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The letters below were submitted to the NY Times in response to an article critical of medical laboratories specializing in tick-borne infections. The article promoted the notion that the CDC two-tier testing criteria for surveillance purposes should be used for diagnosis. It is well documented that the ELISA, the first-tier test recommended by the CDC, has poor reliability.
Quest has acquired American Medical Laboratories, Kaiser's contracted laboratory referenced in the letters. Kaiser sent their blood samples from West Coast facilities to the East Coast based American Medical Laboratories. By Kaiser's own study and verified by patient accounts, the results were almost always negative for Lyme disease.
NY Times
Letter to the Editor;
In the August 23, 2005 article "Unproved Lyme Disease Tests Prompt Warnings" Paul Mead of the CDC states the two-step testing protocol is accurate more than 90% for long-term Lyme infection.
A test by the CDC on highly positive banked blood samples showed the ELISA was only able to repeat two-thirds of the time. SmithKline’s vaccine clinical trial showed less than one-third with proven Lyme disease were able to meet the CDC’s restrictive surveillance criteria for Western Blot IgG. Using these two tests alone would miss 80% of Lyme disease cases.
In a study once referenced by the CDC, 117 samples of suspected Lyme disease from Kaiser Permanente in California were sent to American Medical Laboratories (now Quest) in Virginia. Only one ELISA was positive. I was a victim of flawed testing by AML - twice. Perhaps laboratories that can’t seem to find Lyme disease should be questioned as well.
Miguel Perez-Lizano
Letter to the Public Editor;
Re; Unproved Lyme Disease Tests Prompt Warnings
By Dan Hurley and Marc Santora
In the August 23, 2005 article titled "Unproved Lyme Disease Tests Prompt Warnings" Paul Mead of the C.D.C. states the two-step testing protocol is accurate in more than 90% of long-term Lyme infection. The two-tier tests are a non-specific ELISA followed by Western Blots IgM and IgG if the ELISA is positive. The Western Blots measure antibodies to the Lyme bacterium, some specific to Lyme disease.
A test by the CDC on their own highly positive banked blood samples showed the ELISA was only able to come up with a positive two-thirds of the time. The very large scale vaccine clinical trial by SmithKline showed that less than one-third of those with proven Lyme disease were able to meet the C.D.C.'s highly restrictive 5 band criteria for Western Blot IgG used for surveillance purposes. Using these two tests alone would miss over 80% of Lyme disease based on these studies. Factoring in the Western Blot IgM would result in an even higher figure of missed cases.
In another study no longer referenced by the C.D.C. , 117 samples of physician and patient suspected Lyme disease from a Kaiser Permanente facility in northern California where Lyme disease is endemic was sent to American Medical Laboratories in Virginia. Only one sample resulted in a positive. Quest has since acquired American Medical Laboratories. The West Coast has 12 known strains of the Lyme bacterium. Most of the Lyme tests are based on a single East Coast strain. This can result in false negatives. I, for one, was a victim of flawed testing by American Medical Laboratories - twice. Fortunately, six years before these tests I had the hallmark Lyme disease rash without knowing what it was at the time. Perhaps the laboratories that can’t seem to find Lyme disease should be questioned as well.
Miguel Perez-Lizano
Washington Lyme Disease Support Group