血红蛋白测定参考方法实验初探

摘要

目的 进行血红蛋白(Hb)测定参考方法实验研究,为开展Hb测定正确度验证试验提供保障.方法 按照国际血液学标准化委员会(ICSH)要求,在UV-2550分光光度计上使用日本临床化学参考物质标准研究院赋值的有证低、中、高3个浓度水平Hb参考物质和2016年上海市临床实验室第1次室间质评血细胞分析正确度验证的2个调查样品,进行Hb测定总精密度、准确度和传递性等实验研究.结果5种样品Hb测定参考方法总精密度(CV)＜0.5％,3个浓度水平Hb参考物质准确度符合参考物质证书要求,61 5家临床实验室测定Hb总均值((x))和不同品牌血液分析仪Hb测定值与参考方法赋值之间偏移＜2.7％.结论 用UV-2550分光光度计进行Hb测定参考方法实验研究的精密度、准确度均符合要求,Hb浓度能很好地传递到厂商常规血液分析仪.%Objective To investigate the reference method for hemoglobin (Hb) determination,and to provide a reference for trueness verification of Hb determination.Methods According to the requirements of the International Council for Standardization in Haematology (ICSH),UV-2550 spectrophotometer was used for Hb reference materials with low,medium and high levels being labeled by Japanese Reference Material Institute for Clinical Chemistry Standards and 2 trueness verification samples in the first External Quality Assessment of Shanghai Clinical Laboratory 2016.The precision,accuracy and comparability were analyzed.Results The total precision (CV) of the 5 samples using the reference method for Hb determination was ＜0.5％.The accuracy of Hb reference materials with 3 levels met the certification of reference materials.The bias of Hb determination total means ((x))determined by 615 clinical laboratories and Hb determination values by hematological analyzers with different brands was ＜2.7％,compared to reference method assignments.Conclusions The precision and accuracy of reference method for Hb determination by UV-2550 spectrophotometer meet related requirements.The level of Hb can be delivered well to routine hematological analyzers.