METHOD OF PREPARING STANDARD PANEL OF SERA TO CONTROL QUALITY OF TEST SYSTEMS AND IMMUNOBLOTS USED FOR SEROLOGIC DIAGNOSTICS OF ANTIBODIES SPECIFIC FOR VIRAL INFECTIONS Russian patent published in 1998 - IPC

FIELD: biotechnology and immunology. SUBSTANCE: immunospecific sera containing antibodies specific for viral antigens and having different concentrations of these antibodies are selected as well as set of native donor sera with zero titer. Sera for panels are selected after their investigation by technique of polymerase chain reaction to reveal infective material and titration in enzymatic immunoassay. Those sera are selected as immunospecific which exhibit regular decrease in optical density value in enzymatic immunoassay and analytical signal value in polymerase chain reaction test. As native donor sera with zero titer, those sera are selected having minus result in polymerase chain reaction test and optical density value below critical in enzymatic immunoassay. Selected immunospecific sera are diluted with diluent, containing no antibodies specific for virus being tested, to produce different concentrations of antibodies. In particular, immunologically inactive serum is used as diluent and all panel sera are supplemented with stabilizer. Samples of specific sera are additionally attested for content of some forms of antibodies by using enzymatic immunoassay with corresponding antigens of virus being investigated or using immunoblot. After that, such minimum number of sera are selected as standard for panel, which provides complete spectrum of antibodies corresponding to principal antigens of virus. To form standard panel, selected are: 25-30% of sera with zero titer, at least 50% of sera with titer from 1:100 to 1:200, and no more than 20-25% of sera with titer higher than 1:400, summary number of standard panel sera being at least 24. EFFECT: increased degree of controlling sensitivity of test systems and possibility of controlling their specificity. 6 cl, 1 dwg, 2 tbl