CLIA Borrelia recombinant IgM

• Screening test for the detection of IgM antibodies to Borrelia burgdorferi sensu lato
• Disease stage specification
• Intended for human serum, plasma
• High specificity and sensitivity achieved by a sophisticated combination of recombinant antigens fitting the IgM class antibody response

Lyme disease (Lyme borreliosis, LB) is a tick-borne bacterial disease caused by spirochete Borrelia burgdorferi with polymorphic clinical manifestations (cutaneous, rheumatological, and neurological). Early localized, early disseminated, and late disseminated infection stages of LB are characterized by different clinical symptoms. The later the stage, the more severe clinical manifestation and curing difficulty.

The diagnosis of the disease is based on anamnesis, clinical picture, and results of laboratory tests. At present, all European and North American guidelines (e.g. NICE, EFNS, and CDC) indicate that the laboratory diagnosis is based on a two-tier serology starting with immunoassay screening of specific IgG and IgM class antibodies, and subsequent confirmation of the antibodies to specific antigens by means of immunoblot. Serological diagnosis of borreliosis is difficult regarding the large genetic diversity of the species Borrelia burgdorferi s.l., possible cross-reactivity with unrelated antigens, by different individual serological reactivity, possible slow production of antibodies in the early phase of the disease, and on the other hand very long persistence (even tens of years) of the IgG and IgM antibodies in circulation.

Detection of intrathecal antibody production, necessary for the diagnosis of early and late neuroborreliosis (EFNS guidelines) is a special section of the LB diagnostics.