Olympus AU400型全自动生化分析仪性能验证

目的 为参加医学实验室认可和了解仪器性能,需评估一台寿命长达12年的Olympus AU400型全自动生化分析仪.方法 通过评估天门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、γ-谷氨酰转移酶、碱性磷酸酶、总蛋白、清蛋白、糖、尿素氮、肌酐、尿酸、乳酸脱氢酶、羟丁酸脱氢酶(α-HBDH)等12个项目的 精密度、线性范围、灵敏度、正确度等,评估仪器的性能.结果 AU400型全自动生化分析仪,在精密度、线性范围以及正确度方面,均可达到ISO15189认可所要求的仪器性能指标或者仪器声明的指标等.而AST、ALT、ALP、ALB、α-HBDH等,检测限高于仪器声明检测限,可能与仪器老化有关.结论 尽管AU400型生化分析仪使用年限较高,但除仪器灵敏度受损外,性能依然良好,完全符合ISO15189分析质量要求.

Evaluation of the Olympus AU400 clinical chemistry analyzer

Objective To evaluate an Olympus AU400 clinical chemistry analyzer for the recognition of medical laboratory and the understanding of instrument function.Methods AST,ALT,GGT,ALP,TP,ALB,GLU,UREA,CREA,URCA,LDH and α-HBDH assays were tested.Precision,linear range,sensitivity,accuracy were measured.Results Although AU400 was aged,the performance of precision,linear range and accuracy could meet for the needs of ISO15189 or claims of company.But AST,ALT,ALP,ALB and α-HBDH were beyond the value exclaimed by Olympus,it might induced that the analyzer was aged.Conclusion Although the AU400 chemistry analyzer was aged,the performance was also satisfactory for the need of ISO15189 except the sensitivity.