丙型肝炎病毒抗体酶联免疫诊断试剂中酶结合物稀释液对酶结合物稳定性影响的研究  

Research on the influence of enzyme combination diluent on the stability of its product in diagnostic for antibody to hepatitis C virus(HCV)enzyme linked immunosorbent assay (ELISA)reagents

作　　者：宋惠娟[1] 向凌云[1] 史楠[1] 李成文[1] 李魁彪[1] 林兴兵[1] 曹友声[1] 

机构地区：[1]河南省科学院生物研究所河南理利生物工程有限公司,河南郑州450008

出　　处：《药品评价》2005年第5期351-353,共3页Drug Evaluation

摘　　要：目的通过对不同酶结合物稀释液的丙型肝炎病毒(HCV)抗体酶联免疫诊断试剂的稳定性对比试验,优选出最佳的酶结合物稀释液用于HCV抗体诊断试剂的生产。方法用不同酶结合物稀释液的HCV抗体酶联免疫诊断试剂,对丙型肝炎质控血清进行检测,检测出4℃试剂盒实验结果各样品S/CO值和37℃3d试剂盒实验结果各样品S/CO值,将实验结果进行对比。结果以中性PBST(加有Tween-20的磷酸盐缓冲液)为缓冲液,以BSA(牛血清白蛋白)和Casein(酪蛋白)无关蛋白作稳定剂的酶结合物稀释液的试剂的实验结果明显优于其余试剂。结论以PBST为缓冲液,以BSA和Casein无关蛋白作稳定剂组成酶结合物稀释液适用于HCV抗体酶联免疫诊断试剂的生产。Objective This paper is to screen out the optimal enzymatic combination diluent which is used in the production of diagnostic reagents for antibody to hepatitis C virus （HCV）. It is obtained through stability contrast experiments of HCV antibody enzyme of different enzymatic combination diluent for hepatitis C virus antibody enzyme linked immunosorbent diagnostic reagent. Methods The HCV control serum was detected by HCV antibody enzyme linked immunosorbent diagnostic reagents with different enzyme combination diluent. The specific value of S/CO of specimens was tested at 4℃ when they were in the reagent box, and the value was also tested at 37℃ 3 days later. All the experimenal results were contrasted with each other. Results The enzyme combination diluent that was composed of neutral PBST （phosphate buffered saline with Tween-20） as buffer liquid and BSA（bovine serum albumin） and Casein as stability is obviously better than other reagents. Conclusions The results indicates that enzyme combination diluent is suited for the production of HCV antibody enzyme linked immunosorbent diagnostic reagents,if the enzyme combination diluent regards PBST as buffer liquid and BSA and Casein irrelated albumen as stability.

关 键 词：HCV抗体 酶联免疫 酶结合物稀释液 稳定性 对比研究 

分 类 号：R446.6[医药卫生—诊断学]