一种国产血栓弹力图仪的性能评价

Performance evaluation of a domestic-made thrombelastography

目的评价T-400型血栓弹力图仪检测性能。方法抽取141名住院患者及20名健康体检者血样2.7m L/人(份),使用各自仪器的配套试剂,以反应时间(R)、K-时间(K)、角度(Angle)、最大振幅(MA)为主要分析参数,分别在T-400型血栓弹力图仪与TEG5000血栓弹力图仪上检测,以评价前者的准确度、批内精密度、日间精密度、血红蛋白干扰等,验证其参考区间和临床符合性。结果T-400与TEG5000检测到的R、K、Angle和MA值相近(P>0.05);R、K、Angle、MA各参数批内精密度与日间精密度变异系数(r)<15%;当游离血红蛋白<6 g/L时对各参数测定结果造成干扰的相对偏差(B)绝对值最大为16.37%(7.4/75.2),符合T-400生产厂家所声明的相对偏差<±20%;参考范围验证所得R值(R=结果落在检测值参考范围内的标本数/总检测标本数)93.0%(28/30);临床符合率≥93.33%(28/30)。结论T-400型血栓弹力图仪主要评估指标均符合仪器厂家所声明的性能,能够满足临床实验室的工作需要。

Objective To evaluate the performance of thrombelastography T-400.Methods The main evaluation indicators as reaction time(R),K time(K),Angle(A),and maximum amplitude(MA)were detected on thrombelastography T-400 and TEG5000,respectively,to evaluate the accuracy,inter-batch precision,and inter-day precision of them using the reagents provided by corresponding manufacturers.The interference test of free hemoglobin was carried out,simultaneously.Reference interval and clinical accord were also verified.Results The measured results of R,K,A,and MA showed no significant difference between thromboelastographies T-400 and TEG5000(P>0.05).Inter-batch and inter-day precision variation coefficient of R,K,Angle,MA were<15%.When the free hemoglobin was<6 g/L,the absolute value of relative deviation(B)that interfereed with the parameters results was 16.37%(7.4/75.2)at most,complying with T-400 manufacturer’s declaration of<±20%.90%—100%R values were within the reference range declared by the manufacturer.The clinical coincidence rate was≥93.33%(28/30).Conclusion The main evaluation indicators of thrombelastography T-400 are consistent with the performance claimed by the instrument manufacturer and can meet the needs of the clinical laboratory.