3种便携式血糖检测仪的分析性能评价

Evaluation on analytic performance of three kinds of portable blood glucose meter

目的验证3种便携式血糖仪的精密度、正确度、线性范围等分析性能。方法 3种便携式血糖仪分别参照美国临床实验室标准化协会（CLSI）EP15-A2推荐方案用配套质控液作为实验标本验证批内和日间精密度;参照《医疗机构便携式血糖检测仪管理和临床操作规范（试行）》血糖仪比对方案一：静脉血样比对试验,通过方法学比对验证正确度;参照CLSI EP6-A2推荐方案以等浓度间隔不同葡萄糖浓度的样品验证线性范围。结果罗氏血糖仪低值、高值批内CV%分别为2.31%、1.92%,雅培血糖仪低值、高值批内CV%分别为2.96%、2.69%,泰尔茂血糖仪低值、高值批内CV%分别为2.60%、2.40%,罗氏、雅培和泰尔茂低值质控液批间SD分别为0.08、0.09、0.09,高值质控液批间CV%分别为2.10%、2.90%、2.90%。3种血糖仪比对试验结果显示,葡萄糖浓度小于4.2mmol/L标本偏差绝对值均数分别为0.14%、0.18%和0.26%,葡萄糖浓度大于或等于4.2mmol/L标本偏倚绝对值均数分别为3.85%、4.16%和6.85%。3种便携式血糖仪精密度、正确度均符合《医疗机构便携式血糖检测仪管理和临床操作规范（试行）》要求,亦符合卫生部临床检验中心便携式血糖仪室间质评评价标准的可接受范围。3种便携式血糖仪线性范围分别为0.6~33.3、1.0~33.3、1.1~27.7mmol/L,达到厂家声明范围。结论本研究的3种便携式血糖检测仪精密度、正确度和线性范围符合厂家声明标准,性能满足卫生行业管理机构和临床使用要求。

Objective To verify the analytical performance of precision,accuracy and linearity range in three kinds of portable blood glucose meter.Methods The within-run precision and between-run precision in 3 kinds of portable blood glucose meter were verified by referring to the scheme recommended by CLSI EP15-A2 and with the matched quality control solution as the experimental sample;the accuracy was verified through the methodological comparison and referring to the comparison scheme 1of blood glucose meter：the venous blood sample comparison test in the Portable Blood Glucose Meter Management and Clinical Operation Standard of Medical Institutions（Trial）;the linearity range was verified by different glucose concentrations of sample with the same concentration interval refering to the scheme recommended by CLSI EP6-A2.Results The within-run precision CV% for low value and high value for the Roche blood glucose meter were 2.31% and 1.92% respectively,which for the Abbott blood glucose meter were 2.96% and 2.69% respectively,and which for the Terumo blood glucose meter are 2.60% and2.40% respectively.The between-run SD of low value quality control solution in three kinds of portable blood glucose meter were 0.08,0.09 and 0.09 respectively.The between-run CV% of the high value were 2.10%,2.90% and2.90% respectively.The results of comparison tests showed that when the blood glucose concentration〈4.2mmol/L,the mean absolute values of sample biases were 0.14%,0.18% and 0.26%,while when the blood glucose concentration≥4.2 mmol/L,which were 3.85%,4.16% and 6.85% respectively.The precision and accuracy in these 3kinds of portable blood glucose meter all conformed to the requirements of the Portable Blood Glucose Meter Management and Clinical Operation Standard of Medical Institutions（Trial）and also conformed to the acceptable ranges of the external quality assessment standards issued by the Clinical Laboratory Center of Ministry of Health.The linearity ranges of three kinds of instruments were 0.6-33.3,1.0-33.3,1.1-27.7 mmol/L respectively,which reached the declaration scope by the manufacturers.Conclusion The precision,accuracy and linearity ranges of three kinds of portable blood glucose meter are accorded with the declaration scope by the manufacturers and the performance meets the requirements of the health industrial management institutions and clinical application.