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Lyme Testing: The Problems Rarely Appreciated

Many good and sincere physicians have been trained to perceive Lyme testing falsely, and some are even infectious disease consultants.

Lyme is a very sophisticated bug. It is partially related to the bug that causes syphilis. There are literally well over a dozen reasons for missing the diagnosis.

First, that bulls eye rash is a good sign you have it. But many other "bite" patterns or rash patterns can also be Lyme. In fact only 1/2 get any kind of mark or rash. And only 25-50% have the popular bulls eye rash. Sometimes a bulls eye rash is not on a part of you body you easily see and so is missed.

  1. Lyme can hide by a number of ways from your immune system.
  2. It your immune system is not tuned up and working very well you can be found fully negative on multiple lab tests.
  3. Most tests for Lyme are antibody tests. Antibodies, also known as immunoglobulins, are proteins that recognize something foreign in the body—like infecting bacteria and help remove it. The first and most common test your doctor usually orders is an ELISA antibody test. Again, if the Lyme is hiding well or your immune system is fair, you will come up normal. Specifically, the ELISA test missed 56% of confirmed Lyme patients (Archives of Internal Medicine 15:761-0763, 1992).

    In another study, it was in some ways worse. In this one the ELISA test missed over 70% of people with early Lyme disease, and 46% with late manifestations of Lyme. (Laboratory Medicine 21:299-304, 1990). Meaning, it missed 70 out of 100 people with the early disease. But it was still negative after the bug was in the body for a long time -- still missing 46 of 100 seriously infected people.
  4. For some, the Lab is a place of perfect science. A place which has purely objective fact. In Lyme this is not valid. In one study, 55% of the labs could not accurately identify blood samples with Lyme, which led to the conclusion in a prestigious infection journal, that: screening tests for Lyme disease are not adequate (Journal of Clinical Microbiology 35:537-543, 1997).
  5. What About the Western Blot? Is That Definitive?

    The Western Blot is merely another antibody test. However, it is more specific than the ELISA. The test can test for 25 possible "bands" that relate to parts of Lyme or other infections.

    But the routine Western Blot typically done has massive errors. In one serious test of the Lyme Western Blot testers, there was a stunning finding. They used nine clearly infected patients and sent their blood to 18 labs. Of the IgG type of antibody, some labs were wrong. They missed 10 of 18 samples. For the IgM type of antibody, the labs were occasionally so bad they falsely reported Lyme as absent in 16 of 18 samples (Arch Intern Med 150:761-763, 1990).

    1. Most physicians are taught to do the ELISA first. If that is positive then "confirm" with the Western Blot. The big confusion is that this is not a way to diagnose. It is the CDC's way of generally tracking the movement of Lyme in locations and states. It is not a way to determine whether you, personally, have Lyme!

      If you use the Elisa first method with the confirmation Western Blot you miss massive numbers of individuals with Lyme (Journal of Clinical Microbiology 34: 10-9, 1996). From this two-stage approach, you may have a sense that Lyme is entering your state at an increased rate, but that does not address your individual concern.
    2. The CDC guidelines seem to express clearly to me that these two lab tests were never intended to be the final measure of whether you have Lyme. They report the main diagnostic criteria are what you report to your doctor and what they find on a physical, i.e., "clinical findings." (https://www.cdc.gov/ncidod/dvbid/lyme/diagnosis.htm)
    3. Another government agency, the conservative FDA, has issued a bulletin explaining that a person may have active Lyme disease and yet may have a negative lab result. Meaning, diagnosis should be based on the history of what happened to you, symptoms, exposure to the tick and physical findings (https://www.fda.gov/medbull/summer99/lyme.html).
    4. Congress and the President have felt that negative labs have been used to keep people from needed treatment. United States Congress Public Law 107-116 explains that labs that are negative have no relation to Lyme diagnosis in a person and refers to the CDC that lab monitoring and testing with Elisa and Western Blot was "developed for national reporting of Lyme disease: it is not appropriate for clinical diagnosis."

    Some bands may be fairly specific to Lyme: 12, 22, 23/25, 31, 34, 35, 37, 39, 83

    Finally, some feel the PCR test is the best test. Most PCR tests are performed by laboratory which almost never find it in positive people. However, the PCR test should be done by IGeneX, Medical Diagnostic Labs or another tick disease specialty lab, it is fairly useless. PCR testing can have a false negative of 30% in those with positive Lyme. It is also good to test the PCR from blood serum, whole blood and urine, so they have more ways to look for the illness.

    Excerpts from a book in manuscript by: Dan Kinderlehrer, MD.

    Dr. Kinderlehrer has been a great help to many of my patients, and I deeply appreciate his willingness to share these thoughts. His book is very comprehensive. It will be a major contribution to Lyme care.

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