The two latest innovative elaborations of biotechnological group Alkor Bio – reagents kits for HIV infection diagnostics got registration certificate from Federal Service on Surveillance in Healthcare and Social Development of Russian Federation. The «HivEIA-anti-HIV-1,2» diagnostic kit is intended for qualitative immunoenzymometric analysis of antibodies for human immunodeficiency virus in serum & blood plasma. The «HivEIA-HIV-Ag/Ab» diagnostic kit is intended for qualitative immunoenzymometric analysis of antigen P24 & antibodies for human immunodeficiency virus in serum & blood plasma.
Clinical tests took place in the laboratories of immunology in Saint-Petersburg Clinical Isolation Hospital n.a. S.P. Botkin, Pasteur Institute of Epidemiology and Microbiology, Federal heart, blood & endocrinology center n.a. V.A. Almazov. The new diagnostic kits had been compared with the similar test-systems produced by the worldwide leaders of the field. The tests proved high rank of match of the results collected with Alkor Bios & referential test-systems.
Tests with the use of «HivEIA-anti-HIV-1,2» & «HivEIA-HIV-Ag/Ab » can be run on basic equipment for immunoenzymometric analysis, both, automanual & automatic, which is available in typical Russian diagnostic laboratory.
Essential difference of the forth-generation test-system «HivEIA-HIV-Ag/Ab » from the third-generation test system «HivEIA-anti-HIV-1,2» is the ability to use the forth-generation test system for early diagnostics of HIV infection. It is known, that 90-95% of adult patients carry antibodies for HIV for about 3 months after being infected, 5-9% of newborns carry antibodies for HIV for 6 months after being infected & 0.5-1% for even longer. For early diagnostics of HIV infection test-systems for diagnostics of not only HIV antigen, but also HIV-1 P24 antigen is needed. In most cases (but not in all of them) P24 occur in blood after 1-3 weeks after being infected & are taken as a marker of the infection. Nowadays both third-generation & forth-generation test-systems are used for diagnostics of HIV.
About 550 thousand people are being examined for HIV each year, at the same time about 3-4 thousand of new cases of HIV are found. It is obvious that they can be called new only nominally, because the fact of introduction of infection could have happened even couple years before that. For comparison: in 2000-2001 about 20 thousand people were diagnosed with HIV in Saint-Petersburg, which is about 1% of the city population.