静注人免疫球蛋白(pH4.0)中病原体检测方法的适用性研究  

Study on the Applicability of Pathogen Test Method for Intravenous Human Immunoglobulin (pH 4.0)

作　　者：柯兵兵 王德蓉 但晓梦 杨玉娇 谢育媛 姜红 郭江红 Ke Bingbing;Wang Derong;Dan Xiaomeng;Yang Yujiao;Xie Yuyuan;Jiang Hong;Guo Jianghong(Hubei Institute for Drug Control,Hubei Engineering Research Center for Drug Quality Control,NMPA Key Laboratory of Quality Control for Blood Products,Wuhan 430073,China)

机构地区：[1]湖北省药品监督检验研究院,湖北省药品质量检测与控制工程技术研究中心,国家药品监督管理局血液制品质量控制重点实验室,武汉430073

出　　处：《中国药师》2022年第6期1102-1107,共6页China Pharmacist

摘　　要：目的:探讨静注人免疫球蛋白(pH4.0)中HBsAg、HCV抗体、梅毒抗体、HIV抗体以及HBV-DNA/HCV-RNA/HIV-RNA检测方法的适用性。方法:向全国血液制品生产企业发放调查问卷,了解成品中病原体检测方法的基本情况。在静注人免疫球蛋白中加入不同浓度的HBsAg、HCV抗体、梅毒抗体、HIV抗体以及HBV-DNA/HCV-RNA/HIV-RNA阳性标准品,考察不同pH、不同稀释度条件下对上述病原体标志物的检出影响。结果:不同生产企业的HBsAg、HCV抗体、HIV抗体检测方法各不相同。经过加标考察试验,确定由于静注人免疫球蛋白的抗体中和活性,在成品中无法检测出HBsAg。测定静注人免疫球蛋白中HCV抗体时,筛选合适的试剂盒后,无需稀释即可测定出样品中的HCV抗体,或者将静注人免疫球蛋白pH调节至中性后进行测定。检测静注人免疫球蛋白产品中梅毒抗体、HIV抗体时,需将供试品的pH调节至中性(如pH7.4);检测HBV-DNA/HCV-RNA/HIV-RNA时,无需对样品进行特殊处理。结论:本研究建立了静注人免疫球蛋白上述病原体标志物统一检测方法,为血液制品的病毒安全奠定了基础。Objective: To investigate the applicability of HBsAg, HCV antibody, syphilis antibody, HIV antibody and HBV-DNA/HCV-RNA/HIV-RNA detection methods for intravenous human immunoglobulin(pH 4.0). Methods: A questionnaire was distributed to blood product manufacturers nationwide to know the situation of pathogen detection methods for finished products. Different concentrations of HBsAg, HCV antibody, syphilis antibody, HIV antibody and HBV-DNA/HCV-RNA/HIV-RNA positive standards were added to intravenous human immunoglobulin to investigate the effects of different pH and dilutions on the detection of the above pathogen markers. Results: The detection methods for HBsAg, HCV antibody and HIV antibody were various among different manufacturers. Through the spiking test, it was determined that HBsAg could not be detected out in the final product of human immunoglobulin for intravenous injection due to antibody neutralizing activity. For the determination of HCV antibody in intravenous immunoglobulin, after screening the appropriate kit, HCV antibody in the samples could be determined without dilution, or when the pH of intravenous immunoglobulin was adjusted to neutral before determination. For the detection of syphilis antibody and HIV antibody in intravenous immunoglobulin products, it was necessary to adjust the pH value to neutral(such as 7.4);when HBV-DNA/HCV-RNA/HIV-RNA was detected, no special treatment was required for the samples. Conclusion: In this study, a unified detection method was established for the above pathogen markers in intravenous human imnunoglobulin, which lays foundation for the viral safety of blood products.

关 键 词：乙型肝炎病毒表面抗原 丙型肝炎病毒抗体 梅毒抗体 人类免疫缺陷病毒抗体 酶联免疫吸附试验 

分 类 号：R917[医药卫生—药物分析学]