Laboratoire d'Hématologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
Immunologie Clinique, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
Int J Lab Hematol. 2024 Dec;46(6):1109-1117. doi: 10.1111/ijlh.14349. Epub 2024 Aug 5.
It is recommended to use two chronometric assays of different principles for the diagnosis of lupus anticoagulant (LA), consisting in diluted Russell Viper Venom Time (dRVVT) and activated Partial Thromboplastin Time (aPTT). Yet, there are only a few integrated aPTT assays; this study aims to evaluate one of them: Cephen LS/Cephen (Hyphen Biomed).
249 samples of patients were included in this study. Normal reference ranges were determined with platelet-poor plasma (PPP) from healthy blood donors. Performances were then evaluated by comparing Cephen LS/Cephen test results to the results of the laboratory's reference assay for the diagnosis of LA and to clinical data, both on non-anticoagulated and anticoagulated patients' samples (Unfractioned heparin (UFH), Low Molecular Weight Heparin (LMWH), Vitamin K Antagonists (VKA) and apixaban). Interference of UFH, LMWH and VKA were also evaluated thanks to spiking experiment of increasing heparin concentrations or factor deficiency.
Cephen LS/Cephen test had 48.6% sensitivity towards LA. Although UFH and VKA seemed to interfere with this assay and were likely to cause false negative, LMWH and apixaban did not. Finally, combination of Cephen LS/ Cephen with dRVVT had 89.0% sensitivity.
Cephen LS/Cephen seems relevant for LA diagnosis, in combination with dRVVT, and might be used in patients undergoing LMWH or apixaban therapy.
建议使用两种不同原理的计时检测法来诊断狼疮抗凝物（LA），即稀释 Russell 蝰蛇 venom 时间（dRVVT）和活化部分凝血活酶时间（aPTT）。然而，目前仅有少数整合型 aPTT 检测法；本研究旨在评估其中一种，即 Cephen LS/Cephen（Hyphen Biomed）。
本研究纳入了 249 例患者的样本。正常参考范围是用血小板缺乏的血浆（PPP）从健康献血者中确定的。然后通过比较 Cephen LS/Cephen 检测结果与实验室 LA 诊断的参考检测结果以及非抗凝和抗凝患者样本的临床数据（未分级肝素（UFH）、低分子肝素（LMWH）、维生素 K 拮抗剂（VKA）和阿哌沙班）来评估性能。还通过增加肝素浓度或因子缺乏的加标实验来评估 UFH、LMWH 和 VKA 的干扰。
Cephen LS/Cephen 检测对 LA 的敏感性为 48.6%。虽然 UFH 和 VKA 似乎干扰了该检测法，可能导致假阴性，但 LMWH 和阿哌沙班没有。最后，Cephen LS/Cephen 与 dRVVT 联合使用的敏感性为 89.0%。
Cephen LS/Cephen 似乎与 dRVVT 联合用于 LA 诊断具有相关性，可用于正在接受 LMWH 或阿哌沙班治疗的患者。
