对4个HbA1c测定系统的精密度和正确度验证

摘要

Objective To verify the performance for precision and trueness of 4 glycated hemoglobin measurement systems, to determine whether relevant requirements are fulfilled, and to provide guidelines for clinical laboratory staff and clinicians . Methods A simple experiment protocol was applied to verify in five days the performance for precision and trueness of 4 HbA1c measurement systems, three of which were based on ion-exchange high-performance liquid chromatography and one based on immune turbidimetric assay, Within-run and within-lab precisions and trueness were calculated and evaluated against requirements. Results The within-run precision and within-laboratory CVs of four systems were 0.26%~1.02% and 0.28%~1.5% respectively. The bias of four systems were -0.34% HbA1c~ 0.41% HbA1c (NGSP value) and -0.14% HbAjc ~ 0.61% HbA1c(value derived from the IFCC-NGSP equation). Conclusions The performance of within-run and intra-lab precision and trueness of 4 systems meets relevant requirements and clinical needs.%目的 验证4个HbA1c测定系统的正确度、精密度,以判断是否符合相关要求,为临床实验室的使用提供相关依据.方法 采用一种简便的实验方案,在5d内,对3个基于离子交换高效液相色谱法和1个基于免疫比浊法原理的HbA1c测定系统进行精密度和正确度验证实验,计算各个系统的批内精密度、实验室内精密度及测定结果的正确度.结果 4个系统的批内精密度CV为0.26％～1.02％,实验室内精密度CV为0.28％～1.50％;4个系统测定标准物质的均值[美国国家HbA1 c标准化计划( NGSP)值]和标准物质定值的偏倚为-0.34％ HbA1 c～0.41％HbA1c,与国际临床化学与检验医学联合会( IFCC)定值导出的NGSP值的偏倚为-0.14％ HbA1 c～0.60％HbA1 c.结论 4个系统的批内精密度和实验室内精密度及正确度性能符合相关要求,能满足临床工作的需要.