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作 者:于悦 YU Yue(Dalian Central Hospital,Liaoning Dalian 116000)
出 处:《中国医疗器械信息》2021年第20期26-27,共2页China Medical Device Information
摘 要:目的:探讨两种使用不同检测原理的全自动血凝分析仪在凝血五项的检查中,对检测结果进行了对比分析,探讨两种全自动血凝分析仪检测结果的一致性。方法:选择本院从2018年3月~2020年3月进行检测的260例凝血五项检测结果数据作为本次研究对象。在不连续的5d之内,进行血液样本的采集工作,收集患者新鲜血浆标本260份,每份标本在两种全自动血凝分析仪上,分别进行了APTT、RT、FIB和TT的检测。结果经线性回归后,将系数记为r值,将总允许误差记为1/2TEa。观察两种全自动血凝分析仪测定结果的可比性。结果:通过对两种全自动血凝分析仪在凝血五项的检测结果进行对比,可知两台仪器的关联性较差,各项目在各医学决定水平上的相对偏差,超过了1/2总允许误差(1/2TEa)。结论:两种全自动血凝分析仪,在凝血五项的检测结果上,一致性较差。在临床使用过程中,同时应用这两种设备,不符合实验管理的要求。因此不建议在临床同时使用上述的两种全自动血凝分析仪。Objective:To investigate the comparison and analysis of the test results of two kinds of automatic blood coagulation analyzers using different detection principles in the five tests of coagulation,and to discuss the consistency of the test results of the two automatic blood coagulation analyzers.Methods:The five test results of 260 cases of blood coagulation tested in our hospital from March 2018 to March 2020 were selected as the object of this study.Within 5 discontinuous days,blood samples were collected,and 260 fresh plasma samples were collected from patients.Each sample was tested for APTT,RT,FIB,and TT on two automatic blood coagulation analyzers.After the result is linear regression,the coefficient is recorded as the r value,and the total allowable error is recorded as 1/2TEa.Observe the comparability of the results of the two automatic blood coagulation analyzers.Results:By comparing the test results of five coagulation items of the two automatic coagulation analyzers,it can be seen that the two instruments have poor correlation,and the relative deviation of each item in each medical decision level is more than 1/2 total allowable error(1/2 TEa).Conclusion:The two automatic blood coagulation analyzers have poor consistency in the detection results of the five coagulation items.In the process of clinical use,the simultaneous application of these two devices does not meet the requirements of experimental management.Therefore,it is not recommended to use the above two automatic blood coagulation analyzers at the same time in clinical practice.
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