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筛选全国 14个省、市、自治区的 2 5 0 0 0多份血样 ,取其中 2 6 4份用国产 14种抗HCVEIA试剂 ,国外 2种第 3代抗HCVEIA试剂复检 ,用RIBAHCV 3.0和PCR试剂确证。经两轮会同标定 ,国外两个实验室复核 ,确定40份阳性、40份阴性样品组成第 3代丙肝试剂国家参考品。 40份阴性样品中包括国内外几十种试剂曾经出现过非特异假阳性反应的阴性样品以及其S C值较高的阴性样品。 40份阳性样品中 ,6 5 %为弱阳性样品 ,有的样品含有全谱的抗HCV抗体 ,有的样品含有某几种抗HCV抗体 ,有的样品以抗HCV某种蛋白抗体成分为主 ,还有的样品只含有某种特定的抗HCV蛋白抗体。该参考品已通过专家鉴定并经卫生部批准使用。经改进后达到第 3代参考品标准的国产试剂的临床考核说明 ,该参考品促进了国产试剂质量的提高 ,并达到国际先进水平。
A total of 2550 blood samples from 14 provinces, municipalities and autonomous regions of China were screened, of which 246 were made by domestic anti-HCVEIA reagents and 2 were re-tested by two third-generation anti-HCVEIA reagents. RIBAHCV 3.0 and PCR Reagent confirmation. After two rounds of calibration, the two laboratories in foreign countries reviewed and confirmed 40 positive samples and 40 negative samples formed the third generation of national hepatitis C reagent reference materials. The 40 negative samples included negative samples with non-specific false positives from dozens of reagents at home and abroad, and negative samples with higher S C values. Among 40 positive samples, 65% were weakly positive samples. Some samples contained anti-HCV antibody in the whole spectrum. Some samples contained several anti-HCV antibodies. Some samples were mainly anti-HCV antibody. Still other samples contain only one specific anti-HCV protein antibody. The reference has been certified by experts and approved by the Ministry of Health to use. After the improvement to reach the third generation of reference standard clinical evaluation of domestic reagents that the reference to promote the quality of domestic reagents to improve and reach the international advanced level.