免疫分析仪检测血栓四项的性能验证

Performance verification of immune analyzer for detecting four items of thrombosis

目的通过对国产全自动化学发光免疫分析仪检测血栓四项进行性能验证,为该仪器是否适用于血栓四项的检测进行验证。方法参照临床实验室标准化研究所(CLSI)的指南文件及厂家试剂说明书要求,对上述仪器检测血栓调节蛋白(TM)、凝血酶-抗凝血酶复合物(TAT)、纤溶酶-抗纤溶酶复合物(PIC)、组织纤溶酶原激活物-抑制物1复合物(t PAIC)的精密度、线性特征、携带污染率、空白检出限及参考范围进行验证。结果万孚化学发光免疫分析仪用于检测TM、TAT、PIC、t PAIC项目的批内精密度结果变异系数(CV)均≤8%,批间精密度结果CV均≤10%,符合要求。线性验证结果可见各项目理论值与实测值回归方程,TM为Y=0.9886X-0.6988,r^(2)=0.9994;TAT为Y=0.9873X-0.4805,r^(2)=0.9995;t PAIC为Y=0.9914X+8.4791,r^(2)=0.9944;PIC为Y=0.9929X-0.8404,r^(2)=0.9906;验证结果均合格。携带污染率验证结果显示,高值对低值携带污染率及低值对高值携带污染率结果CV均<10%,符合要求。各项目的空白检出限结果可见,TM为0.01708 TU/m L,要求≤1.0 TU/m L。TAT为0.01988μg/L,要求≤0.4μg/L。t PAIC为0.00134μg/L,要求≤1.0μg/L;PIC为0.00065 mg/L,要求≤0.05 mg/L;验证结果均合格。参考范围验证结果可见,四个项目r值均≥0.95,验证合格。结论万孚全自动化学发光免疫分析仪符合检测血栓四项的性能验证要求。

Objective Through the performance verification of the domestic automatic chemiluminescence immunoassay analyzer to detect four items of thrombosis,and to verify whether the instrument could provide the detection of four items of thrombosis.Methods Refer to the guidelines of the Clinical and Laboratory Standards Institute(CLSI)and the requirements of the manufacturer's reagent specifications,the precision,linearity,carryover rate,blank detection limit and reference range of instrument for detecting thrombomodulin(TM),thrombin-antithrombin complex(TAT),plasmin antiplasmin complex(PIC)and tissue plasmin activator inhibitor 1 complex(tPAIC)were verified.Results The coefficient of variation(CV)of intra batch precision results for TM,TAT,PIC and tPAIC detected by the analyzer was≤8%,while the CV of inter batch precision results was≤10%,which met the requirements.The linear verification results showed that theoretical value and measured value of each item regression equations were as follows.TM was Y=0.9886X-0.6988,r^(2)=0.9994,TAT was Y=0.9873X-0.4805,r^(2)=0.9995,tPAIC was Y=0.9914X+8.4791,r^(2)=0.9944,PIC was Y=0.9929X-0.8404,r^(2)=0.9906,and the verification results were all qualified.The CV of the high value to low value carrying pollution rate and low value to high value carrying pollution rate were<10%,which met the requirements.Blank detection limit results for each item were as follows.TM was 0.01708 TU/mL and required≤1.0 TU/mL.TAT was 0.01988μg/L and required≤0.4μg/L.tPAIC was 0.00134μg/L and required≤1.0μg/L.The PIC was 0.00065 mg/L and required≤0.05 mg/L,and the verification results passed.The verification results of the reference range could be seen that the r values of the four items were≥0.95,and the verification was passed.Conclusions Wanfu automatic chemiluminescence immunoassay analyzer meets the performance verification requirements for detecting four items of thrombosis.