用TOSOH HLC-723 G8型糖化血红蛋白仪检测糖化血红蛋白的精密度及正确度  

The precision and accuracy of hBA1c were measured by TOSOH HLC-723 G8 hBA1C instrument

作　　者：郭胜利 郭丽丽[2] 李守霞[2] GUO Shengli;GUO Lili;LI Shouxiai(Department of Clinical Laboratory,Handan Steel Hospital,Handan 056001;Department of Clinical Laboratory,Handan Central Hospital,Handan 056001)

机构地区：[1]邯郸邯钢医院检验科,河北邯郸056001 [2]邯郸市中心医院检验科,河北邯郸056001

出　　处：《当代医药论丛》2022年第3期143-145,共3页

摘　　要：目的:评价用TOSOH HLC-723 G8型糖化血红蛋白仪检测糖化血红蛋白的精密度及正确度。方法:参照美国临床和实验室标准协会制定的相关标准、WS/T 492-2016、WS/T 420-2013、WS/T 402-2012、YY/T 1246-2014等中国行业标准中的相关方法验证用TOSOH HLC-723 G8型糖化血红蛋白仪(采用高效液相色谱法)检测糖化血红蛋白的精密度及正确度。结果:1)低(5.0%)、高(9.947%)两个糖化血红蛋白浓度水平血样的实测批内不精密度分别为0.73%、0.519%,总不精密度分别为0.76%、0.779%,均在实验室允许范围(批内不精密度<2.0%,总不精密度<2.667%)内,检测精密度验证通过。2)低〔(5.02±0.15)%〕、中〔(6.86±0.15)%〕、高〔(9.34±0.21)%〕三个糖化血红蛋白浓度水平参考物质的赋值分别落在验证区间4.885%~5.129%、6.728%~7.194%、9.266%~9.622%范围内,检测正确度验证通过。结论:用TOSOH HLC-723 G8型糖化血红蛋白仪检测糖化血红蛋白的精密度及正确度均符合相关要求。Objective:To evaluate the accuracy and precision of the TOSOH HLC-723 G8 glycosylated hemoglobin analyzer for the detection of glycosylated hemoglobin.Methods:TOSOH HLC-723 was used to verify the method according to the relevant standards developed by the American Association of Clinical and Laboratory Standards,and the relevant standards of Chinese industry such as WS/T 492-2016,WS/T 420-2013,WS/T 402-2012,YY/T 1246-2014 G8 hba1c instrument(high performance liquid chromatography)was used to measure the precision and accuracy of hba1c.Results:1)The measured in-batch imprecision of the blood samples with low(5.0%)and high(9.947%)hba1c concentration levels were 0.73%and 0.519%,respectively,and the total imprecision was 0.76%and 0.779%,respectively,both within the allowable range of the laboratory(in-batch imprecision<2.0%,total imprecision<2.667%).The detection precision was verified.2)The values of low[(5.02±0.15)%],medium[(6.86±0.15)%]and high[(9.34±0.21)%]hBA1C concentrations were in the validation range of 4.885%-5.129%,6.728%-7.194%and 9.266%-9.622%,respectively,the correctness of detection is verified.Conclusion:TOSOH HLC-723 G8 hBA1c instrument can be used to determine the accuracy and precision of hBA1C.

关 键 词：TOSOH HLC-723 G8型糖化血红蛋白仪 高效液相色谱法 糖化血红蛋白 精密度 正确度 

分 类 号：R446[医药卫生—诊断学]