全自动尿沉渣分析仪Sysmex UF-1000i的性能评价  

Performance evaluation of fully automatic urine sediment analyzer Sysmex UF-1000i

作　　者：方雯丹[1,2] 甘志忠[1,2] 黄晓荣[1,2] 许玉珍[1,2] 

机构地区：[1]解放军第一七五医院 [2]厦门大学附属东南医院检验科,福建漳州363000

出　　处：《检验医学与临床》2015年第6期770-772,共3页Laboratory Medicine and Clinic

摘　　要：目的评价Sysmex UF-1000i全自动尿沉渣分析仪(简称Sysmex UF-1000i)的性能,以探讨其是否符合临床要求。方法按照实验室ISO15189要求,检测白细胞(WBC)计数、红细胞(RBC)计数、上皮细胞(EC)计数、管型(CAST)计数及细菌(BACT)计数5项指标的批内精密度、批间精密度、携带污染率、线性范围、准确度并验证生物参考区间。结果 Sysmex UF-1000i对白细胞(WBC)、红细胞(RBC)、上皮细胞(EC)、管型(CAST)、细菌(BACT)的低值质控批内精密度、高值质控批内精密度、低值质控批间精密度、高值质控批间精密度、低值质控准确度、高值质控准确度,以及RBC、BACT的携带污染率(分别为0.02%和0.00%)均符合厂家要求。WBC、RBC、BACT的线性相关系数r2分别为0.999 4,0.999 8,0.999 8,r2均不低于0.95,线性良好。结论 UF-1000i各项性能均符合ISO15189对性能评价的要求,可应用于临床尿液沉渣的检验。Objective To evaluate the performance of fully automatic urine sediment analyzer Sysmex UF-1000 iin order to discuss whether its performance meets the clinical requirements.Methods The evaluation was performed according to the guidelines established by the accreditation of the laboratory ISO15189.The within-batch and inter-batch precision,carry-over contamination rate,linear range and accuracy of WBC count,RBC count,epithelial cell（EC）count,CAST count and bacterial（BACT）count were analyzed and the biological reference interval was verified.Results The low level control within-batch precisions,high level control within-batch precisions,low level control inter-batch precisions,high level control inter-batch precisions,low level control accuracy,high level control accuracy of WBC,RBC,EC,CAST and BACT and the carryover contamination rates of RBC（0.02%）and BACT（0.00%）were conforming the requirements of the manufacturer.The linear correlation coefficients（r2）of WBC,RBC and BACT were 0.999 4,0.999 8and 0.999 8respectively,which was more than or equal to 0.95 with good linearity.Conclusion The various properties of the UF-1000 imeet the demand of ISO15189,which could be used in clinical urine sediment detection.

关 键 词：UF-1000i全自动尿沉渣分析仪 性能评价 精密度 准确度 携带污染率 线性范围 生物参考区间 

分 类 号：R446.12[医药卫生—诊断学]