Belsey R E, Fischer P M, Baer D M
Department of Clinical Pathology, Oregon Health Sciences University, Portland 97201.
J Fam Pract. 1991 Sep;33(3):266-71.
The prothrombin time (PT) test, which is the most common coagulation test used in the outpatient setting, has not been recommended for office laboratory use because it has been technically difficult to perform. Consequently, serious errors in patient care could occur because of an erroneous result. The Coumatrak (E.I. Du Pont, Wilmington, Del) now allows nontechnically trained office staff to perform PT tests using a fresh capillary whole blood sample, individually packaged reagent cartridges, and a portable battery-operated instrument.
Coumatrak PT testing was compared with standard methods for both precision and accuracy, using protocols developed by the National Committee for Clinical Laboratory Standards (NCCLS). Reagent stability and operator variability were also studied.
The results produced by a trained technologist and nontechnically trained staff were comparable. Test results obtained with the Coumatrak were approximately 10% higher than results obtained using standard laboratory equipment and methods using comparable blood samples from the same patients. It was found that the capillary blood specimen had to be rapidly transferred to the reagent cartridge in order to avoid factitiously low results.
The Coumatrak can rapidly provide PT test results that are clinically useful for the office management of patients being treated with a warfarin anticoagulant and for the diagnosis of selected disorders. The system was found to be easy to operate, appropriate for use by individuals with little laboratory experience, and was subject to few operational problems during this study.
凝血酶原时间（PT）检测是门诊最常用的凝血检测项目，但由于技术操作困难，一直未被推荐用于门诊实验室。因此，错误的检测结果可能导致严重的医疗差错。现在，库马特拉克凝血分析仪（美国特拉华州威尔明顿市杜邦公司生产）使未经技术培训的门诊工作人员能够使用新鲜的毛细血管全血样本、单独包装的试剂卡以及便携式电池驱动仪器进行PT检测。
按照美国国家临床实验室标准委员会（NCCLS）制定的方案，将库马特拉克PT检测与标准方法在精密度和准确性方面进行比较。同时还研究了试剂稳定性和操作人员的差异。
经过培训的技术人员与未经技术培训的工作人员所得到的检测结果相当。使用库马特拉克凝血分析仪得到的检测结果比使用标准实验室设备和方法对同一患者采集的可比血样所得到的结果大约高10%。研究发现，为避免人为造成的低结果，毛细血管血标本必须迅速转移至试剂卡中。
库马特拉克凝血分析仪能够迅速提供PT检测结果，这些结果对于使用华法林抗凝治疗的患者的门诊管理以及某些疾病的诊断具有临床实用价值。研究发现该系统易于操作，适合几乎没有实验室经验的人员使用，并且在本研究期间很少出现操作问题。
