VITROS XT 3400生化分析系统测定8种新型复合干片项目的性能验证

Performance evaluation of 8 kinds of new dry multi-sides in VITROS XT 3400 chemistry system

目的评价清蛋白(Alb)、总蛋白(TP)、天门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、肌酐(Cr)、尿素(Urea)、总胆固醇(TC)和三酰甘油(TG)8种复合干片项目在VITROS XT 3400生化分析系统中的性能。方法参照CLSI EP15-A3文件验证8种复合干片项目的正确度;参照WS/T492—2016文件验证项目的精密度;参照CLSI EP06-Ed2文件验证项目的线性范围;参照CLSI C28-A3c文件验证项目的参考区间;参照CLSI EP7-A2文件验证项目的抗干扰能力;参照CNAS-GL047文件进行方法学比对。结果8种复合干片项目的正确度验证结果显示,检测结果的均值均在确认区间(VI)内或检测偏差≤1/2允许总误差(TEa),符合EP15-A3文件要求。8种复合干片项目2个水平的精密度测定样品实验室内变异系数均≤1.66%,符合<1/3TEa的要求。所有项目检测结果的线性偏差90%置信区间(CI)均与1/2TEa相交,符合EP06-Ed2文件要求。参考区间验证显示90%以上的表观健康人群检测值落在厂商预设的参考区间之内,符合C28-A3c文件要求。抗干扰试验中,血红蛋白浓度分别达到286.76 mg/dL和207.84 mg/dL时,Alb和TP的检测偏差超过10%,与厂商声明相近。方法学比对显示VITROS XT 3400与VITROS 4600的仪器间符合率≥90%,符合CNAS-GL047文件要求。结论8种复合干片项目的正确度、精密度、线性范围、参考区间、抗干扰能力和方法学比对均符合质量管理的要求,能保证检验质量,满足临床应用需求。

Objective To evaluate the performance of Dry Multi-Sides(XT Micro-Slides)on VITROS XT 3400 chemistry system in clinical application for the assay of 8 kinds of serum proteins,i.e.,Alb(albumin),TP(total protein),AST(aspartate amino transferase),ALT(alanine aminotransferase),Cr(creatinine),Urea,TC(cholesterol)and TG(triglyceride).Methods The trueness of 8 kinds of Dry Multi-Sides was verified according to CLSI EP15-A3 document.The precision was verified referring to WS/T492—2016 document.The linear range was verified with the reference of CLSI EPO6-Ed2 document.The reference interval was verified referring to CLSI C28-A3c document.The anti-interference ability was verified referring to CLSI EP7-A2 document.The methodological comparison was conducted referring to CNAS-GLO47 document.Results The trueness evaluation for the 8 kinds of Dry Multi-Sides showed that the average values of the results were within the validation interval(VI)or less than or equal to 1/2 of the allowable total error(TEa),which was in line with the requirement of CLSI EP15-A3 document.The intra-laboratory coefficients of variation in the assay of the 8 kinds of Dry Multi-Sides for the samples with two levels of precision were all less than or equal to 1.66%,meeting the requirement of less than 1/3 TEa.The 90%confidence interval(CI)of the linear deviation of all test results intersected with 1/2 TEa,which meeted the requirements of the EPO6-Ed2 document.The verification of reference interval verification showed that the detected values of more than 90%of healthy individuals were fallen within the reference interval,which was in line with CLSI C28-A3c standard.In the anti-interference test,when the hemoglobin concentration reached 286.76 mg/dL and 207.84 mg/dL respectively,both the detection deviations of Alb and TP exceeded 10%,which was close to the manufacturer's statement.The results of methodological comparison showed that the accordance rate between VITROS XT 3400 and VITROS 4600 was greater than or equal to 90%,which were in line with the requirements of CNAS-GLO47 standard.Conclusion The trueness,precision,linear range,reference interval,anti-interference ability and methodological comparison of the 8 kinds of Dry Multi-Sides in laboratory-assays all met the requirements of quality control,thus they could ensure the quality requirements in clinical application.