Mindray BS-400全自动生化分析仪在血站质控实验室的应用效果分析

Application Effect Analysis of Mindray BS-400 Automatic Biochemical Analyzer in Quality Control Laboratory of Blood Center

目的:检测Mindray BS-400全自动生化分析仪的主要性能,及在血站质控实验室总蛋白项目检测的应用效果分析。方法:检测Mindray BS-400全自动生化分析仪总蛋白(TP)、甘油三酯(TG)、谷丙转氨酶(ALT)、尿素(UREA)批内精密度、日间精密度、准确度、线性范围。利用室内质控累积变异系数和2020室间质评结果回报的偏倚,采用《临床生物化学检验常规项目分析质量指标》(WS/T403-2012)的允许总误差,计算TP项目的σ值。结果:批内精密度CV%:TP为0.42、TG为0.46、ALT为1.14、UREA为0.54。日间精密度CV%:TP为0.37、TG为0.30、ALT为1.42、UREA为0.62。准确度:TP为0.03、TG为0.00、ALT为0.03、UREA为0.01。线性验证相关系数r^(2):TP为0.9989、TG为0.9958、ALT为0.9998、UREA为1.000。TPσ值>6。结论:Mindray BS-400全自动生化分析仪批内精密度、日间精密度、准确度、线性范围均符合要求,且TPσ值>6,证明本室总蛋白项目检测系统达到了世界一流6σ水平。

Objective:To test the main performance of Mindray BS-400 automatic biochemical analyzer,and analyze the application effect of total protein detection in blood center quality control laboratory.Methods:The Mindray BS-400 automatic biochemical analyzer was tested for total protein(TP),triglycerides(TG),alanine aminotransferase(ALT),urea(UREA)intra-run precision,day-to-day precision,accuracy,linear range.Using the cumulative coefficient of variation of indoor quality control and the bias of the return of the 2020 inter-room quality assessment results,the allowable total error of the Analytical quality specifications for routine analytes in clinical biochemistry(WS/T403-2012)is used to calculate theσvalue of the TP item.Results:The intra-assay precision CV%:TP was 0.42,TG was 0.46,ALT was 1.14,and UREA was 0.54.The daytime precision CV%:TP is 0.37,TG is 0.30,ALT is 1.42,and UREA is 0.62.Accuracy:TP is 0.03,TG is 0.00,ALT is 0.03,and UREA is 0.01.Linear verification correlation coefficient r^(2):TP is 0.9989,TG is 0.9958,ALT is 0.9998,and UREA is 1.000.TPσvalue>6.Conclusion:The intra-run precision,day-to-day precision,accuracy and linear range of Mindray BS-400 automatic biochemical analyzer meet the requirements,and the TPσvalue is>6,which proves that our laboratory’s total protein project detection system has reached the world-class 6σlevel.