Novel Multiplex Test for Lyme Disease

Lyme Disease (LD) is caused by spirochetal bacteria from the genus Borrelia. Borrelia burgdorferi is the predominant cause of Lyme Disease in the United States, whereas Borrelia afzelii and Borrelia garinii are predominantly implicated in most European incidences. The CDC reported 28,921 confirmed US cases of LD in 2008, presenting a 5% increase of confirmed cases in comparison to 2007. It is estimated that 2.5 million serological LD tests are performed annually.

Recommendations by the CDC for the diagnosis of LD include a two-tiered approach: an initial ELISA-based screening test in conjunction with western blotting to establish the presence of anti-Borrelia antibodies. Currently available LD tests are not only time-consuming, but also display a high probability of false-negative and/or positive results. To address this problem, we cloned, expressed and purified 14 Borrelia-specific antigens for use in the development of a highly sensitive handheld point-of-care (POC) multiplex diagnostic device capable of detecting anti-Borrelia-specific IgM and IgG antibodies in human serum. These 14 antigens, expressed during different stages of the disease, are used to probe LD positive and negative human sera and to raise antigenspecific antibodies. Here we present the preliminary data in our efforts to develop a POC testing device for LD.