United States of America. The Food and Drug Administration has approved a simple, new blood test for Lyme disease that can be used in a doctor’s office. The test: PreVue B. burdorferi Antibody Detection Assay: Chembio Diagnostic Systems: provides results in an hour, enabling doctors to make a probable diagnosis more quickly than with laboratory tests and to start treatment with antibiotics immediately.
The test 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.
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 uses antigenic proteins developed by recombinant DNA techniques rather than whole cell Borrelia burgdorferi preparations used in current laboratory tests: a technique that allows for more accuracy.
Reference: FDA Talk Paper T99-10, 16 February 1999.