At the beginning of December Alkor Bio Group has obtained CE-mark certificate for the new kit “TreponemaEIA-Total Antibodies”. It allows Alkor Bio Group to export this kit to the EU market.

This kit is intended for Qualitative Determination of Total Antibodies to Treponema pallidum in human serum, plasma and liquor.

Vera Yurgina, the head of EIA Laboratory’s group said: “TreponemaEIA-Total Antibodies kit is intended for screening. His advantages are: short time for analysis (30 minutes); good diagnostic characteristics for separating positive and negative samples; color indication – the color of hole with sample is different, so the assistant could see, where the samples and reagents already are, and avoid mistakes”.

As a reference Architect Syphilis TP test-system be Abbott were used during product development. Also the kit “TreponemaEIA-Total Antibodies” were compared with another test-systems of Russian developers such as Vector-Best, Diagnostic Systems (DS), Ekolab, Medico-biological union (MBU). The quality of the kit is high and has good comments from clients.

According to Rosstat in 2015 thirty-three thousand cases of syphilis were registered in Russia (to 6,2% less than in 2014).

Extra information.

CE-mark on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called “Product Directives”.