目的 建立适用于人凝血因子Ⅷ效价测定(一期法)的统计分析方法。方法 采用一期法对人凝血因子Ⅷ的效价进行测定,采用量反应平行线测定法进行效价计算,并对该方法进行方法学验证。采用经验证的方法对来自7家企业的21批人凝血因子Ⅷ样品进行效价测定,并与标准曲线带入法进行比较。结果 效价测定范围为标示量的64%～156%;以效价测定值的对数对理论值的对数作线性回归,相关系数r为0.990 4;相对偏倚为0.5%～3.1%,其90%置信区间为-3.8%～6.1%;中间精密度为3.8%～6.7%,其95%置信上限为7.0%～12.3%;不同批次的激活的部分凝血活酶(APTT)试剂和人凝血因子Ⅷ缺乏血浆,对测定结果的影响无统计学意义,方法耐用性良好。采用量反应平行线测定法对21批样品进行测定,其结果与标准曲线带入法的结果表现出良好一致性。结论 与标准曲线带入法相比,应用量反应平行线测定法分析一期法测定的人凝血因子Ⅷ效价,可增加实验数据的可靠性,并有效控制测定方法的误差,从而更好地控制人凝血因子Ⅷ质量。

OBJECTIVE To establish a statistical analysis method for biological activity determination of human coagulation factor Ⅷ (one-stage assay). METHODS The biological activity of human coagulation factor Ⅷ was determined by one-stage assay, the RESULTS were calculated by parallel-line model, and then the method was verified. Finally, 21 batches of human coagulation factor Ⅷ from seven manufacturers were investigated using the method and the RESULTS were compared with those calculated by standard curve method. RESULTS The determination range was between 80% and 140% of the potency stated on the label, the correlation coefficients between measured and labelled values was 0.990 4. The relative bias ranged from 0.5% to 3.1%,with 90% confidence intervals from -3.8% to 6.1% .The intermediate precision was 3.8%-6.7%, with 95% upper confidence limit from 7.0%-12.3%. The effects of APTT and human coagulation factor Ⅷ deficiency plasma on the determination RESULTS were not statistically significant, and the method showed good robustness. The RESULTS of 21 batches measured by parallel-line model were in good agreement with those obtained by standard curve method. CONCLUSION Compared with the standard curve method, the analysis of the biological activity determined by one-stage assay with parallel-line model can increase the reliability of the data and effectively control the error of the determination method, so as to control the quality of human coagulation factor Ⅷ better.