USCANNER(E)尿沉渣分析仪参考区间建立及临床适用性探讨  

The Development of Reference Interval of USCANNER(E)Urine ParticlesAnalyzer and the Evaluation of Its Clinical Application

作　　者：钟日辉[1] 曾蔼琦 丁睿[1] 黄利思[1] 孙龙乔子 段朝晖[1] ZHONG Rihui;ZENG Aiqi;DING Rui;HUANG Lisi;SUN Longqiaozi;DUAN Chaohui(Department of Clinical Laboratory,Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangzhou 510120,China;Department of Endocrinology and Metabolism,Shunde Hospital of Southern Medical University,Foshan 528308,China)

机构地区：[1]中山大学孙逸仙纪念医院检验科,广东广州510120 [2]南方医科大学顺德医院内分泌与代谢科,广东佛山528308

出　　处：《标记免疫分析与临床》2023年第5期840-845,共6页Labeled Immunoassays and Clinical Medicine

基　　金：国家重点研发计划项目(编号:2021YFC2009300,2021YFC2009302)。

摘　　要：目的建立USCANNER(E)尿沉渣分析仪(简称USE)常用参数参考区间;对其进行性能验证;分别比较USE和IQ200尿沉渣分析仪(简称IQ200)与人工镜检结果一致性。方法筛选331例健康标本进行检测,建立常用参数参考区间;测定USE携带污染率;另收集标本147例,同时用USE和IQ200检测,其中92例进行人工镜检。将USE分别与IQ200和人工镜检作一致性分析,评估USE诊断效能。结果在95%可信区间内USE参考区间为:红细胞:0~6个/μL(男),0~15个/μL(女);白细胞:0~13个/μL(男),0~22个/μL(女);鳞状上皮细胞:0~8个/μL(男),0~29个/μL(女);非鳞状上皮细胞:0~1个/μL(不分性别);管型、结晶、细菌及真菌为阴性。未检出携带污染。USE与IQ200经人工修饰后红细胞、白细胞的Kappa值均≥0.85,其余项目在0.54~0.72之间。USE人工修饰后与人工镜检相比,除了非鳞状上皮细胞和结晶外,其余项目Kappa值均≥0.77。USE各项目符合率均≥88%;红细胞、白细胞、鳞状上皮细胞的受试者工作特征曲线的曲线下面积为0.973、0.998、0.941。结论本研究建立的USE参考区间可供参考;USE对尿液有形成分的总体检测性能良好,适用于日常临床样本的初筛检查,但仍需配合人工镜检以提高结果的准确性。Objective To develop the reference interval of common items of the USCANNER(E)urine particles analyzer(USE),and to evaluate its analytic performance.To compare the results of USE to IQ200 urine sediment analyzer(IQ200)and artificial microscopy.Methods 331 healthy specimens were selected for testing and establishing the reference interval of common items.The carry-over rate of USE was verified.Another 147 specimens were collected and tested by USE and IQ200 at the same time.92 of them were examined by manual microscopy.The results of USE and IQ200 were compared by Kappa consistency analysis,and the results between USE and manual microscopy were compared as well.The diagnosis efficiency of USE was evaluated.Results Within the 95%confidence interval,the USE reference interval was:red blood cells:0-6 cells/μL(male),0-15 cells/μL(female),white blood cells:0-13 cells/μL(male),0-22 cells/μL(female),squamous epithelial cells:0-8 cells/μL(male),0-29 cells/μL(female),non-squamous epithelial cells:0-1 cells/μL(regardless of gender),casts,crystals,bacteria and fungi were all negative.No carry-over was detected.Manual images review results showed that Kappa values of red blood cells and white blood cells between USE and IQ200 was≥0.85,and Kappa values of other items were between 0.54-0.72.Except for squamous epithelial cells and crystals,Kappa values of remaining items between USE and artificial microscopy were all≥0.77 after manual images review.The consistency rates of all items in USE were above 88%.The area under the receiver operating characteristic curve of red blood cells,white blood cells,and squamous epithelial cells were 0.973,0.998,and 0.941,respectively.Conclusion The reference interval of USE established in this study could be useful for clinical practices.USE exhibits a generally good performance of detecting urine sediments and is suitable for routine screening in clinical work,but it still needs to be combined with manual microscopy to improve accuracy.

关 键 词：尿沉渣 人工镜检 USCANNER(E)尿沉渣分析仪 IQ200尿沉渣分析仪 

分 类 号：R446.12[医药卫生—诊断学]