CLIA Borrelia

Chemiluminescence kit for the detection of IgG or IgM antibodies to Borrelia in human serum or plasma.

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 the medical history, clinical picture, and results of laboratory tests. At present, all European and North American guidelines (e.g. NICE, EFNS, and CDC) indicate 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 through 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.

Produkte

100 tests
Article no.: 71010 Request
100 tests
Article no.: 71009 Request

Advantages

  • Screening tests for the detection of IgG or 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 IgG or IgM class antibody response
  • The kits are CE-IVD certified and intended for professional use
  • For each CLIA kit a corresponding control set is available
Assay time 30 min
Assay stability 30 days in-board-stability / in-use-stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume 10 µL
Measuring range 5 - 700 U/ml (IgG), 5-100 U/ml (IgM)
Assay/kit content Reagent Cartridge with specific reagents for the assay, magnetic particles, calibrators