尿沉渣白细胞计数标准物质的研制  

Development of Reference Material for White Blood Cell Count in Urine Sediment

作　　者：刘瑛颖[1] 张玲[1] 杨乔斯 LIU Ying-ying;ZHANG Ling;YANG Qiao-si(National Institute of Metrology,Beijing,100029,China;Dirui Industrial CO.LTD.,Changchun,Jilin 130000,China)

机构地区：[1]中国计量科学研究院,北京100029 [2]迪瑞医疗科技股份有限公司,吉林长春130000

出　　处：《计量学报》2022年第3期427-432,共6页Acta Metrologica Sinica

基　　金：国家重点研发计划项目(2017YFF0204601)。

摘　　要：运用扫描电子显微成像技术拍摄经过固定处理的人血液白细胞,确定其细胞形态真实性后,分散重悬制备成尿沉渣白细胞计数标准物质候选物。使用高通量显微成像法和流式细胞术对标准物质候选物进行联合定值;通过方差分析法和回归曲线法考察了其均匀性和稳定性;与20份临床样本进行了评价基质效应的互通性验证,并对标准物质候选物进行了不确定度评定。研制得到的尿沉渣白细胞计数标准物质浓度水平为(516.0±50.5)cells/μL(k=2),均匀性和稳定性良好,4℃可保存12个月,与临床样本具有良好的互通性。该标准物质可用于临床检测中的全自动尿沉渣分析仪中白细胞项目的周期校准、质量控制,以及相关检测项目的分析方法确认和验证。After the cell morphology of the fixed human white blood cells was investigated by scanning electron microscopy,the reference material candidate of white blood cell count in urine sediment was prepared.High throughput microscopic imaging technology and flow cytometry were used to jointly determine the value of reference material candidates;the homogeneity and stability were investigated by variance analysis and regression curve;the interoperability of matrix effect was verified with 20 clinical samples,and the uncertainty of reference material was evaluated.The concentration of the standard substance for white blood cell count in urine sediment is(516.0±50.5)cells/μL(k=2),which has good uniformity and stability.It can be stored for 12 months at 4℃,and has good interoperability with clinical samples.The reference material can be used for the periodic calibration and quality control of white blood cell count by the automatic urine sediment analyzer in clinical detection,as well as the confirmation and validation of analytical methods of relevant tests.

关 键 词：计量学 白细胞计数 尿沉渣 标准物质 高通量显微成像法 流式细胞术 不确定度 

分 类 号：TB99[一般工业技术—计量学]