不同型号血凝仪检测凝血酶原时间及部分凝血活酶时间的可比性评价

Comparative analysis of prothrombin time and activated partial thromboplastin time results in different blood coagulation analyzers by industry standards

目的探讨同一实验室内不同型号血凝仪检测凝血酶原时间(prothrombin time,PT)及部分凝血活酶时间(activated partial thromboplastin time,APTT)结果的可比性。方法用卫生行业标准《WS/T407-2012医疗机构内定量检验结果的可比性验证指南》及《WS/T406-2012临床血液学检验常规项目分析质量要求》提出的两种仪器间比对方案,对3台血凝仪(2台Sysmex CA7000和1台CA1500)所检测的PT及APTT进行比对,分析两种比对方案的可行性。结果用WS/T407-2012比对方案,样本1在3台仪器上检测PT和APTT的相对偏差分别为7.10%和5.20%,样本2的相对偏差分别为5.74%和2.46%,均<7.50%的比对要求。用WS/T406-2012比对方案,3台仪器分别检测20份标本,以相对偏差<7.50%、符合率≥80%为标准,CA1500与基准仪器CA7000比较,PT及APTT的符合率分别为85%(17/20份)、80%(16/20份),CA7000-2与基准仪器CA7000比较,PT及APTT的符合率分别为85%(17/20份)、90%(18/20份)。结论按照两种方案提出的比对方法,3个检测系统测定PT和APTT的结果具有可比性,实验室可根据实际情况选择合适的方案进行仪器间比对,以保证不同检测系统间检验结果的可比性。

Objective To analyze the comparative results of prothrombin time（PT） and activated partial thromboplastin time（APTT） in different SYSMEX coagulation analyzers. Methods PT and APTT were detected in three instruments（two of Sysmex CA7000 and one was CA1500）. The comparative analysis of test results by industry standards WS/T407-2012 and WS/T406-2012. Results Using the scheme WS/T407-2012, the relative deviations of PT and APTT of sample one were 7.10% and 5.20%, respectively; the relative deviations of sample two were 5.74% and 2.46%, respectively; both were less than the comparative request of 7.50%. Using the scheme WS/T406-2012, 20 samples were detected by the three instruments, the relative deviation 7.50% and the coincidence rate ≥ 80% set as the standard. Compared with the benchmark instrument CA7000, the coincidence rates of PT and APTT in CA1500 were 85%（17/20） and 80%（16/20）, respectively; those in CA7000-2 were 85%（17/20） and 90%（18/20）, respectively. Conclusions According to these two kinds of schemes comparative methods, the determination results of PT and APTT in three detection systems are comparable. The laboratory might choose appropriate solutions for instruments alignment according to the actual situation in order to ensure the result comparability.