Department of Laboratory Medicine, Tenri Hospital, Tenri, Japan.
Protein technology, Department of Reagent engineering, Sysmex Corporation, Kobe, Japan.
Int J Lab Hematol. 2024 Dec;46(6):1084-1091. doi: 10.1111/ijlh.14289. Epub 2024 Apr 21.
Mixing tests in activated partial thromboplastin time (APTT) are used for the differentiation between lupus anticoagulants (LA), coagulation inhibitors, and factor deficient samples with APTT prolongation. However, the indexes for the differentiation have not been established. The present study aimed to develop new mixing test indexes for the differentiation.
Twenty-six LA-positive, 8 progressive coagulation factor VIII inhibitor, and 35 coagulation deficient samples were employed. APTT were measured for normal plasma, patient plasma, and mixing plasma prepared at a ratio of 1:1 proportion in both without incubation and 2 h-incubation. New two parameters named as ALD50 and mixture plasma-patient plasma after Warming change rate Subtraction (WaS) calculated from the clotting times of normal, 1:1 mixing and patient samples with/without 2 h-incubation were established. In the samples with WaS result of <10.2%, ALD50 of ≥87.8%, and < 87.8% were defined as LA and coagulation factor deficiency, respectively, and WaS of ≥10.2% defined progressive coagulation factor inhibitors.
Sensitivity and specificity to LA were 80.8% and 93.0% for ALD50, and sensitivity and specificity to progressive coagulation factor inhibitor were 100.0% and 100.0% for WaS, respectively. The agreement between sample classification and WaS-ALD50 was 88.4% (61/69).
ALD50 and WaS showed acceptable sensitivity and specificity to LA and progressive coagulation factor inhibitor, respectively. These indexes would be useful for the differentiation between LA, factor deficiency, and progressive coagulation factor inhibitor in the mixing tests.
在活化部分凝血活酶时间(APTT)中进行混合试验,用于区分狼疮抗凝物(LA)、凝血抑制剂和 APTT 延长的因子缺乏样本。然而,尚未建立用于区分的指标。本研究旨在开发新的混合试验指标用于区分。
使用 26 例 LA 阳性、8 例进行性凝血因子 VIII 抑制剂和 35 例凝血因子缺乏样本。在无孵育和孵育 2 小时的情况下,以 1:1 的比例在正常血浆、患者血浆和混合血浆中测量 APTT。从正常、1:1 混合和患者样本的凝血时间计算出两个新参数,即 ALD50 和混合血浆-患者血浆在孵育 2 小时后的变化率减去 WaS(WaS)。在 WaS 结果<10.2%、ALD50≥87.8%和<87.8%的样本中,ALD50 定义为 LA 和凝血因子缺乏,WaS≥10.2%定义为进行性凝血因子抑制剂。
ALD50 对 LA 的敏感性和特异性分别为 80.8%和 93.0%,WaS 对进行性凝血因子抑制剂的敏感性和特异性分别为 100.0%和 100.0%。样本分类与 WaS-ALD50 的一致性为 88.4%(61/69)。
ALD50 和 WaS 对 LA 和进行性凝血因子抑制剂分别具有可接受的敏感性和特异性。这些指标对于在混合试验中区分 LA、因子缺乏和进行性凝血因子抑制剂将是有用的。