FDA
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T99-10                        Sharon Snider:      301-827-6242
February 16, 1999             
                              Consumer Inquires:  888-INFO-FDA

FDA CLEARS NEW TEST FOR LYME DISEASE

The Food and Drug Administration has cleared a simple, new blood test for Lyme disease that can be used in a doctor's office.

The test provides results in an hour at the point of care, compared to the standard laboratory tests which have to be performed in a lab, delaying test results. This means doctors will be able to make a probable diagnosis quicker and start treatment with antibiotics immediately.

The test, the PreVue B. burgdorferi Antibody Detection Assay, is intended to be used as the first step in testing people suspected of having Lyme disease. Positive results must be confirmed with a Western blot test done by a laboratory. Two-stage testing is recommended by the Centers for Disease Control.

Lyme disease is a bacterial infection spread to humans primarily by tick bite. It is the most common insect-borne infectious disease in North America and is a significant public health concern. The infectious agent in the disease is the spirochete Borrelia burgdorferi.

Lyme disease may have many different manifestations. It starts with a large, red rash at the site of the tick bite. Then flu-like symptoms may set in. It may affect the nervous system, and, in later stage, may be manifest by persistent arthritis.

Diagnosing Lyme disease can be challenging because the symptoms of flu, fatigue and joint pain are similar to those of a number of other conditions.

The new test, made by Chembio Diagnostic Systems of Medford, N.Y., uses antigenic proteins developed by recombinant DNA techniques rather than the whole cell B. burgdorferi preparations used in current laboratory tests. Antigenic proteins developed by recombinant DNA techniques allow for more accuracy.

FDA's clearance of the PreVue test was based on results of clinical studies conducted by the manufacturer at clinics and physician offices. PreVue accurately detected Lyme disease in 72 percent of one group of 120 blood samples, and 95 percent of another group of 42 blood samples. The test incorrectly identified Lyme disease in three percent of 100 blood samples in which it was not present. This "false-positive" rate is similar to that of laboratory tests for Lyme disease.

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