论文部分内容阅读
高灵敏度抗-HBs固相放免试剂盒(以下简称“抗HBs RIA盒”)的系统研究为本所接受国家“七五”攻关课题之一,经五年研制结果表明,HBsAg质量可通过定量测定HBsAg活性蛋白含量提供高质稳定的原料,根据卫生部检定所国家标准品检定抗HBs RIA的科研试剂盒在敏感性、特异性及定量抗体检测的线性关系上均得到较好结果。中试后可稳定投产,临床验证与美国Abbott试剂盒比较,在质量上接近该种试剂的国际水平,该项国产试剂已达到国家级鉴定要求。
High sensitivity anti-HBs solid phase radioimmunoassay kit (hereinafter referred to as “anti-HBs RIA box”) system-based research by the country received “Seventh Five-Year” research topics, after five years of development results show that the quality of HBsAg can be determined by quantitative HBsAg protein content provides high quality and stability of raw materials, according to the Ministry of Health, the national standard test anti-HBs RIA research kit in the sensitivity, specificity and quantitative antibody detection of the linear relationship are better results. After the pilot plant can be put into operation steadily, clinical validation and the United States compared to Abbott kit, in quality close to the international level of reagents, the domestic reagents have reached the national appraisal requirements.