4种活化部分凝血活酶时间试剂因子敏感性的量化评估及临床应用探讨

Intrinsic pathway factor responsiveness and clinical application of four APTT reagents

目的量化评估4种活化部分凝血活酶时间(APTT)试剂的FⅧ、FⅨ、FⅪ、FⅫ敏感性,分析其临床适用范围。方法采用美国临床和实验室标准化协会(CLSI)H47-A2的APTT试剂敏感性评估方法,检测由标准血浆和单因子缺乏血浆配制的<1%～100%不同因子水平混合血浆的APTT值。APTT试剂敏感性由非线性回归曲线与正常参考区间上限的交叉点确定,并用百分活度(%)表示。结果试剂A(上海太阳生物技术有限公司,鞣花酸)的因子敏感性为FⅧ54.0%,FⅨ37.3%,FⅪ56.5%,FⅫ36.4%;试剂B(上海太阳生物技术有限公司,白陶土)的因子敏感性为FⅧ25.6%,FⅨ16.5%,FⅪ23.8%,FⅫ18.6%;试剂C(西门子公司)的因子敏感性为FⅧ42.9%,FⅨ30.0%,FⅪ45.3%,FⅫ28.4%;试剂D(思塔高公司)的因子敏感性为FⅧ26.1%,FⅨ17.6%,FⅪ19.1%,FⅫ21.0%。结论 4种APTT试剂的内源性因子敏感性差异较大。试剂A适用于亚临床型血友病A、B的筛查;试剂C适用于术前筛查;试剂B和试剂D适用于内源性单因子缺乏的确证试验。

Objective To evaluate the responsiveness to single factor levels of four APTT reagents,and analyze the different scopes of clinical application.Methods We evaluated,according to the recommendation of the CLSI H47-A2 guideline,the responsiveness to single factor levels of four APTT reagents by using factor-deficient plasmas spiked with a calibration plasma to produce individual factor activities ranging from<1%to 100%.The APTT responsiveness in percent activity(%)could be determined from the intersection of the curve and the upper limit of the APTT normal reference range for that APTT reagent.Results APTT responsiveness of SUNBIO(ellagic acid)was as follows:FⅧ54.0%,FⅨ37.3%,FⅪ56.5%,FⅫ36.4%;APTT responsiveness of SUNBIO(kaolin)was as follows:FⅧ25.6%,FⅨ16.5%,FⅪ23.8%,FⅫ18.6%;APTT responsiveness of Siemens Dade Actin was as follows:FⅧ42.9%,FⅨ30.0%,FⅪ45.3%,FⅫ28.4%;APTT responsiveness of STAO-PTTA was as follows:FⅧ26.1%,FⅨ17.6%,FⅪ19.1%,FⅫ21.0%.Conclusion The responsiveness of the tested APTT reagents to single factor deficiency is highly variable.SUNBIO(ellagic acid)is suitable for assisting diagnosis of subclinical hemophilia A and B;Siemens Dade Actin is suitable for preoperative screening;SUNBIO(kaolin)and STAO-PTTA is suitable for identifying single intrinsic pathway factor deficiencies.