全自动尿液分析工作站复检规则的制定及应用评估  

Establishment and evaluation of the review criteria of automatic urine analysis workstations

作　　者：吴晓华[1] 肖迨 李秋晨[1] 柯群[1] 

机构地区：[1]上海交通大学医学院附属第一人民医院检验科,200080

出　　处：《中华检验医学杂志》2014年第6期465-468,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的：制定针对全自动尿液分析工作站检测结果的尿液镜检复检规则。方法收集2013年3至5月上海市第一人民医院门诊和住院尿液常规标本共3154份，用于建立复检规则。用全自动尿液分析工作站对3154份尿液标本进行干化学和有形成分分析；同时采用双盲法进行显微镜检查，以此结果的平均值为判断标准，对3154份尿液标本的检测结果进行复检规则的设置。根据自动化尿液分析工作站的检测方法，设计制定4种方案如下：（1）方案1：单纯干化学尿液分析仪检测的潜血（BLD）、中性粒细胞酯酶（LEU）、蛋白（PRO）、亚硝酸盐（NIT）任一参数出现阳性；（2）方案2：单纯尿液有形成分仪器检测的RBC、WBC、管型（CAST）任一参数出现阳性；（3）方案3：联合干化学与有形成分分析仪检测的BLD、LEU与RBC、WBC结果不一致，或定量结果梯度相差2个或2个以上；（4）方案4：联合干化学与尿液有形成分分析仪BLD、LEU与RBC、WBC结果不一致，及CAST阳性或有报警提示出现，均进行复检。对4种复检规则方案分别进行评估，并选取400份尿液常规标本对该复检规则进行临床验证，评价其有效性。结果以显微镜检查结果为标准，用于建立复检规则的3154份尿液标本中，阳性标本占43.47％（1371/3154），阴性标本占56.53％（1783/3154）。其中RBC阳性标本占55.58％（762/1371）， WBC 阳性标本占59.66％（818/1371）， CAST 阳性标本占6.42％（88/1371）。制定的4种方案的复检率分别为44.48％（1403/3154）、45.69％（1441/3154）、26.09％（823/3154）、28.95％（913/3154），假阴率分别为7.13％（225/3154）、4.53％（143/3154）、2.73％（86/3154）、1.02％（32/3154）。方案4的假阴性率最低，复检率也较低，为理想的复检方案。选取400份尿液常规标本对其进行验证，其假阴性率为0.75％（3/400），复检率为26.25％（10Objective To establish the proper review rules for the microscopic screening of urine samples tested by automatic urinalysis work station.Methods A total of 3 154 random urine samples were enrolled to establish and validate review rules .All the samples were collected from the inpatients and outpatients of Shanghai First People′s Hospital from March to May 2013 and tested by urinalysis work station.Three thousands one hundred and fifty four urine samples were firstly tested by urinalysis work station,including both urine dry chemical analyzer and urine sediments analyzer .Then each urine sample was examined microscopically by two technicians-in-charge using double-blind method.The average results from the two technicians were used as review results .Compared with review results ,the review rules were set up.According to different test methods by automatic urinalysis work station , four microscopic review protocols were defined：（1）Protocol 1：based on chemistry results only ,microscopy review was performed when any of WBC,RBC,PRO and NIT was positive;（2）Protocol 2：based on urine sedimental analysis only ,microscopy review was performed when any of WBC ,RBC and CAST count was over upper limit of the reference range;（3）Protocol 3：if any of BLD ,RBC,LEU,WBC was different between two systems ,or quantitative results had two or more than two gradient differences ,microscopy review was performed;（4） Protoco1 4：if any of BLD, RBC,LEU ,WBC was different between two systems , or CAST was over upper limit of the reference range , or alarm appeared , microscopic review was performed .400 randomly selected urine samples were tested to validate the review rules .Omission diagnostic rate and review rate were used to evaluate the rules .Results According to the review rules,the positive samples rate was 43.47%（1 371/3 154） and the negative rate was 56.53%（ 1 783/3 154 ）;Positive samples were composed of RBC （ 55.58%） , WBC （ 59.66%） and CAST（6.42%）.The review rates of four protocols

关 键 词：尿分析 自动分析 显微镜检查 评价研究 

分 类 号：R446.12[医药卫生—诊断学]