Clinical significance of the mixing test in laboratory diagnoses of lupus anticoagulant: the fate of the mixing test in integrated lupus anticoagulant test systems

Clinical significance of the mixing test in laboratory diagnoses of lupus anticoagulant: the fate of the mixing test in integrated lupus anticoagulant test systems
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DOI:
10.1097/mbc.0b013e328358e899
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发表时间:
2012-12-01
影响因子:
1.1
通讯作者:
Kim, Hyun Kyung
Kim, Hyun Kyung
中科院分区:
医学4区
文献类型:
--
作者:
Hong, Sung Kuk;Hwang, Sang Mee;Kim, Hyun Kyung

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混合试验用于在狼疮抗凝剂的实验室诊断中确定抑制物的存在。最新的国际指南指出,狼疮抗凝剂综合测试系统不需要混合测试;因此,需要对狼疮抗凝剂综合测试系统的混合测试进行评估。我们通过血栓风险分析,使用混合试验的最佳截断值来研究混合试验的临床相关性。对525例筛查阳性的狼疮患者采用罗氏蛇毒(DRVVT)和硅胶凝血时间两种综合抗凝试验进行回顾性分析。评估了两种解释公式(校正百分比、Rosner指数)的诊断性能,并基于混合结果研究了亚组的血栓形成风险。最后,根据狼疮抗凝综合检测系统程序对狼疮抗凝药物阳性的血栓形成风险进行评估,以评估狼疮抗凝综合检测系统中混合试验排除的可能性。基于dRVVT的混合测试解释方法的最佳分界值为:校正百分比为60.1%,Rosner指数为15.7。在矫正百分比和Rosner指数之间,血栓形成的风险没有实质性差异。混合阳性组的狼疮抗凝血滴度和血栓形成风险均高于混合阴性组。然而,即使是混合阴性组也有显著的血栓形成风险。最后,通过最新的两步程序(筛选和确认测试)确定的狼疮抗凝剂阳性显示出比传统的三步程序(筛选、混合和确认测试)确定的更高的血栓形成风险。虽然阳性混合结果可以预测血栓形成的高风险,但阴性混合结果也与实质性的血栓形成风险相关。在血栓风险评估的背景下,最新的两步程序不需要混合试验对于狼疮抗凝剂的检测是相关的。血液凝结纤溶23:739-744(C)2012 Wolters Kluwer Health垂直条Lippincott Williams&Wilkins。
The mixing test is used to determine the presence of inhibitors in laboratory diagnoses of lupus anticoagulant. Updated international guidelines state that an integrated lupus anticoagulant test system does not require the mixing test; an appraisal of the mixing tests in integrated lupus anticoagulant test systems is, therefore, required. We investigated the clinical relevance of mixing tests by using the best cutoff value of the mixing test through thrombotic risk analysis. A retrospective analysis was performed on 525 specimens with positive screening tests by using two integrated lupus anticoagulant tests: diluted Russell's Viper venom (dRVVT) and silica clotting time. The diagnostic performance of two interpretation formulas (percentage correction, Rosner index) was assessed, and the thrombotic risk of a subgroup based on the mixing results was investigated. Finally, the thrombotic risk of lupus anticoagulant positivity based on the integrated lupus anticoagulant test system procedures was assessed for the appraisal of mixing test exclusion in integrated lupus anticoagulant test systems. The best cutoff values of mixing test interpretation methods based on dRVVT were as follows: 60.1% for percentage correction and 15.7 for Rosner index. There was no substantial difference in the thrombotic risk between percentage correction and the Rosner index. The mixing-positive group showed a higher lupus anticoagulant titer and higher thrombotic risk than the mixing-negative group. However, even the mixing-negative group carried a significant risk of thrombosis. Finally, lupus anticoagulant positivity determined by the updated two-step procedure (screening and confirmation tests) showed higher thrombotic risk than that determined by the traditional three-step procedure (screening, mixing, and confirmation tests). Although a positive mixing result can predict a high risk of thrombosis, negative mixing results are also associated with a substantial thrombotic risk. The updated two-step procedure without the mixing test is relevant for lupus anticoagulant detection in the context of thrombotic risk estimation. Blood Coagul Fibrinolysis 23: 739-744 (C) 2012 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.