摘要
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.
作者
王威
何晓璇
仝晓宁
刘哲
邓凯
王刚
WANG Wei;HE Xiaoxuan;TONG Xiaoning;LIU Zhe;DENG Kai;WANG Gang(Department of Clinical Laboratory,the First Affiliated Hospital of Medical College of Xi′an Jiaotong University,Xi′an,Shaanxi 710061,China)
出处
《检验医学与临床》
CAS
2018年第8期1118-1120,1124,共4页
Laboratory Medicine and Clinic