Clin Chem Lab Med. 2016 Sep 1;54(9):1511-6. doi: 10.1515/cclm-2015-0978.
Lupus anticoagulant (LAC) testing includes a screening, mixing and confirmation step. Although recently published guidelines on LAC testing are a useful step towards standardization, a lack of consensus remains whether to express mixing tests in clotting time (CT) or index of circulating anticoagulant (ICA). The influence of anticoagulant therapy, e.g. vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) on both methods of interpretation remains to be investigated. The objective of this study was to contribute to a simplification and standardization of the LAC three-step interpretation on the level of the mixing test.
Samples from 148 consecutive patients with LAC request and prolonged screening step, and 77 samples from patients non-suspicious for LAC treated with VKA (n=37) or DOAC (n=30) were retrospectively evaluated. An activated partial thromboplastin time (aPTT) and dilute Russell's viper venom time (dRVVT) were used for routine LAC testing. The supplemental anticoagulant samples were tested with dRVVT only. We focused on the interpretation differences for mixing tests expressed as CT or ICA and compared the final LAC conclusion within each distinct group of concordant and discordant mixing test results.
Mixing test interpretation by CT resulted in 10 (dRVVT) and 16 (aPTT) more LAC positive patients compared to interpretation with ICA. Isolated prolonged dRVVT screen mix ICA results were exclusively observed in samples from VKA-treated patients without suspicion for LAC.
We recommend using CT in respect to the 99th percentile cut-off for interpretation of mixing steps in order to reach the highest sensitivity and specificity in LAC detection.
狼疮抗凝物(LAC)检测包括筛查、混合和确认步骤。尽管最近发布的 LAC 检测指南是标准化的一个有用步骤,但对于混合检测是用凝血时间(CT)还是循环抗凝剂指数(ICA)来表示,仍存在共识。抗凝治疗(如维生素 K 拮抗剂[VKA]或直接口服抗凝剂[DOAC])对这两种解释方法的影响仍有待研究。本研究的目的是为简化和标准化混合检测的 LAC 三步解释做出贡献。
回顾性评估了 148 例连续 LAC 请求且筛查步骤延长的患者样本,以及 77 例疑似 LAC 且接受 VKA(n=37)或 DOAC(n=30)治疗的患者样本。活化部分凝血活酶时间(aPTT)和稀释 Russell 蝰蛇 venom 时间(dRVVT)用于常规 LAC 检测。补充抗凝样本仅用 dRVVT 进行检测。我们专注于以 CT 或 ICA 表示的混合检测解释的差异,并比较了在具有一致和不一致混合检测结果的每个特定组内的最终 LAC 结论。
与 ICA 相比,CT 解释的混合检测结果导致 10(dRVVT)和 16(aPTT)例更多的 LAC 阳性患者。在没有怀疑存在 LAC 的 VKA 治疗患者的样本中,仅观察到孤立的延长 dRVVT 筛查混合 ICA 结果。
我们建议在解释混合步骤时使用 CT,以达到检测 LAC 的最高灵敏度和特异性,使用 99 百分位截断值。