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The CDC's Confusing Approach to Lyme Disease Testing:
Their Approach Missed My Children

The Center for Disease Control's (CDC) position on diagnosing Lyme disease (LD) is an oversimplification of a complicated clinical condition. The CDC's two-tiered approach—where one first uses an ELISA lab test and only if positive does one order an IgM and IgG Western blots—potentially misses more than 40% of the patients. One year after the tick bite, this percentage may be greater than 50%. This is profoundly unacceptable for a serious spirochete bacterial infection.

This two-tiered protocol [ELISA first and then Western Blot testing] was developed from studies using Lyme patients presenting with the Erythema Migrans (EM) rash [the Bull's Eye rash] and arthritis or neuroborreliosis [Brain Lyme]. However, not all Lyme patients have these symptoms. Indeed, Lyme can infect any organ and presents with a vast array of signs and symptoms. In one of the NIH-sponsored studies, blood was taken from Lyme-suspected patients every two weeks for a period of four months, and any positive event (defined by the presence of 5 of the 10 bands by IgG Western blot) qualified the patient. In contrast, other NIH-sponsored research indicated that many defined Lyme patients did not meet the CDC Western blot criteria (the presence of 5 of the 10 bands), and that the IgM response which was thought to only matter in early infections was in fact a useful predictor of infection at all stages of disease including late chronic infections.

Lyme disease is a problematic diagnosis. The position adopted by the CDC makes it more complicated. Many patients do not elicit an antibody response great enough to be positive by currently available ELISA assays. In fact, studies conducted by the group responsible for Lyme Disease proficiency testing for the College of American Pathologists (CAP) concluded that the currently available ELISA assays for Lyme Disease do not have adequate sensitivity to be part of the two-tiered approach of the CDC/ASPHLD, where only ELISA-positive samples can be tested by Western blotting. Furthermore, if patients are treated early with antibiotics, their antibody response may be reduced or curtailed. In addition, initial mild flu-like symptoms may be overlooked. Later, if the symptoms return, most of the antibody markers may have disappeared. Dr. Robert Bransfield has shown over 20 ways Lyme evades the immune system and can have false testing when a patient is infected. The fact Lyme has more plasmids to beat the immune system then any other known bacteria should cause the CDC to be careful with simple lab testing approaches.

Aguero-Rosenfeld et al. showed that only 70% of the documented Lyme patients in their study had a significant antibody response. They suggested that the degree of antibody response might be related to the length of time the Bulls-Eye rash persists. They also reported only 64% of those with early appearing IgM antibodies went on the develop later stage two IgG antibodies, and yet one often hears IgG is the only antibodies that matter according to some infection physicians.

The reason that most ELISA assays are inadequate as screening tests is that they were not designed by the manufacturers to be sensitive at the 95% confidence level, the level typically required for screening. Screening tests cannot miss many positive cases and in some Lyme cases that have been missed by ELISA's patients have developed strokes, seizures, Parkinson-like symptoms, MS-like lesions, arthritis, psychiatric trouble and many other serious medical problems.

Luger and Krause found up to a 56% false-negative rate (depending upon the commercial kit), when compared to their clinical diagnoses in which they were confident the patient had Lyme disease. Golightly et al. observed a lack of sensitivity (over a 70% false-negative rate) with commercial kits in early Lyme disease and from 4 to 46% with late manifestations of Lyme disease. Thus, independent of the ELISA results, using both IgM and IgG Western blots may improve laboratory detection of LD.

For more information go to: www.ilads.org and read Position Paper: ILADS' Position Paper on the CDC's Statement Regarding Lyme Diagnosis.

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