第3代丙肝试剂国家参考品的研制及初步应用

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。

Preparation and Preliminary Application of The Third Generation of Na-tional Reference for Anti-HCV Diagnostic Kits

More than 25 000 serum samples were collected from 14 provinces, autonomous region and municipalities directly under the central authorities of China. Of the samples, 264 were retested by 14 kinds of anti-HCV EIA kits made in China and 2 kinds of the 3rd generation of the kits made in America, then confirmed by RIBA HCV 3.0 and PCR reagents. After 2 times of collabortive assignments by 16 Chinese and 2 American laboratories, 40 positive and 40 negative samples were selected out and used for preparing the 3rd generation of national reference for anti-HCV diagnostic kits. The reference has been evaluated by the expert commitee and approved by the Ministry of Public Health. Clinical trial proved that the reference promoted the improvement of the qualities of national kits and reached the international level.