国产大型生化分析仪——迈瑞BS-800性能验证及临床应用评价

Performance verification and evaluation on clinical application of MINDRAY BS-800 automatic biochemical analyzer

目的:验证国产大型生化分析仪—迈瑞BS-800的检测性能,分析其临床应用能力。方法:对迈瑞BS-800生化分析仪的吸光度范围、不精密度、测量范围、携带污染等检测性能进行验证,并在模拟临床检测环境下,进行常规生化检测,分析其临床应用能力。结果:迈瑞BS-800生化分析仪吸光度范围最少可达到3.76A;以白蛋白检测实验为例,最小加样量不精密度为0.45%;不精密度实验、测量范围实验、比对实验的结果均小于厂家声明的性能指标;携带污染率小于厂家声明的相关项目的不精密度结果。结论:迈瑞BS-800生化分析仪检测性能可靠,运行稳定,操作简便,适用于临床生化检测的需求。

Objective：To verify the performance and evaluate the clinical application of MINDRAY BS-800 automatic biochemical analyzer.Methods：The performance verification was carried out by the absorbance linear range,the imprecision,the measurement range,the method comparison and the carry-over test.The evaluation on the clinical application was performed by running in the routine environment.Results：The absorbance linear range was at least 3.76A.The imprecision of the smallest sample-adding volume was 0.45%.The results of the imprecision,the measurement range,the method comparison and the carry-over test were less than those declared by the manufacturer.Conclusion：The MINDRAY BS-800 automatic biochemical analyzer has good performance,stable running and convenient operation.Therefore,it is suitable for clinical biochemistry assayed.