中国仓鼠卵巢细胞表达的乙型肝炎病毒表面抗原含量质控参考品的建立  

Establishment of HBsAg quality control reference meterial expressed by Chinese hamster ovary(CHO) cell

作　　者：周海媚[1] 吴长龙[1] 

机构地区：[1]卫生部上海生物制品研究所,上海200052

出　　处：《中华实验和临床病毒学杂志》1996年第2期138-141,共4页Chinese Journal of Experimental and Clinical Virology

摘　　要：采用基因转染中国仓鼠卵巢细胞(CHO)表达的乙型肝炎病毒表面抗原建立质控参考品,为建立 HBsAg 酶标法诊断试剂盒实验室内部质量控制提供了保证。用直接非竞争酶联免疫检测法平行比较 HBsAg 质控参考品和卫生部药品生物制品检定所灵敏度参比血清(80ng/ml)的含量,结果表明两者的各点能相互重叠,说明二者的 HBsAg 含量相一致。将建立的 HBsAg 质控参考品与卫生部药品生物制品检定所参比血清相比较,在16～1ng/ml 浓度范围内各点能相互重叠,说明所配制的质控参考品的含量和线性均与卫生部药品生物制品检定所线性参比血清相一致。该质控参考品在37℃条件下能稳定35天。HBsAg quality control reference material has been established by Chinese hamster ovary(CHO)cell through genetic transfection.This method of preparing quality control reference metarial has the laboratory advan- tages of high stability,easy to obtain raw antigen,and no risk of contamination.The mean absorbance between HB- sag quality control reference metarial and sensitivity control reference material prepared by National Institute for the Control of Pharmaceutical and Biological Products is very similar,when parallelly tested by direct non-competitive testing with direct non-competitive ELISA method,the absorbances of diluted HBsAg quality control reference materi- al coincided with those obtained from series of official linearity reference serum.HBsAg quality control reference metarial is stable for 35 days at 37℃.

关 键 词：仓鼠卵巢细胞 乙型肝炎病毒 表面抗原 ELISA 

分 类 号：R512.62[医药卫生—内科学]