SYSMEX UC-3500及UF-4000全自动尿液分析仪智能审核规则与有效性的验证  

The Validation Study of Sysmex UC-3500 and UF-4000 Automatic Urine Analyzer Intelligent Audit Rules and Its Effectiveness

作　　者：陈雪 史光华[1] 姜慧英[1] CHEN Xue;SHI Guanghua;JIANG Huiying(Beijing Coal Group General Hospital Laboratory,Beijing 102300,China)

机构地区：[1]北京京煤集团总医院检验科,北京102300

出　　处：《标记免疫分析与临床》2023年第4期685-689,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的 对SYSMEX干化学UC-3500及流式UF-4000全自动尿液分析仪智能审核规则和有效性进行验证。方法收集2021年5月14日至2021年6月16日的门诊新鲜尿液标本共303份,采用双盲法,验证干化学定性结果等级以及尿有形成分数量范围一致性的复检规则。然后通过再次检测9 206份尿液标本,对规则有效性进行验证分析。结果 经过统计分析,得出真阳性率35.97%(109/303),假阳性率18.48%(56/303),真阴性率42.90%(130/303),假阴性率2.64%(8/303),复检率43.56%(132/303)。经验证,镜检率8.17%(752/9 206),无效审核0.00%,有效拦截率93.58%(8 615/9 206)、仪器无效拦截0.00%,一致性100.00%。结论 假阴性率2.64%(<5%)符合要求,本实验室全自动尿液分析仪的智能审核规则验证通过。无效拦截率及无效审核率为0.00%以及一致(100.00%)性高,本规则有效性验证通过,不需要进行调整,提高尿液检验工作的效率,同时降低复检率,提高临床适用性。Objective The intelligent auditing rules and validity of Sysmex dry chemical UC-3500 and flow UF-4000 automatic urine analyzer were verified.Methods A total of 303 fresh urine samples were collected from Outpatient Clinics from May 14th,2021 to June 16,2021.Double-blind method was used to set up a review rule for the consistency of the qualitative results of dry chemistry and the quantitative range of urinary formed components.Results The results showed that the true positive rate was 35.97%(109/303),while the false positive rate was 18.48%(56/303),the true negative rate was 42.90%(130/303),the false negative rate was 2.64%(8/303),and the reexamination re-examination rate was 43.56%(132/303).The microscopic examination rate was 8.17%(752/9206),while the invalid examination rate was 0.00%,the effective interception rate was 93.58%(8615/9206),the instrument ineffective interception rate was 0.00%,and the consistency was 100.00%.Conclusion Our results show that the false negative rate is 2.64%,which meets the requirements.The intelligent audit rules of the automatic urine analyzer in our laboratory has been verified.The invalid interception rate and the invalid audit rate are 0.00%and the consistency(100.00%)is high.The validity of these rules is verified and no adjustments are required.After screening the specimen needed by the instrument,the efficiency of urine examination can be improved,and the re-examination rate can be decreased,so the clinical applicability can be improved.

关 键 词：复检规则 尿液干化学分析 尿液流式分析 假阳性 假阴性 

分 类 号：R446.12[医药卫生—诊断学]