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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40IU／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.
Hepatitis B surface antigen; Reference standards HBV