全自动尿沉渣分析仪FUS-2000的性能评价

Performance evaluation of FUS-2000 automatic urinary sediment analyzer

目的 评价迪瑞全自动尿沉渣分析仪FUS-2000的性能。方法 对FUS-2000的精密度、线性、携带污染率、仪器的自动混匀能力等指标以及尿液样本量与结果的关系进行了评价。并随机选择了194份患者的尿液标本,分别用FUS-2000全自动尿沉渣分析仪及手工定量尿沉渣镜检法,对红、白细胞进行对比分析。结果 低值、高值尿液标本的批内精密度（CV）：红细胞分别为9.05%、5.61%,白细胞分别为7.78%、2.86%。FUS-2000检测值与理论值具有良好的线性关系（红细胞Y=1.0162X-7.4911,r=0.9999;白细胞Y=0.9976X＋22.3442,r=0.9991）。且尿液中白细胞（WBC）、红细胞（RBC）按一定比例稀释后得到的稀释值和理论值的回归方程Y=b X＋a中b均在0.9976~1.0162范围内,a在可接受的范围内且r≥0.99。红、白细胞的携带污染率分别为0.0965%、0%。即刻、放置1、2 h的尿液与放置1、2 h后加人工辅助混匀的尿液中的红细胞、白细胞的计数结果差异无统计学意义（P〉0.05）。同一份样本分成3、4、5、6、7、8 ml后上机检测,各管的红、白细胞计数结果差异无统计学意义。对194份尿液样本的仪器结果和人工镜检结果进行统计学分析,得RBC的Kappa值为0.596,相关系数为0.9031,WBC的Kappa值为0.556,相关系数为0.9300。结论 FUS-2000自动化程度高,报告方式符合标准化要求,验证的各项指标均达到厂家要求范围,可以有效地检测尿液中有形成分。

Objective To evaluate the function and clinical application of FUS-2000 automatic urine sediment analyzer.Methods We evaluated the performance of FUS-2000 automatic urine sediment analyzer by precision,linearity,carryover contamination rate,instrument automatic blending ability index and the relationship between urine sample volume change and the result. And the urine samples of 194 patients were randomly selected; the red blood cells（ RBC） and white blood cells（ WBC） were analyzed by using FUS-2000 automatic urinary sediment analyzer and quantitative microscopic examination of the urine sediment,respectively. Results The within-run precisions of RBC in low and high value samples were9. 05% and 5. 61%,respectively. The within-run precisions of WBC in low and high value samples were 7. 78% and2. 86%,respectively. A good linearity was found between the detected value and theoretical value（ RBC： Y = 1. 0162X-7. 4911,r = 0. 9999; WBC： Y = 0. 9976 X ＋ 22. 3442,r = 0. 9991）. When the urine samples were diluted to a certain percentage,the regression equation for the theoretical and measured value of WBC and RBC was Y = b X ＋ a,in which b was in the range from 0. 9976 to 1. 0162,a was within an acceptable range,and the correlation coefficient r was more than or equal to 0. 99. The carryover contamination rate of RBC as detected by the analyzer was 0. 0965%,and that of WBC was 0%. The difference in urine RBC and WBC count results was not statistical significant among s fresh urine sample,urine sample left standing for 1 to 2 h and artificial auxiliary mixing urine sample after left standing for 1 to 2 h,P〉0. 05.After the same samples were divided into 3,4,5,6,7,8 ml and each tube was detected on the instrument,we found there was no statistically significant difference in RBC and WBC count results. Statistical analysis was performed between instrument result and manual examination results,the RBC Kappa value was 0. 596,the correlation coefficient was 0. 9031,the WBC Kappa value was 0. 556,and the correlation coefficient was 0. 9300. Conclusion FUS-2000 instrument is of high degree of automation. The report meets standardization requirements and the indicators meet the requirements of the manufacturer. FUS-2000 can effectively detect visible components in urine.