佳能TBA-120RF全自动生化分析检测系统的精密度和准确度性能验证

Performance validation of precision and accuracy of Canon TBA-120FR automatic biochemical analyzer detection system

目的为提高实验室质量管理能力,提高检验结果的可靠性,对实验室佳能TBA-120FR全自动生化分析检测系统的精密度和准确度进行性能验证,并探讨其验证方法。方法通过参考美国临床和实验室标准协会(CLSI)EP15-A2文件及其他文献,使用CLSI EP15-A2文件中的统计学方法,运用WPS表格软件中的函数工具和SPSS软件中的统计学工具分别对该仪器的精密度和准确度进行性能验证。结果在该实验条件下,WPS表格软件中的函数工具计算出的实验室标准差(SDl)和实验室变异系数(CV)均在试剂厂家规定的范围内,由SPSS软件中的统计学工具计算出的相关方程均有良好相关性,线性方程分别为:天冬氨酸转氨酶(AST):y=0.941x-1.184,血糖(GLU):y=0.972x+0.050,血尿素氮(BUN):y=0.939x+0.051,血肌酐(SCr):y=1.015x-17.086,尿酸(UA):y=1.059x-8.197,三酰甘油(TG):y=1.030x+0.019(均R^(2)>0.99)。结论经验证TBA-120FR全自动生化分析检测系统具有较高的精密度和准确度,可以为临床提供可靠的检验参考结果,且验证过程简明易操作,验证结果可信程度高。

Objective To improve the ability of laboratory quality management and reliability of test results,the precision and accuracy of the detection system of Canon TBA-120FR automatic biochemical analyzer in clinical laboratory were verified,and the verification methods were discussed.Methods By referring to Clinical and Laboratory Standards Institute(CLSI)EP15-A2 document and other documents,the statistical methods given in CLSI EP15-A2 document and the function tools in WPS table software and the statistical tools in SPSS software were used to verify the precision and accuracy of the instrument.Results Under the experimental condition,the laboratory standard deviation(SDl)and laboratory coefficient of variation(CV)calculated by function tools in WPS software were within the range specified by the reagent manufacturers,and the correlation equations calculated by the statistical tools in the SPSS software were well correlated.The linear equations were as follows:aspartate aminotransferase(AST):y=0.941x-1.184,blood glucose(GLU):y=0.972x+0.050,blood urea nitrogen(BUN):y=0.939x+0.051,serum creatinine(SCr):y=1.015x+17.086,uric acid(UA):y=1.059x+8.197,triglycerides(TG):y=1.030x+0.019(all R^(2)>0.99).Conclusions The TBA-120FR automatic biochemical analyzer has been validated to have good precision and accuracy,providing reliable reference test results for clinical use.The validation process is simple and easy to operate,and the validation results are highly reliable.