对4个HbA_1c测定系统的精密度和正确度验证

Verification of performance for precision and trueness of four HbA_1c measurement systems

目的验证4个HbA_1c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5 d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HbA_1c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HbA_1c标准化计划(NGSP)值]和标准物质定值的偏倚为-0.34%HbA_1c～0.41%HbA_1c,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%HbA_1c～0.60%HbA_1c。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。

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 HbA1 c 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% HbAlc 0. 41% HhA1 c （NGSP value） and - 0. 14 % HbA1 c - 0. 61% HbA1 c （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.