Early Lyme Disease DNA Test Reported in Upcoming April Paper in American Journal

[Guest guest]

Early Lyme Disease DNA Test Reported in Upcoming April Paper in American

Journal of Clinical Pathology

_http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view

& newsId=20100329005235 & newsLang=en_

(http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view & new\

sId=20100329005235 & newsLang=en)

 

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.

 

 

The scientific medical paper about the advanced test will be printed in the

April 2010 edition of the “American Journal of Clinical Pathology.â€

 

 

“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_

(http://cts.businesswire.com/ct/CT?id=smartlink & url=http://ajcp.ascpjournals.org\

/content/133/4/569.abstract & esheet=6229

677 & lan=en_US & anchor=DNA+test+for+the+diagnosis+of+early+Lyme+disease & index=

1 & md5=a65a96247fbb51844b54e102904411c4) 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 t

hat 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.

 

 

Contacts:

 

For Milford Hospital

Ken Warren, 203-891-9001