NGSP认证标本在实现不同地区HbA1c检测系统溯源性和可比性中的应用  

Application of certified samples from NGSP for achieving the traceability and comparability of Hb A1c detection systems from different regions

作　　者：张德才[1] 温冬梅[1] 张秀明[1] 王伟佳[1] 索明环[1] 陈亚琼[1] 

机构地区：[1]中山大学附属中山医院检验医学中心,广东中山528403

出　　处：《临床检验杂志》2016年第9期703-705,共3页Chinese Journal of Clinical Laboratory Science

基　　金：中山市科技计划项目(20132A091,2015B1013)

摘　　要：目的探讨美国国家糖化血红蛋白标准化计划(NGSP)认证标本在实现不同地区糖化血红蛋白(Hb A1c)检测系统溯源性和可比性中的应用价值。方法参照NGSP的可接受标准,以通过NGSPⅠ级实验室认证的VariantⅡ检测系统为参比系统,用40例新鲜全血对不同地区的8个检测系统进行方法学比对,对不可比的检测系统用NGSP认证实验标本进行校准,再用40例新鲜全血和10例NGSP能力认证标本进行溯源性验证。结果初步比对VariantⅡTurbo、D10及Capillarys 2 Flex Piercing结果可比,Ultra2等5个检测系统结果不可比,用NGSP认证标本进行准确度传递后,可比性显著提高,达到可接受标准。所有检测系统检测结果的变异系数(CV)均<3.0%,符合国际对不同检测系统间Hb A1c检测结果离散度的最高可接受标准。结论以通过NGSPⅠ级实验室认证的检测系统作为参比系统,采用NGSP参考方法赋值的认证标本进行准确度传递是实现不同地区Hb A1c检测系统量值溯源性及保证检测结果一致性的有效途径。Objective To explore the application of certified reference material from National Glycohemoglobin Standardization Program （NGSP） for achieving the traceability and comparability of HbA1 c detection systems from different regions of China. Methods Ac- cording to the acceptance criteria of NGSP, the HbAlc detection system, Variant Ⅱ Turb was used as the reference system. Eight HbA1 c detection systems from different regions were compared by using 40 fresh blood samples. The incompatible systems in which the traceability was out of calibration were verified by 40 fresh blood samples and 10 NGSP capability certification samples following cali- bration by NGSP certified experimental material. Results The results of systems Variant Ⅱ Turbo, D10 and Capillarys 2 Flex Pierc- ing were comparable with Variant Ⅱ , but the the results of 5 detection systems, such as Ultra2, were incomparable with Variant Ⅱ. After disseminating the value of the NGSP blood samples, the comparability of these incomparable systems was obviously improved and achieved the acceptable standards. Condasion The detection system certified by NGSP grade I laboratory should be used as the comparative reference system. The certified samples assigned by NGSP reference method should be used for dissemination of the value. These ways may be effective to improve the traceability and comparability of different HbAlc detection system from different regions.

关 键 词：美国国家糖化血红蛋白标准化计划(NGSP) 量值传递 糖化血红蛋白 溯源性 可比性 

分 类 号：R446[医药卫生—诊断学]