Gardiner C, Kohama K, Patel I, Lane P, Dwyer S, Machin S J, Mackie I J
University College London, London, UK.
Sysmex Corporation, Kobe, Japan.
Int J Lab Hematol. 2017 Oct;39(5):532-538. doi: 10.1111/ijlh.12691. Epub 2017 Jun 12.
A new prothrombin time reagent (Revohem™ PT) based on recombinant human tissue factor produced by the silkworm-baculovirus expression system was tested. The aim of this study was to compare the performance of the new PT reagent with two widely used routine PT reagents.
All testing was performed on a Sysmex CS-5100 coagulometer. Revohem PT was tested for imprecision and stability using normal and abnormal lyophilized commercial control plasmas. Comparability was assessed with two widely used reagents: one containing recombinant human tissue factor (Reagent A) and the other a human placental thromboplastin (Reagent B) using a wide range of normal and abnormal plasmas and analyser-specific ISI values.
Excellent between-day imprecision was obtained for Revohem PT (CV <1.0%) and acceptable open-vial on-board stability over 7 days. There was good agreement between methods in samples from patients with liver disease and patients receiving warfarin and no significant differences between methods with increasing INR values. Both recombinant reagents suffered less interference from lupus anticoagulant than the placental thromboplastin. Revohem PT had similar sensitivity to reagents A and B for FII, V, VII and X deficiency and demonstrated dose responsiveness to dabigatran, apixaban and rivaroxaban with steeper response curves than the comparison reagents.
Revohem PT showed comparable or improved performance relative to two widely used reagents and is suitable for use in warfarin control, detection of inherited factor II, V, VII and X deficiency and assessment of liver disease coagulopathy.
对一种基于家蚕杆状病毒表达系统生产的重组人组织因子的新型凝血酶原时间试剂（Revohem™ PT）进行了测试。本研究的目的是将这种新型凝血酶原时间试剂的性能与两种广泛使用的常规凝血酶原时间试剂进行比较。
所有检测均在Sysmex CS - 5100凝血分析仪上进行。使用正常和异常冻干商业对照血浆对Revohem PT进行不精密度和稳定性测试。使用两种广泛使用的试剂评估可比性：一种含有重组人组织因子（试剂A），另一种是人胎盘凝血活酶（试剂B），使用广泛的正常和异常血浆以及分析仪特定的国际敏感度指数（ISI）值。
Revohem PT获得了出色的日间不精密度（CV <1.0%），并且在7天内具有可接受的开封后机载稳定性。在肝病患者和接受华法林治疗的患者样本中，各方法之间具有良好的一致性，并且随着国际标准化比值（INR）值增加，各方法之间无显著差异。与胎盘凝血活酶相比，两种重组试剂受狼疮抗凝物的干扰较小。Revohem PT对因子II、V、VII和X缺乏症的敏感度与试剂A和B相似，并且对达比加群、阿哌沙班和利伐沙班表现出剂量反应性，其反应曲线比对照试剂更陡峭。
相对于两种广泛使用的试剂，Revohem PT表现出相当或更好的性能，适用于华法林监测、遗传性因子II、V、VII和X缺乏症的检测以及肝病凝血障碍的评估。
