摘要
目的标定出凝血活酶参考品（ＷＲＰ），为国内凝血活酶产品国际敏感度指数（ＩＳＩ）的标定提供依据。方法以凝血活酶国际参考品为标准（ＩＲＰ），按照世界卫生组织（ＷＨＯ）推荐的凝血活酶国际参考品的使用方法进行测定，计算出被标定凝血活酶参考品的ＩＳＩ值和标定ＩＳＩ值的变异系数（ＣＶ）。结果标出的凝血活酶参考品的ＩＳＩ值为１．３５，标定ＩＳＩ值的ＣＶ为４．３％。符合ＷＨＯ的要求（ＣＶ≤５％）。结论用ＩＲＰ标定的凝血活酶参考品可作为国内凝血活酶试剂ＩＳＩ值标定的标准。
Objective To assay the International Sensitivity Index(ISI) for the Working Reference Preparation(WRP) of thromboplastins. Methods Using the International Reference Preparation(IRP) as the calibrator, according to the method recommended by World Health Organization(WHO) for using the WHO IRP, to do the calibration for the WRP of thromboplastin against the IRP, calculated the ISI value for the WRP and the coefficient of variation ( CV ) for the ISI. Results The ISI value of the WRP was 1.35, the CV for the ISI was 4.3%, was not up to the standard(less than 5%) recommended by WHO. Conclusion The WRP could be used as the calibrator for assay the ISI value for thromboplastin reagent.
