Lyme Disease Diagnostic Products Introduced in Europe

New Lyme disease enzyme immunoassay (EIA) products have been introduced into the European market.

Lyme disease is caused by a Borrelia spirochete, which is transmitted by a deer tick. It is the most common tick-borne disease in the EU. The most frequent symptoms include skin rash, diffuse flu-like reaction, and joint pains. Diagnosis can be difficult because the characteristic rash is not always present. If untreated or inadequately treated, serious neurological, cardiac, or joint abnormalities can follow. Eurosurveillance reports that the incidence of Lyme disease is increasing across Europe with particularly high increases seen in Northern and Eastern Europe.

Produced by Trinity Biotech (Bray, Ireland), the products include European Union (EU) Lyme immunoglobulin (IgG) + variable surface antigen (VlsE) EIA and the EU Lyme IgM EIA. They are qualitative serological tests for the detection of IgG and IgM antibodies to the most prevalent and clinically important Borrelia species in Europe, i.e. Borrelia afzelii, Borrelia garinii, and Borrelia burgdorferi. The new products will be used as screening assays for Lyme disease in clinical laboratories.

The addition of VlsE significantly boosts the sensitivity of the assays. VlsE is an outer surface lipoprotein of Borrelia burgdorferi that undergoes antigenic variation through an elaborate gene conversion mechanism and is believed to play a major role in the immune response to the Lyme disease Borrelia.

The continued expansion of this market segment in Europe is driven by factors that increase exposure to ticks. There is more participation in outdoor activities such as hiking, hunting, and fishing; recent milder winters have contributed to the proliferation of tick numbers with a consequent increased incidence of Lyme disease.

Trinity Biotech specializes in the development, manufacture, and marketing of diagnostic test kits that are used in the clinical laboratory and point-of-care segments of the diagnostic market to detect infectious diseases, sexually transmitted diseases, blood coagulation, and autoimmune disorders. The new products complete Trinity Biotech's product offering for Lyme disease in Europe, complementing the existing EU Lyme Western Blot confirmatory assays.


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