TOSOH HLC-723 G8检测糖化血红蛋白性能评价
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摘要
目的对TOSOHHLC-723G8用于临床检测糖化血红蛋白性能评价。方法精密度验证采用EP15-A2、WS/T 461-2015方法 ,正确度验证采用与参考实验室结果比对,线性验证采用W S/T 420-2013方法 ,携带污染采用连续进样高值、低值样本各三次计算携带污染率,统计并分析检测结果。结果短期精密度低值为0.86%、高值为0.98%,长期精密度低值为0.98%、高值为0.69%;与参考仪器结果高度相关(r=0.999,r~2=0.998,P=0.000);5.2%～15.2%范围线性良好(y=1.0115x-0.0505,r~2=0.9997);携带污染率小(k=1.00%)。结论 TOSOHHLC-723G8精密度高,正确度、线性良好,携带污染率低,可用于临床检测糖化血红蛋白。
Objective To evaluate the performance of TOSOH HLC-723 G8 analyzer for clinical detection of HbA_(1C).Methods Precision verification was based on EP15-A2 and WS/T461-2015 methods.Correctness verification was compared with the results of Bio-Rad D 10 reference detection system.The WS/T 420-2013 verification method was used for linear verification,and the carrying rate was three times with high and low values of continuous sampling.Results The low value of short term precision was 0.86% and the high value,0.98%.The long-term precision low value was 0.98% and the high value,0.69%,which is highly correlated to the results tested by the reference instrument(r =0.999,r~2=0.998,P =0.000).Additionally,a good linearity in the range of 5.2% and 15.2%(y =1.0115 x-0.0505,r =0.9997) and low rate of carryover(k =1.00%) were noted.Conclusion TOSOH HLC-723 G8 has a high precision,good linearity and low pollution rate and can be used for clinical detection of HbA_(1C).
Objective To evaluate the performance of TOSOH HLC-723 G8 analyzer for clinical detection of HbA_(1C).Methods Precision verification was based on EP15-A2 and WS/T461-2015 methods.Correctness verification was compared with the results of Bio-Rad D 10 reference detection system.The WS/T 420-2013 verification method was used for linear verification,and the carrying rate was three times with high and low values of continuous sampling.Results The low value of short term precision was 0.86% and the high value,0.98%.The long-term precision low value was 0.98% and the high value,0.69%,which is highly correlated to the results tested by the reference instrument(r =0.999,r~2=0.998,P =0.000).Additionally,a good linearity in the range of 5.2% and 15.2%(y =1.0115 x-0.0505,r =0.9997) and low rate of carryover(k =1.00%) were noted.Conclusion TOSOH HLC-723 G8 has a high precision,good linearity and low pollution rate and can be used for clinical detection of HbA_(1C).
引文
1 American Diabetes Association.Standards of medical care in diabetes-2010[J].Diabetes care,2010,33(suppl 1):S11-S69.
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3居漪.再谈糖化血红蛋白[J].检验医学,2 0 1 5,3 0(6):547-551.
4 Jean-Paul Chapelle,Jelda Teixeira,Diane Maisin,et al.Multicentre evaluation of the Tosoh HbA1c G8 analyser[J].Clinical Chemistry and Laboratory Medicine,2010,48(3):365-371.
5 CLSI EP15-A2.User verification of performance for precision and trueness;approved guideline-second edition[S].CLSI,2005.
6 WS/T 492-2016.临床检验定量测定项目精密度与正确度性能验证[S].国家卫生和计划生育委员会,2016.
7 WS/T461-2015.糖化血红蛋白检测[S].国家卫生和计划生育委员会,2015.
8 WS/T420-2013.临床实验室对商品定量试剂盒分析性能的验证[S].国家卫生和计划生育委员会,2013.
9宋银丹,段勇.糖化血红蛋白检测标准化的研究进展[J].实验与检验医学,2013,31(2):108-110.
10王冬环.糖化血红蛋白检测标准化与中国现状[J].中国实用内科杂志,2016,36(10):481-844.
11冯仁丰.糖化血红蛋白标准化和检测准确度现状[J].检验医学,2016,31(6):437-441.
12王冬环,陈文祥,张传宝,等.糖化血红蛋白实验室检测指南[J].中国糖尿病杂志,2013,21(8):72-678.
13金宏伟,傅建国,王欣欣,等.厦门地区10487名成人糖化血红蛋白水平调查分析[J].中华检验医学杂志,2014,37(12):912-916.
14中华医学会糖尿病学分会.中国2型糖尿病防治指南(2013年版)[J].中国糖尿病杂志,2014,22(8):2-42.
2章晓燕,王薇,赵海建,等.全国糖化血红蛋白正确度验证室间质评不同检测系统的结果分析[J].中华检验医学杂志,2015,38(11):742-745.
3居漪.再谈糖化血红蛋白[J].检验医学,2 0 1 5,3 0(6):547-551.
4 Jean-Paul Chapelle,Jelda Teixeira,Diane Maisin,et al.Multicentre evaluation of the Tosoh HbA1c G8 analyser[J].Clinical Chemistry and Laboratory Medicine,2010,48(3):365-371.
5 CLSI EP15-A2.User verification of performance for precision and trueness;approved guideline-second edition[S].CLSI,2005.
6 WS/T 492-2016.临床检验定量测定项目精密度与正确度性能验证[S].国家卫生和计划生育委员会,2016.
7 WS/T461-2015.糖化血红蛋白检测[S].国家卫生和计划生育委员会,2015.
8 WS/T420-2013.临床实验室对商品定量试剂盒分析性能的验证[S].国家卫生和计划生育委员会,2013.
9宋银丹,段勇.糖化血红蛋白检测标准化的研究进展[J].实验与检验医学,2013,31(2):108-110.
10王冬环.糖化血红蛋白检测标准化与中国现状[J].中国实用内科杂志,2016,36(10):481-844.
11冯仁丰.糖化血红蛋白标准化和检测准确度现状[J].检验医学,2016,31(6):437-441.
12王冬环,陈文祥,张传宝,等.糖化血红蛋白实验室检测指南[J].中国糖尿病杂志,2013,21(8):72-678.
13金宏伟,傅建国,王欣欣,等.厦门地区10487名成人糖化血红蛋白水平调查分析[J].中华检验医学杂志,2014,37(12):912-916.
14中华医学会糖尿病学分会.中国2型糖尿病防治指南(2013年版)[J].中国糖尿病杂志,2014,22(8):2-42.