背景:不同研究报告的活化部分凝血活酶时间(APTT)临界值存在显着差异,其中大多数没有对任何特定的明确检测系统提出建议。国际血液学标准化理事会(ICSH)建议根据试剂类型确定APTT临界值,凝血因子敏感性和肝素反应。这项研究的目的是通过使用不同的试剂并基于单个凝血因子缺陷来建立APTT临界值。
方法:在浓度为1IU/dL的商业内源性凝血因子缺乏血浆中测定APTT值,2IU/dL,5IU/dL,10IU/dL,20IU/dL,和30IU/dL通过使用四个测定系统。回顾性收集缺乏因子VIII(FVIII)的患者的数据,FIX,或单独进行FXI。构建受试者工作特征(ROC)曲线以评估APTT用于鉴定内源性凝血因子活性<5IU/dL的患者的诊断准确性。
结果:具有相同浓度的内源性凝血因子的血浆样品中的APTT值在四个测定系统之间显着不同(P<0.001)。SysmexCS5100(肌动蛋白FSL)的APTT建议临界值为40.0s,58.0s用于SysmexCS5100(肌动蛋白),51.8s用于STA-R演进(STA-PTTA),ACLTOP700(HemosILSynthasIL)为64.8s。在ROC曲线的基础上,APTT(STA-PTTA)的最佳阈值在单纯FVIII缺乏患者中为55.8s(敏感性=100%,特异性=85.7%,ROC曲线下面积(AUC)=0.982),单纯FIX缺乏患者的54.3s(敏感性=100%,特异性=92.9%,AUC=0.986),单纯FXI缺乏症患者为71.7s(敏感性=100%,特异性=94.1%,AUC=0.992),在等因子水平下更接近商业血浆的截止点(差异为0.6-2.5s)。
结论:需要根据单个凝血因子缺乏的存在,为不同的试剂建立APTT临界值。
BACKGROUND: There are significant differences in the activated partial thromboplastin time (APTT) critical values reported in different studies, most of which does not make recommendations for any specific clear detection systems. The International Council for Standardization in Hematology (ICSH) recommends that APTT critical values be established based on the reagent type, coagulation factor sensitivity and heparin response. The objective of this study was to establish APTT critical values by using different reagents and based on single coagulation factor deficiencies.
METHODS: The APTT values were determined in commercial endogenous coagulation factor-deficient plasma at concentrations of 1 IU/dL, 2 IU/dL, 5 IU/dL, 10 IU/dL, 20 IU/dL, and 30 IU/dL by using four assay systems. The retrospective collection of data from patients who lacked factor VIII (FVIII), FIX, or FXI alone was performed. Receiver operating characteristic (ROC) curves were constructed to assess the diagnostic accuracy of APTT for identifying patients with an endogenous coagulation factor activity < 5 IU/dL.
RESULTS: The APTT values in the plasma samples with the same concentrations of endogenous coagulation factors were significantly different among the four assay systems (P < 0.001). The suggested critical values of APTT were 40.0 s for Sysmex CS5100 (Actin FSL), 58.0 s for Sysmex CS5100 (Actin), 51.8 s for STA-R Evolution (STA-PTTA), and 64.8 s for ACL TOP 700 (HemosIL SynthasIL). On the basis of the ROC curve, the optimal threshold values for APTT (STA-PTTA) were 55.8 s in patients with a simple deficiency of FVIII (sensitivity = 100%, specificity = 85.7%, area under the ROC curve (AUC) = 0.982), 54.3 s in patients with a simple deficiency of FIX (sensitivity = 100%, specificity = 92.9%, AUC = 0.986), and 71.7 s in patients with a simple deficiency of FXI (sensitivity = 100%, specificity = 94.1%, AUC = 0.992), which were closer (difference of 0.6-2.5 s) to the cutoff points for commercial plasma at equal factor levels.
CONCLUSIONS: APTT critical values need to be established for different reagents based on the presence of a single coagulation factor deficiency.