borne disease on the planet has been stymied by a lack of diagnostic testing and that more accurate testing is required.
Hopefully it will also begin the breakup of the love-affair the CDC has for two-tiered testing.
For more on testing: