METHOD FOR MAKING OPERATIONAL STANDARD OF SERUMS CONTAINING ANTIBODIES TO HEPATITIS C VIRUS Russian patent published in 2010 - IPC G01N33/576 G01N33/53 A61K39/42 

FIELD: medicine.

SUBSTANCE: method includes certification of serum samples for observed antibodies to hepatitis C virus to assess availability thereof as an operational standard. The serum samples are certified by immunobiological markers of HBs antigen, hepatitis C virus antibodies, HIV types 1, 2 and anti-HBs, anti-HBc, anti-HBe antibodies, and by the biochemical properties: enzyme level, total protein, pH. The immune-specific samples are serums containing RNA of hepatitis C virus and positive results of the immune-enzyme assay ("ОП<ОПкр."), negative plasma samples of "ОТ" - PCR with "ОП<ОПкр." The operational standard represents a complete set of negative and a number of positive serums containing various types of antibodies to hepatitis C virus.

EFFECT: according to the invention, the methods allows making the operational standard containing serums close to the human native serums, and also assessing the quality of each antigen: core, NS3, NS4 and NS5, used in development of the immune-enzyme test systems for detecting antibodies to various proteins of hepatitis C virus, storing and handling the operational standard at higher temperatures.

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