摘要
目的:建立酶联免疫法检测乙型肝炎人免疫球蛋白抗-HBs效价的测定方法。方法:依据2015年版中国药典的规定,乙型肝炎人免疫球蛋白抗-HBs效价采用酶联免疫法测定,并应用生物检定统计法中的量反应平行线法设计实验,检测实验可靠性,计算效价。结果:每次实验的可靠性均符合2015年版中国药典规定,可信限率在10%以内,专属性强,试剂盒和仪器因素检测结果经F检验,差异无统计学意义(P>0.05),重复性RSD为1.61%。当抗-HBs效价在0.0512~0.1 IU·mL^(-1)范围内时,标准品和样品线性相关系数均大于0.99。7批样品与厂家放射免疫法的结果经F检验,无统计学差异(P>0.05)。结论:乙型肝炎人免疫球蛋白抗-HBs效价采用酶联免疫法测定,量反应平行线法分析,测定结果稳定、可靠,操作安全、快速、无污染,可用于乙型肝炎人免疫球蛋白抗-HBs效价检测。
Objective :To Establish the ELISA method to test the potency of anti –HBs on human hepatitis B immunoglobulin. Methods: According to the regulations of ChP. 2015,the ELISA was used for detecting the potency of anti –HBs on human hepatitis B immunoglobulin. Meanwhile, the quantity response parallel line analysis of bioassay-statistical was applied to design the experiment. The reliability was examined and the potency was calculated. Results: The reliable test of each experiment met the specification of ChP. 2015. The fiducial limit rate was within 10%. The specificity was good. The determination results by two different kits and instruments were analyzed by F test and showed no significant difference(P〉0.05). The relative standard substance deviation (RSD) in reproducibility test was 1.61 %. While the anti –HBs potency of standard and samples were between 0.0512 IU.mL-1~0.1 IU.mL-1, the linear correlation coefficients (r values) were both more than 0.99.The result of 7 batches of samples showed no statistical difference (P〉0.05) by F test with manufacturers radioimmunoassay. Conclusion: The testing results were stable and reliable. The operation was safe, rapid and without contamination. The anti –HBs potency on human hepatitis B immunoglobulin detected by the ELISA method and analyzed by the quantity response parallel line was validated.
出处
《中国药品标准》
CAS
2017年第6期439-442,共4页
Drug Standards of China