第二代丙型肝炎诊断试剂质量控制参考品的建立

Estahhshment of a second generation of national reference panels of quahlity control for hepatitis C diagnostic reagents in China

为了更加全面、客观地检测国产丙型肝炎诊断试剂的质量，特别是对用于筛查献血员的诊断试剂进行严格的质量控制，在建立第一代丙型肝炎诊断试剂质控参考品的基础上，用雅培、联合生物技术公司、北京生物制品研究所等国内外试剂对４００份血浆进行检测，选出１９８份血浆，用多种试剂及不同的方法（酶联免疫吸附试验、免疫斑点试验、聚合酶链反应）对其进行了反复的核验，建立了我国第二代丙型肝炎诊断试剂质量控制参考品。用此参考品对国产试剂进行了检定并制定了相应的检定标准，此套参考品及检定标准已获卫生部批准。

y three different kinds of ELISA diagnostic reagents (UBI,ABBOTT Laborateries,National Se-rum and Vaccine Institute),the authors estimated antibodies to hepatitis C virus of nearly 400 plasma samples,from which 100 and 98 positive and negative samples have been selected.F urther comfirmatory testings such as RIBA,PCR and tests for antibodies to different proteins of hepatitis C virus(C,NS3,NS4 NS5)were made. Therefore the second generation of national referenee panels of quality conttol for hepatitis C diagnostic reagents have been established and national requirements set up by experiments.These panels being used in the examination tests for license release should effectively control the quality of domestic kits,consequently raise the possibility of screening blood donations to prevent transmission of PT一NANB.