乙型肝炎表面抗原血清标准物质的研究  

Establishment of the first reference materials for hepatitis B surface antigen immunoassay

作　　者：王露楠[1] 邓巍[1] 张瑞[1] 申子瑜[1] 陈文祥[1] 李金明[1] 

机构地区：[1]卫生部北京医院 卫生部临床检验中心,100730

出　　处：《中华检验医学杂志》2007年第8期858-862,共5页Chinese Journal of Laboratory Medicine

摘　　要：目的研制国内用于 HBsAg 检测的血清标准物质。方法用 HBV 血清学标志物、抗-HCV、抗-HIV 均为阴性的献血员血浆,混合均匀,将 HBsAg 阳性血浆稀释至含量约40 IU/ml,然后进行真空冷冻干燥。检测方法采用电化学发光(ECLA)、化学发光免疫试验(cIA)和ELISA三种方法与国际标准(NIBSC 编号:00/588)同时检测,将结果进行比对。结果该标准物质定值为:(34.2±4.8)IU/ml。其稳定性实验表明室温(20～25℃,相对湿度20%～50%)可稳定4周;高温高湿度(37℃,相对湿度60%～80%)条件下,可稳定2周;在冰箱冷藏(2～8℃)保存,可稳定1年;-20℃可稳定1年以上。均一性检测结果:所采用的检测方法表明均匀性良好,无明显差异。结论该制备物可以作为 HBsAg 免疫测定的血清标准物质。Objective To establish an international reference materials for hepatitis B surface antigen （HBsAg） immunoassay in China. Methods The candidate sample were HBsAg positive and diluted in HBV-negative human plasma. The sample were then lyophilised with a concentration of approximately 40 IU/ml. ECLA, CIA and ELISA were used for quantification with international standard（ NIBSC cede：96/ 790） from NIBSC as calibrator. Results The titer of this lyophilised preparation is （33.42 ±2.66） IU/ml after calibration with the International Standard for HBsAg 00/588. The stability test indicate that the sample were stable at room temperature（20 - 25℃ ） for 4 weeks and at 37℃ for at least 2 week. Long-term stability was observed at 2 - 8℃ for 1 year and at - 20℃ for more than 1 year. There is no significant difference between vial-to-vial. Conclusion The lyophilized sample is established as the first national standard for immunoassay for HBsAg in China.

关 键 词：肝炎表面抗原 乙型 参考标准 

分 类 号：R446.6[医药卫生—诊断学]