尿液复合室内质控物的研制与评价  

Preparation and evaluation for urine internal multiplex QC material of NAG and UMA

作　　者：袁咏梅[1] 刘和录[1] 何亚[1] 杨鸿雅[1] 於艳霞[1] 林洁[1] 杨庆伟[1] 

机构地区：[1]广州医学院附属深圳沙井医院检验科,广东深圳518104

出　　处：《国际检验医学杂志》2013年第15期1986-1987,1989,共3页International Journal of Laboratory Medicine

基　　金：2012年深圳市宝安区科技计划项目(2012135)

摘　　要：目的研制出包含(NAG)和尿微量清蛋白(UMA)两项的复合室内质控物,并初步评价其质量。方法收集临床肾病患者新鲜尿液,经过处理,制成包含尿NAG和尿UMA两个项目的复合室内质控物;并依据CNAS-GLO3及ISOGuide35的要求,对研制的质控物均匀性、稳定性进行评价。结果均一性检测NAG和UMA计算的F值分别为2.32和1.54,均小于F0.05(9.10);稳定性检测NAG和UMA所得t值均小于t0.05(29)。结论本次研制的尿NAG和UMA2项复合室内质控物在合适的保存条件下,具备较好的均一性与稳定性,符合临床使用要求。Objeetive To develop a appropriate intra laboratory QC material for NAG and UMA and then verify the clinical usa- bility of it. Methods Gather clinical fresh urine samples of kidney patients,which were made into QC multiplex material of NAG and UMA. And then according to CNAS-GLO3 and ISO Guide 35,homogeneity and stability of the quality control material were evaluated. Results The values of homogeneity F of NAG abd UMA were 2. 32 and 1. 54, respectively, which were less than F0.05（9.10） ;the values of stability t of NAG and UMA were less than t0.05（29）. Conclusion The self-made intra laboratory QC material for NAG and UMA is stable and homogeneous,and can be used for intra laboratory quality control in clinical laboratories.

关 键 词：自制复合质控物 均一性 稳定性 

分 类 号：R446.1[医药卫生—诊断学]