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 stages, 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. The Food and Drug Administration. FDA Clears New Test for Lyme Disease .