16S RNA Primers used as the new Milford (CT) Hospital Lyme Test
Mort Zuckerman
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Subject: 16S RNA Primers used as the new Milford Hospital Lyme Test
Date: Mar 30, 2010 9:34 AM
This test is correct and meets with
my approval.
Especially since the likes of Gary
Wormser and Yale's Robert Schoen use
these primers when they want to
find Borrelia spirochetes in
TICKS, but have never used them
in human studies (except when
Gary Wormser proved that treatment
upon tick bite failed in 2/9 cases):
http://wwww.actionlyme.org/PRIMERSHELLGAME.htm
Mark Klempner, when he excluded
DNA-positive patients from his
Chronic Lyme re-treatment study,
never reported which DNA primers
he used to determine "NO LYME in
THE CSF OF LYME PATIENTS, WHO
WERE EXCLUDED" from his "study":
http://www.actionlyme.org/MKLEMPNER.htm
Kathleen M. Dickson
http://www.actionlyme.org
http://www.relapsingfever.org
==================================
March 29, 2010 10:00 AM Eastern Daylight Time
Early Lyme Disease DNA Test Reported in Upcoming April Paper in
American Journal of Clinical Pathology
Connecticut team at Milford Hospital develops test to identify
patients with spirochetemia for swift treatment
MILFORD, Conn.--(BUSINESS WIRE)--Many of the more than 30,000 people a
year in the United States with suspected cases of Lyme disease
spirochete (bacterial) infection can now take a DNA test developed by
a Connecticut scientist/physician and his team that can quickly
determine if they test positive for Lyme spirochetes in their blood.
This is the first such early Lyme test available, and most insurance
companies have already agreed to cover the cost for their members.
“said Connecticut physician Sin Hang Lee, MD.”
The scientific medical paper about the advanced test will be printed
in the April 2010 edition of the “American Journal of Clinical
Pathology.”
“If people are infected with the Lyme spirochetes, and not treated
quickly, thousands may suffer for many years from the debilitating
effects of the disease. "But if, after infection, the bacteria are
identified without delay, the patient can be effectively treated and
totally cured," said Connecticut physician Sin Hang Lee, MD.
There have been other PCR tests for early Lyme disease. But this is
the first effective one using nested PCR for detection and DNA
sequencing to validate the molecular diagnosis, in clinical laboratory
medicine. DNA sequencing is accepted as the gold standard for
molecular identification, said Dr. Lee.
Dr. Lee, a pathologist, and his colleagues at Milford Hospital
(Milford, CT) have developed the first highly sensitive and specific
DNA test for the diagnosis of early Lyme disease before the
traditional serology lab tests become positive. If the clinician
awaits the rising Lyme disease antibody titers (which is normally the
case) to make a diagnosis, the diagnosis of Lyme disease may be
delayed, or even missed. The literature reports that up to 75% of the
patients with acute-phase Lyme disease are negative for the
characteristic antibodies, but in fact the percentage is higher, he
said.
Lyme disease is spread by black-legged ticks, also known as deer
ticks, and is most common in Connecticut, Massachusetts, Maryland,
Minnesota, New Hampshire, New Jersey, Delaware, Pennsylvania, New York
and Wisconsin, according to the Centers for Disease Control. The
spirochete bacteria enter the skin at the location of the tick bite.
After an incubation for 3-30 days, the bacteria travel through the
skin and may spread to lymph nodes or travel through the bloodstream
to other organs and other skin sites.
In technical terms, the new LoTemp® nested polymerase chain reaction
(PCR) method detects a genomic DNA of the Lyme disease-causing
spirochete in the blood, which is further validated by DNA sequencing.
It is the marriage of both that minimizes false-negatives to the
lowest possible and eliminates false-positives known to be associated
with other Lyme disease DNA tests. Symptomatic patients visiting the
emergency department or the walk-in center have the best chance for an
early diagnosis by this new test. The waiting for a scheduled visit to
the doctor’s office usually misses the window of opportunity in DNA
detection at the time when the bacteria are circulating in the blood
of the patient in early Lyme disease, but only briefly, said Dr. Lee.
Dr. Lee is also now collecting data and writing a second report for
publication with Jay Walshon, MD, chairman of Emergency Medicine at
Milford Hospital and Jessie Williams, MD, of the Milford Hospital Walk-
in Urgent Care Center, to summarize their experience. Milford is a
suburban city outside of New Haven, in southern Connecticut. The
region has about 600,000 people and is located less than an hour from
Old Lyme, from which Lyme disease was named.
Lyme disease is endemic in the suburban towns in and around the
Milford area, which although located by Long Island Sound, is also in
many areas heavily wooded. Dr. Lee’s group reported that 25-50% of the
engorged deer ticks removed from the human skin bites in this area
were found to be infected by the Lyme disease causing spirochetes,
Borrelia burgdorferi.
Although the new method based on the nested PCR technology is highly
sensitive in detecting Lyme spirochete DNA, a negative result still
does not rule out Lyme disease because spirochetemia is transient and
its time points in Lyme borreliosis vary from patient to patient, said
Dr. Lee.
Dr. Lee said, “untreated or inadequately treated patients may develop
tissue damages in the joints, the heart and the nervous system as a
result of the bacterial infection. Since there were no reliable
laboratory tests to confirm the clinical diagnosis, Lyme disease has
been both over-diagnosed and under-diagnosed. Erroneous over-diagnoses
of Lyme disease may cause unnecessary use of antibiotics which are
associated with serious undesirable side effects in certain patients.”
Every positive DNA test result at Milford Hospital is confirmed by DNA
sequencing, and the diagnostic signature sequence validated by the
GenBank database, said Dr. Lee. The GenBank is an on-line database of
publicly available DNA sequence data maintained by the National Center
for Biotechnology Information (NCBI), a part of the National
Institutes of Health (NIH).
The physicians at the Milford Hospital Emergency Center and Walk-in
Urgent Care Center, who see about 40,000 patients a year, usually
order the traditional antibody testing and the new DNA test for
patients presenting with Lyme disease-like symptoms. Most insurance
companies except Aetna will pay for the test. Patients and physicians
interested in information on this DNA test may call George Poole,
manager of Milford Medical Laboratory, at 203-876-4496.
"[Real] scientists are *fiercely* independent. That's the good
news."-- NIH's Top Fool, Anthony Fauci