全自动凝血分析仪ACL-TOP检测系统的性能验证

Performance Verification of ACL-TOP Automatic Coagulation Analyzer Detection System

目的:对美国Beckman-Coulter公司ACL-TOP型全自动凝血分析仪检测系统的主要分析性能进行验证。方法:对该仪器检测项目凝血酶原时间(PT)、活化部分凝血酶原时间(APTT)、纤维蛋白原(FIB)、凝血酶时间(TT)及D-二聚体(D-D)进行性能验证。利用变异系数对精密度进行评价;利用携带污染率对携带污染情况进行评价;利用线性方程对检测项目的线性范围进行评价;利用相对偏差对仪器间的结果比对进行评价。结果:该仪器检测项目PT、APTT、FIB、TT及D-D的批内及批间精密度均小于6%,批内及批间变异均在可接受范围内;PT、APTT、FIB、TT及D-D的携带污染率分别为0.43%、1.56%、1.06%、1.43%及1.98%,符合仪器性能要求;线性验证标本按一定比例稀释后将所得理论值与实测值进行回归分析,b值均介于0.97～1.03范围内,r均大于0.975,符合线性要求;与参比仪器各检测项目的相对偏差均小于仪器厂家提供的1/2允许总误差(TE),符合仪器性能要求。结论:ACL-TOP检验系统的精密度、携带污染率、线性范围及仪器间比对结果等基本符合实验诊断学实验室的要求,可用于临床标本的检测。

Objective To verify the main performances of ACL-TOP automatic coagulation analyzer from Beckman-Coulter of America.Methods Prothrombin time（PT）,active partial thromboplastin time（APTT）,fibrinogen（FIB）,thrombin time（TT） and D-Dimer（D-D） were selected to verify the performance of the equipment.The precision was evaluated by coefficient variation（CV）,carry-over by carry-over rate,linear range by regression equation and the comparison of different machines by relative deviation.Results The precision of PT,APTT,FIB,TT and D-D were lower than 6%.All the precision of selected testing items were within an acceptable range.The carryover rates of PT,APTT,FIB,TT and D-D were 0.43%,1.56%,1.06%,1.43% and 1.98%,respectively.The linear verification results got the regression equation of the theoretical and measured values y=bx＋a,in which b was within the range of 0.97～1.03,and r0.975.The relative deviation in different machines was lower than 1/2 total errors（TE） provided by equipment factory.Conclusion The precision,carryover rates,the comparison results in different machines and linearity of the selected testing items of ACL-TOP automatic coagulation analyzer accord with the demands of the experiments in clinical diagnosis,which can be used clinically.