强生Vitros V5600全自动生化分析仪性能评价及在急诊检验中的应用

Performance Evaluation of Johnson Vitros V5600 Full-automatic Biochemistry Analyzer and Application in the Emergency Test

目的对强生Vitros V5600全自动生化分析仪进行性能验证,以便为急诊检验提供迅速、准确的检测结果。方法参照美国临床实验室标准化委员(NCCLS)指南有关检测系统性能验证文件EP15A、EP6-A的要求对选定生化检测项目的精密度、线性范围、最大稀释倍数、方法学比对进行评价。结果 21项生化指标的精密度、线性范围均符合厂商说明;经稀释后检测均值回收率均在90%<R<110%之间。结论强生Vitros V5600全自动生化分析仪的分析性能符合质量目标要求。

Objective To validate the Johnson Vitros V5600 full-automatic biochemistry analyzer in order to provide rapid and accurate detection results of emergency test. Methods The precision, linearity range, maximum valid dilute double and methodology comparison of selected biochemical test items were evaluated referring to the requirement of test system perfor-mance verification file EP15A and EP6-A in the American committee of clinical laboratory standards guidance. Results The precision degree and linearity range of 21 biochemical indicators conforming to the manufacturer instructions were e-valuated, and the recovery rate of detection mean value was between 90% and 110% after dilution. Conclusion The analyt-icity of Johnson Vitros V5600 full-automatic biochemistry analyzer can meet the quality target requirement.