Borrelia 14kDa+OspC IgM ELISA

Borrelia burgdorferi, a bacterium of the Spirochaetaceae, is the ethiologic agent of Lyme disease (Borreliosis) being the most common disease in Europe and the USA transmitted by tics (Ixodes sp.). Lyme borreliosis is a multi-systemic disease with a broad spectrum of clinical symptoms. A typical symptom of the acute phase is the erythema chronicum migrans (ECM), often accompanied by flue-like symptoms. In later stages of the disease arthritis, carditis, as well as neurological and dermatological manifestations may occur. Lyme borreliosis can be treated with antibiotics in all stages. Therefore, a safe and sensitive laboratory diagnosis of Lyme borreliosis, also detecting the early stage of diseases, is of major importance, since an early treatment is most appreciated. IgM antibodies usually appear approximately three weeks after the infection, IgG antibodies after four to six weeks. The early immune reaction is mainly directed against the flagellin peptide (41 kDa) and the OspC (Outer surface protein C, 23 kDa) and is then spread on more and more bacterial proteins. In this test Borrelia burgdorferi-specific 14 kDa fragment of the flagellin is used as a recombinant protein for antibody binding. This recombinant, in E. coli produced flagellin fragment is found to be identical in all three subspecies of borrelia. Results of extensive comparative studies with ELISA, IFA and agglutination tests as well as Western Blot demonstrate that the 14kDa IgM ELISA shows a higher diagnostic specificity as well as an increased sensitivity for the early immune response in Lyme borreliosis. In addition to the recombinant 14 kDa flagellin fragment the native OspC protein is used as coating antigen in the IBL Borrelia 14kDa + OspC IgM ELISA. Usually the acute phase is indicated by high titers of IgM antibodies. High IgG titers with low or without IgM antibodies occur when borreliosis is subsiding (due to therapy or spontaneously) or during the chronic stage. The Borrelia IgM test can be used for the diagnosis of Lyme borreliosis in the acute and chronic stage of the disease both requiring a therapy. Patients with a subsided borreliosis which does not require therapy any more will not show positive results.