On May, 2014, two more ELISA kits manufactured by Alkor Bio – “ToxoplasmaEIA IgG” kit for qualitative and quantitative detection of immunoglobulins G  to Toxoplasma gondii and  “ToxoplasmaEIA IgG Avidity” kit for detection of immunoglobulins G avidity to Toxoplasma gondii in the human blood serum and plasma – have received CE-mark. 

Audit for assessment of compliance with the requirement of European Directive 98/79/EC for In Vitro diagnostics medical  devices was conducted in February, 2014.  As the kits for diagnostic of Toxoplasma are included into the List B, Annex II of European Directive 98/79/EC, the Notified Body participation is required for their registration on the EC market. Lloyd`s Register LRQA, Great Britain, was involved in the audit as Notified Body, the independent  technical evaluation of the kits was conducted by Paul-Ehrlich-Institut, Langden, Germany. The audit results confirmed the compliance with all EC requirements established for such kits.  

“ToxoplasmaEIA IgG” and “ToxoplasmaEIA IgG Avidity” kits were registered by Health Department of Russian Federation before and used in the clinical laboratories throughout Russia. Now these kits can be used in the countries of European community also.   

Today Alkor Bio  - developer and manufacturer of the assay kits for immune-enzyme and molecular-genetic analysis – produces more than 60 different kits for In Vitro diagnostics and more than 50 kits are CE-marked.