Florida lab claims to have superior Lyme disease test
Test, however, is non FDA-approved, and Dr. Tim Lepore is skeptical
BY MARY LANCASTER INDEPENDENT WRITER
AFlorida laboratory facility maintains that for the last year it has been able to offer a blood test that specifically identifies whether a person is carrying the antigen or bacteria that causes Lyme disease. It is a test company principals claim is superior to the standard Western Blot test routinely run to search for antibodies that may appear after someone is exposed to the bacteria.

"The bacteria itself is extremely hard to find, which is why it has taken a year to get this test into use," said Thomas Long, President of Central Florida Research, Inc. based in Lake Alfred, Fla. Long contacted The Independent following its cover story on tick and Lyme disease published on Dec. 5.

"No one else in the United States has a test for the bacteria itself through blood processing. Florida is the only state to approve a test of this kind. Western Blot is sketchy in accuracy and not everyone hit with this bug creates antibodies," he said. "The benefit of this test is that it tells the doctor earlier and definitively if we see bacteria or not in the blood."

Not everyone is as enthusiastic about this testing method as Long, however.

"There are a number of bogus tests out there," said Nantucket physician Dr. Tim Lepore, who has treated scores of islanders with debilitating tickborne diseases. "This is not an FDA (Food and Drug Administration) approved test. And where is the test described in a referee [medical] journal?"

Long, standing by his laboratory's work, confirmed that the test is not FDA approved. While he also said no articles about the test have been published in medical editions, he noted that on January 1 the facility's medical director, Dr. Clifford Threlkeld, will be distributing a paper on the test for peer review.

At this time, the test, formally called Identification and Quantification of Borrelia Burgdorferi by Flow Cytometry, only indicates the presence of Lyme bacteria. Long said the lab is working on tests to show the presence of bacteria for babesiosis and ehrlichia that he anticipates will be ready to submit for state approval next spring. Still, he said he has confidence in his facility's current clinical test as a means to spot Lyme bacteria infection in its earliest stages to allow treatment before the disease gains a foothold in a person's body. The drawback to the test, said Long, is that it is not particularly effective in finding late phase Lyme after the bacteria has left the bloodstream and has entered tissue and spinal fluid. Generally, he said, the test is most useful when done between the time bacteria appears in the blood about a month after infection, when a patient shows potential disease symptoms, and up to three or four years after those occurrences.

Although the test is not FDA approved, Long said it has been measured against Western Blot and other methods to obtain its validity, and that any doctor from any state except New York State, which has different licensing laws, may contact the laboratory to arrange for blood tests to be run for the presence of Lyme.

"Nobody knows we're here," he said, explaining that the lab was founded 10 years ago as an outgrowth of work done by former hematologist Dr. Joanne Whitaker and until a year ago was known as

Bowen Research. I