摘要
目的评价UF-4000全自动尿有形成分分析仪性能。评价两种方法学检测尿中红细胞(RBC)、白细胞(WBC)计数结果的一致性,为本实验室建立比对方案提供依据。方法依据CNAS-CL02-A002:2018《医学实验室质量和能力认可准则在体液学检验领域的应用说明》,对本实验室UF-4000有形成分分析仪进行性能评价。依据《全国临床检验操作规程》尿液细胞计数指导方案,收集马鞍山市人民医院2021年10月至2022年7月门诊、住院患者的新鲜中段尿120份,以不离心新鲜尿液计数板(Fuchs-Rosenthal计数板)定量法做为参考方法,全自动尿液有形成分分析仪法为评估方法。采用Wilcoxon符号秩检验及Spearman相关分析,采用Passing-Bablok回归分析模型进行拟合,采用Bland-Altmen差异图评价一致性。结果UF-4000全自动尿有形成分分析仪精密度、正确度、携带污染率、线性和临床可报告范围、参考区间验证均符合要求。在22.50~1075.47个/μL范围内,2种方法学的尿红细胞检测结果具有良好的一致性(Y=3.077+0.966X,r=0.993),差异无统计学意义(Z=-1.298,P=0.194)。RBC数据使用比值Bland-Altmen法分析,100%的点在一致性界限内。在27.97~603.76个/μL的范围内,2种方法学的尿白细胞检测结果具有良好的一致性(Y=-2.387+1.037X,r=0.993),差异无统计学意义(Z=-0.935,P=0.350)。WBC数据使用比值Bland-Altmen法分析,98.33%的点在一致性界限内。结论UF-4000全自动尿液有形成分分析仪性能良好,检测尿液红、白细胞与参考方法具有可比性,准确性和一致性较好,可满足临床检测需要。
Objective To evaluate the performance of UF-4000 automated urine sediment analyzer,and to evaluate the consistency of urine red blood cell(RBC)and white blood cell(WBC)counts between the two methods,and to further provide a reference basis for the establishment of a comparison protocol in our laboratory.Methods According to the requirements of CNAS-CL02-A002:2018:Accreditation Criteria for the Quality and Ability of Medical Laboratories,the performance evaluation of UF-4000 automated urine sediment analyzer was validated.According to the urine cell counting guidance scheme of the National Clinical Laboratory Operating Procedures,120 fresh midstream urine samples were collected from Outpatients and Inpatients Departments in Maanshan People’s Hospital from October,2021 to July,2022.For the comparative analysis,the quantitative method of non-centrifugal fresh urine counter plate was used as the reference method,and the urine sediment analyzer method was used as the evaluation method.Passing-Bablok regression analysis was used for model fitting,and Wilcoxon signed rank test and Spearman correlation analysis were performed,and Bland-Altmen difference plots was used to evaluate levels of agreement.Results The precision,accuracy,carrying contamination rate,linear and clinically reportable range,and reference interval validation of UF-4000 urine sediment analyzer met the standard requirements.In the range of 22.50-1075.47/μL,the results of RBC detected by the two methods were consistent(Y=3.077+0.966 X,r=0.993).There was no statistically significant difference between results of the two groups(Z=-1.298,P=0.194).The ratio Bland-Altmen method was used to analyze RBC data,and 100%of the points were within the 95%limits of agreement.In the range of 27.97-603.76/μL,the results of WBC detected by the two methods were consistent(Y=-2.387+1.037 X,r=0.993).There was no statistically significant difference between results of the two groups(Z=-0.935,P=0.350).The ratio Bland-Altmen method was used to analyze WBC data,and 98.33%o
作者
朱翔
殷贤斌
陶朝云
李之珍
武萍
谢萍
童雪娥
许大海
张慧
王媛媛
王慧
黄小玲
ZHU Xiang;YIN Xianbin;TAO Zhaoyun;LI Zhizhen;WU Ping;XIE Ping;TONG Xue’e;XU Dahai;ZHANG Hui;WANG Yuanyuan;WANG Hui;HUANG Xiaoling(Maanshan Center for Clinical Laboratory,Maanshan 243000,China;Maanshan Center forPhysical Examination of People’s Hospital,Maanshan 243000,China)
出处
《标记免疫分析与临床》
CAS
2024年第5期941-947,共7页
Labeled Immunoassays and Clinical Medicine
基金
马鞍山科技计划项目(编号:YL2021-32)。
