LYME TESTING IN 1990 COMPARED TO 2020,
30 YEARS LATER…
Dr. Douglas Wine
Founder of Lyme Laser Centers, Inc.
So what has changed since 1990?
- The internet did not exist
- Gas cost $1.09 a gallon
- The average US income was $28,650
- George Bush (#1) was president
- Goodfellas, Home Alone, and Dances with wolves were the top movies
- #1 song was “Another day in paradise” by Phil Collins
- Wayne Gretzky won the Stanley cup MVP
- Pete Sampras won Wimbledon
- Cindy Crawford and Brooke Shields were sex symbols
But one thing hasn’t changed… Lyme testing (and maybe Cindy and Brooke are still icons).
The testing procedures and guidelines are greatly unchanged. According to the CDC, in 1990 the number of active cases of Lyme disease totaled fewer than 1 Million. Today, the data provided by the CDC lead to estimates that there could be between 12 to 24 Million active cases in the USA alone.
We should point out that the criteria for determining if your Lyme test is positive is based on a CDC-led scientific group that included the FDA and State laboratory directors back in the mid-’90s.
Unfortunately, the CDC openly acknowledges the inadequacy of testing but refuses to adopt new sciences while still expecting you to rely on a recommendation from over 25 years ago when Lyme disease was still wildly understudied and even discredited as an infectious disease. In the Second National Conference on Serologic Diagnosis of Lyme Disease held October 27-29, 1994, “It was recommended that an IgM immunoblot be considered positive if two of the following three bands are present: 24 kDa (OspC) *, 39 kDa (BmpA), and 41 kDa (Fla). It was further recommended that an IgG immunoblot be considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC) *, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa.” (1) (2) (3)
The article referenced above can be found as a link on the CDCs page for Diagnosis & Testing. The disclaimer at the bottom of the article will tell you that “The apparent molecular mass of OspC is dependent on the strain of B. burgdorferi being tested.” Today, we know that there are over 100 recognized strains of B. burgdorferi in the US alone and 300 strains worldwide. The article by the CDC also notes that you should only be considered positive if both results of their two-tiered testing approach are positive, but if you present positive for IGM (active antibodies) and you’ve felt unwell for more than 30 days, that positive result should be disregarded. (4)
The entirety of this recommendation falls on the results of two studies. One performed by Dressler, Whalen, Reinhardt and Steere, published in 1993, (Dressler F, Whelan JA, Reinhart BN, Steere AC. Western blotting in the serodiagnosis of Lyme disease. J Infect Dis 1993;167:392-400) and the other by Engstrom, Shoop, and Johnson, published in 1995. (Engstrom SM, Shoop E, Johnson RC, Immunoblot interpretation criteria for serodiagnosis of early Lyme disease. J Clin Microbiol 1995;33:419-22) The first study was performed on 255 patients, and boasted a sensitivity of only 32%. The second is performed much the same way, with only 55 patients in the study, all of which were confirmed “early Lyme disease and physician-documented erythema migrans”.
Unfortunately, many years later, the Western Blot is still shown to be only 29-40% accurate in detecting antibodies in the first few weeks of infection, which is the most critical time to begin treatment. (5)
To complicate this further, the two-tiered CDC recommended tests, which includes the ELISA (enzyme-linked immunosorbent assay) in addition to the Western Blot, are nearly exclusively equipped to detect one strain of one species of Borrelia: Borrelia burgdorferi (Bb ss B31). We now know that many cases of Lyme disease on the West Coast of the United States is caused by Borrellia miyomotoi, which does not get tested with the Western Blot. So, it is highly plausible that patients who experience Lyme disease symptoms and have a negative test may have a different strain that the test they engaged was simply not developed to detect. It is surprising that with everything we know about Lyme disease and the antibodies associated with it, the CDC has yet to alter its criteria to reflect the current research in 2020. Would you refer back to a 1990 TV guide for your new 2020 TV? NBC still exists, but you won’t exactly see new episodes of Miami Vice playing this Friday night.
There are also no official guidelines for tests that may be considered borderline or equivocal. There have been many patients tested using Western Blot that show 4 or less markers instead of the 5 required IgG bands or only 1 out of 3 IgM bands, but the presented antibodies that they do show are considered highly Lyme-specific and yet the patient receives no follow-up testing to confirm or refute these results.
Since the tests are actually measuring the number of antibodies, the cut-off for these tests assumes each patient exposed to Borrelia has nearly the same exact immune response. The CDC has failed to recognize the diversity of the human population and their unique immune responses. If someone is positive for a Lyme-specific antibody, yet they do not meet the CDC criteria for a positive result, does that mean they don’t have Lyme?
(1) Engstrom SM, Shoop E, Johnson RC. Immunoblot interpretation criteria for serodiagnosis of early Lyme disease. J Clin Microbiol 1995;33:419-22
(2) Dressler F, Whelan JA, Reinhart BN, Steere AC. Western blotting in the serodiagnosis of Lyme disease. J Infect Dis 1993;167:392-400
