DEVELOPMENT OF TEST KIT FOR DETECTION OF PANDEMIC STRAIN INFLUENZA VIRUS A (H1N1 2009) BY REAL TIME POLYMERASE CHAIN REACTION

Influenza viruses A play an important role in the structure of the incidence of people with acute respiratory viral infection, which make up 90% from all other infectious diseases. According to the World Health Organization, only severe flu worldwide suffer annually 3.5 million, of which 45?60% are children. An economic loss from seasonal flu epidemic is in average about 85% of economic losses from infectious diseases in general. The experience of fighting the flu, accumulated over the years, has shown that to develop and deliver effective preventive measures necessary to build a system of permanent monitoring for influenza virus circulation, based on use of laboratory methods for accurate and rapid dentification and characterization of circulating strains of influenza virus A. Among the methods of laboratory diagnosis of influenza, the most effective is a method of polymerase chain reaction. Data on the evelopment of diagnostic test kits in the format of two-stage multiplex RTPCR-analysis for detection and genotyping of pandemic influenza virus A (H1N12009) are given. The results of laboratory and experimental research of ?DIA Influenza H1N1? test system showed that it is effective and specific for detection of California pandemic influenza virus A (H1N12009) strains and can be used to diagnose disease caused by this strain of virus. Clinical trial of the course of the State registration by Ministry of Health of Ukraine have shown sensitivity and specificity of ?DIA Influenza H1N1? test systems up to 100%.