Construction of reference panel of immune serum against hepatitis C virus with standard level of IgG antibodies

: A panel of anti-HCV sera (lot 03HC) was prepared from human sera obtained at blood transfusion centers and infectious hospitals. Donor sera and high-titer sera from patients infected with HCV were used. For positive samples, specific sera reactive with the core and/or NS proteins of HCV 1b and 2 were selected. Positive sera were standardized by the concentrations of IgG with a pool of negative sera containing no HBsAg and antibodies to HIV, HCV, and syphilis. The sera for the panel were selected and titered in screening and specific tests. The anti-HCV panel includes negative and positive sera with low and high titers. The panel sera are stabilized and can be stored for a short time at room temperature. The anti-HCV panel of sera, lot 02HC, was certified at L. A. Tarasevich Institute for Standardization and Control as anti-HCV reference panel intended for sensitivity, specificity, and stability control of diagnostic systems for detection of antibodies to HCV in Russia.