论文部分内容阅读
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 value of using National Glycohemoglobin Standardization Program (NGSP) certified samples to traceability and comparability of Hb A1c detection systems in different regions. Methods With reference to NGSP acceptable standards, NGSPⅠ-certified Variant Ⅱ detection system was used as a reference system, and 40 fresh whole blood samples were compared with 8 detection systems in different regions. The incomparable detection system NGSP certified experimental specimens were calibrated, and then 40 cases of fresh whole blood and 10 cases of NGSP competence certified samples for traceability verification. The results of the initial comparison of Variant Ⅱ Turbo, D10 and Capillarys 2 Flex Piercing results comparable, Ultra2 and other five detection system results are not comparable, with NGSP certified specimens for accuracy transfer, comparability significantly improved to an acceptable standard. The coefficient of variation (CV) of all test results was <3.0%, which accorded with the highest acceptable international standard for the dispersion of test results of Hb A1c between different test systems. Conclusion It is an effective way to realize the traceability of Hb A1c system in different areas and ensure the consistency of test results by using the NGSP Ⅰ laboratory accredited testing system as the reference system and using NGSP reference method to assign the certified samples for accuracy transmission.