Diagnosis of HIV infection: new test generation system Alcor Bio Roszdravnadzor have been registered in the Russian Federation

Just two new developments biotechnology holding company Alcor Bio — a test system for the diagnosis of HIV infection — have received a registration certificate Roszdravnadzor Russian Federation: "VichIFA-anti-HIV-1, 2" — a set of qualitative enzyme immunoassay reagents for the detection of antibodies to human immunodeficiency virus in serum and human blood plasma and "VichIFA-HIV-Ag/At" — a set of reagents for the qualitative determination of p24 antigen ELISA and antibody to human immunodeficiency virus in serum and plasma of human blood.

Clinical trials of new test systems for the diagnosis of HIV infection were conducted at the immunology laboratory of St. Petersburg GOOSE "Clinical Infectious Diseases Hospital im.S.P. Botkin, "Northwest Regional Center for Prevention and Control of AIDS NIIEM the Pasteur, the Federal Center of Heart, Blood and Endocrinology. VA Almazova. New Products Group Alcor Bio were compared to test systems for the world leaders. The tests showed a high degree of consistency of the results obtained on the test production systems Alcor Bio and reference test systems.

For the test-system "VichIFA-anti-HIV-1, 2" and "VichIFA-HIV-Ag/At" standard equipment can be used for enzyme immunoassay (as semiautomatic, or automatic), which is mainly equipped and Russian diagnostic laboratories.
A significant difference test systems fourth generation "VichIFA-HIV-Ag/At" from the test systems of the third generation "VichIFA-anti-HIV-1, 2," is that the test system of the fourth generation allows for earlier diagnosis of HIV infection . It is well known that antibodies to HIV appear in 90-95% of infected within 3 months after infection, at 9.5% — after 6 months from the time of infection, and 0.5 — 1% — at a later date. For early diagnosis of HIV — infection using a test system that determine not only the antibodies to HIV, but HIV-1 antigen p24. In most cases (but, again, not all), P24 appears in the blood after 1-3 weeks after infection and is an early marker of infection. At present and test systems for the detection of antibodies to human immunodeficiency virus, and test systems for the determination of p24 antigen and antibodies to human immunodeficiency virus are widely used for the diagnosis of HIV infection.

For reference, according to data obtained from various sources in the world today more than 40 million people are living with HIV. With the exception of Africa, the fastest today, HIV is spreading in Central Asia and Eastern Europe. From 1999 to 2002, the number of infected people is nearly tripled. These regions are constrained to an epidemic of the late 1990s, and then the number of infected has increased dramatically — mostly as a result of drug addiction. The first case of HIV infection in the Soviet Union was registered in 1986 by the end of 2009 in Russia there were 529,828 HIV — positive Russians (0.5% of the adult population aged 15-49 years) and 13 072 foreign nationals. The number of new HIV cases among Russian citizens in 2009 — 58 448.
In St. Petersburg, HIV testing is held annually about 550 million people, with an average detected from 3 to 4 million new cases of HIV — infection. It is clear that the new ones can only be called arbitrary, since contamination could have happened a few years ago. For comparison, in 2000-2001, in St. Petersburg, there were 20,000 HIV — infected people. If you extrapolate the data from medical studies on HIV to the general population of the city, it turns out that in St. Petersburg, about 1% of the population of HIV — infected.
For the record:
St. Petersburg company "Alcor Bio» http://www.alkorbio.ru/ was established in 1992. Over the years the Russian market "Alcor Bio" has formed around the largest in the Northwest biotech cluster www.alkorbiogroup.ru. The company is currently "Alcor Bio" occupies a leading position among the domestic development and production of reagents for laboratory diagnostics: Diagnostic hormone (adrenal and thyroid, reproductive, etc.), diagnosis of cancer, infectious diseases (rubella, herpes, hepatitis B and C, HIV, etc.), allergy (test system and more than 50 kinds of allergens). Among the companies in the North-West region, working in the field of medical biotechnology, "Alcor Bio" is the most technologically advanced, as evidenced by the company in implementing the quality management system ISO 9001:2008 and ISO 13485:2003. Every year, "Alcor Bio" produces more than 200,000 sets of reagents for more than 60 titles, most of them have European quality mark — the CE mark. All diagnostic preparations produced "Alcor Bio", registered and certified Roszravnadzorom Russia. Currently, "Alcor Bio" is developing about forty innovative projects in the field of high biotechnology. The total investment in these projects is 20 million. Almost all of the scientific development of the underlying projects have a world novelty, and they filed patent applications. Most of the innovative projects "Alcor Bio" develops at the expense of own funds.

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