Two innovative elaborations of biotechnological group Alkor Bio – reagents kit «HepatitisIFA-HBsAg» aimed for qualitative & quantitative immunoenzymometric analysis of membrane antigen of hepatitis B & reagents kit «HepatitisIFA-HBsAg-confirming» aimed for immunoenzymometric conformation of antigen of hepatitis B virus – had at once gotten a registration certificate.

Unique «HepatitisIFA-HBsAg» reagents kit is the only native diagnostics kit, that allows to determine the quantitative amount of hepatitis B, which gives the ability to adjust the medical treatment. The essential advantage of foreign analogues, though the analogue is quite nominal, is customized for the automated epuipment for immunoenzymatic analysis, available all over the country in any diagnostic laboratory. At the same time foreign reagents kits require equipment for hemilumeniscence immunoassay, too expensive for most Russian healthcare facilities. 

The development of the test kits for hepatitis B was started in 2008 in Alkor Bio’s research department. In spring of 2011 test kits successfully passed the clinical testing & in October after all the necessary paperwork done got the registration certificate of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation.

Professor Mukomolov Sergey Leonidovich, head of Saint-Petersburg scientific-research institute of epidemiology & microbiology diagnostic laboratory of hepatitis B virus, European bureau of WHO advisor, Doctor of Medicine, had provided his feedback about the results of clinical testing of Alkor Bio’s reagents kits:

Reagents kits testing, which company Alkor Bio delivered us, went good. Hepatitis B virus had been detected only in those trials, where it really was present. This is very important, because a problem of false-positive results appears very often. «HepatitisIFA-HBsAg» showed itself altogether very well. The reagents kit was compared with the gold standard diagnostic panel by Abbott Laboratories, which is considered the best & most sensitive diagnostic panel all over the world, as well as the most expensive one. Test panels prepared in our laboratory had been analysed with the American diagnostic kit & Alkor Bio’s diagnostic kit at the same time. The results of analysis came out 100% identical.  It’s necessary to mention, that the reagents kits were ciphered, so that laboratory assistants could not know what was inside. When we deciphered the results they were equal. It is also important that all the bioprobes used for testing came from our bank, both, positive & negative ones. We were also happy to find out that all the positive resulted trials in «HepatitisIFA-HBsAg» test were as well positive for «HepatitisIFA-HBsAg-confirming» test. This means that the developed test kit «HepatitisIFA-HBsAg» for qualitative & quantitative immunoenzymometric analysis of HBsAg has a high level of sensitivity & specificity. The quantity of HBsAg in analyzing trial showed a good correlation of the results (r=0.99). Hence reagents kit «HepatitisIFA-HBsAg» by Alkor Bio can be recommended for extensive use in clinical practice for screening, monitoring of therapy results & clinical course of hepatitis B virus.