Poller L, Thomson J M
J Clin Pathol. 1972 Dec;25(12):1038-44. doi: 10.1136/jcp.25.12.1038.
Nine partial thromboplastin (cephalin) reagents have been compared in a parallel investigation of groups of patients on ;long-term' anticoagulants, a group with moderate haemophilia, and patients on heparin infusion. Results with the seven commercial reagents and a human cephalin extract have been correlated with those of a specially prepared and standardized reference preparation of human brain origin. The comparison was similar in principle to that of the prothrombin time thromboplastin standardization using the British Comparative Thromboplastin (BCT). Results, which for comparative purposes were expressed as ratio of patients' cephalin times to control cephalin times, varied greatly in all three groups. In the oral anticoagulant group some of the commercial reagents were particularly insensitive to the ;intrinsic' clotting defect. The correlation between the ;standardized preparation' and the other reagents was not good and the use of a reference cephalin material for quality control of cephalin time tests does not appear promising. In moderate haemophilia the commercial reagents were either relatively poor at picking out the clotting defect compared with the ;standardized preparation' or gave such a bad endpoint that the results were not dependable. The poor endpoint also limited the dependability of the results of all but the ;standardized preparation' and two of the commercial reagents in controlling heparin administration. In view of these standardization difficulties, which cannot apparently be resolved by the use of reference material, there is need for bulk, routine supplies of a sensitive, standardized cephalin reagent giving good reproducible endpoints. The method for the provision of such material in a recently introduced national supply scheme is described.
在一项平行研究中,对九种部分凝血活酶(脑磷脂)试剂进行了比较,研究对象包括服用“长期”抗凝剂的患者组、中度血友病患者组以及接受肝素输注的患者。七种市售试剂和一种人脑磷脂提取物的检测结果与一种特别制备并标准化的人脑来源参考制剂的结果进行了关联。该比较原则上类似于使用英国比较凝血活酶(BCT)进行凝血酶原时间凝血活酶标准化的比较。为便于比较,结果以患者脑磷脂时间与对照脑磷脂时间的比值表示,在所有三组中差异都很大。在口服抗凝剂组中,一些市售试剂对“内源性”凝血缺陷特别不敏感。“标准化制剂”与其他试剂之间的相关性不佳,使用参考脑磷脂材料进行脑磷脂时间检测的质量控制似乎前景不佳。在中度血友病中,与“标准化制剂”相比,市售试剂在识别凝血缺陷方面相对较差,或者终点不佳,以至于结果不可靠。除了“标准化制剂”和两种市售试剂外,终点不佳也限制了在控制肝素给药时所有结果的可靠性。鉴于这些标准化困难,显然无法通过使用参考材料来解决,因此需要大量常规供应一种敏感、标准化的脑磷脂试剂,其终点具有良好的可重复性。本文描述了在最近引入的国家供应计划中提供此类材料的方法。