UF-500i全自动尿沉渣分析仪检测系统的性能验证

Performance verification of the detection system of UF-500i automatic urinary sediment analyzer

目的对日本Sysmex公司UF-500i型全自动尿沉渣分析仪检测系统的主要分析性能进行验证。方法对该仪器检测项目白细胞(WBC)、红细胞(RBC)、上皮细胞(EC)及细菌(BACT)进行性能验证。利用变异系数对精密度进行评价;利用携带污染率对携带污染情况进行评价;利用线性方程对检测项目的线性范围进行评价;利用相对偏差对仪器间的结果比对进行评价。结果该仪器检测项目WBC及RBC的批内及批间精密度均<10%、EC的批内及批间精密度均<30%、BACT的批内及批间精密度均<20%,各检测项目的批内及批间变异均在可接受范围内;BACT携带污染率>0.05%,不符合要求,其他检测项目携带污染率均<0.1%,符合仪器性能要求;线性验证标本按一定比例稀释后将所得理论值与实测值进行回归分析,b值均介于0.97～1.03范围内,r均>0.975,符合线性要求;与参比仪器各检测项目的相对偏差均<仪器厂家提供的1/2允许总误差(TEa),符合仪器性能要求。结论 UF-500i检测系统的精密度、携带污染率、线性范围及仪器间比对结果等基本符合实验诊断学实验室的要求,可用于临床标本的检测。

Objective To verify the main analysis performance of the UF-500i automatic urinary sediment analyzer,Sysmex,Japan. Methods White blood cell（WBC）,red blood cell（RBC）,endothelial cell（EC） and bacterium（BACT） were selected to verify the performance of the equipment. The precision was evaluated by coefficient of variation. Carryover circumstance was evaluated by carryover rates. Linear range was evaluated by regression equation,and the comparison of different equipments was evaluated by relative deviation. Results The within-run and between-run precisions of WBC and RBC were 〈10%. The within-run and between-run precisions of EC and BACT were 〈30% and 〈20%,respectively. All the within-run and between-run precisions of selected testing items were within an acceptable range. The carryover rates of BACT were 〉0.05% without the requirements. All the other carryover rates of selected testing items were 〈0.1% within the requirements. The linear verification results got the regression equation of the theoretical and measured values after certain dilution,in which b value was within the range of 0.97-1.03（r〉0.975）. The relative deviation in different equipments was 〈1/2 total errors（TEa） provided by equipment production. Conclusions The precision,carryover rates,the comparison results in different equipments and the linearity of the selected testing items of the UF-500i automatic urinary sediment analyzer meet the requirements of the laboratories in clinical diagnosis and have the clinical application significance.