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
|