Borrelia IgM recombinant ELISA, 96 wells

INTENDED USE
Enzyme immunoassay for the in-vitro semi-quantitative or quantitative determination of IgM antibodies against the 14 kD
and OspC antigens of Borrelia burgdorferi in human serum, plasma and CSF. Infections with all three B. burgdorferi
subspecies (garinii, afzelii and senso strictu) are detected.

SUMMARY
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 14 kD region of the flagellin and the OspC (Outer surface protein C)
and is then spread on more and more bacterial proteins.
In the Borrelia burgdorferi 14 kD + OspC IgM ELISA the Borrelia burgdorferi-specific part of the flagellin is used as a
recombinant protein for antibody binding. The results of extensive comparative studies with ELISA, IFA and
agglutination tests as well as Western Blot demonstrate that the 14 kD IgM ELISA shows a higher specificity as well as
an increased sensitivity for the early immune response in Lyme borreliosis. In addition to the recombinant 14 kD protein
the native OspC protein is used as coating antigen in the DRG Borrelia 14 kD + 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.