干化学与流式细胞联合尿液分析复检标准的制定与应用

目的 制定适合本实验室的尿液自动化分析（AX-4280尿干化学分析仪结合UF-1000i尿有形成分分析仪）复检规则.方法 随机收集卫生部北京医院2010年12月至2011年12月尿液常规标本4 049份.每份标本经流水线自动化检测后,由2名经验丰富的检验师以双盲法进行尿沉渣显微镜检,以2人检测结果的均值作为镜检结果.利用流水线配套的UriAccess 3.0软件对4 049份标本自动化检测和显微镜检的结果进行分析,分析项目包括干化学检测得到的尿潜血、尿白细胞和尿蛋白结果,有形成分分析和显微镜检得到的RBC、WBC和管型结果,以显微镜检结果为金标准,计算不同规则组合下的真阳性率、假阳性率、真阴性率、漏诊率（假阴性率）和复检率,初步确定本实验室的复检规则.随后选取189例尿液标本对该规则进行有效性验证,综合假阴性率和复检率来评价该规则的可行性.结果 最终筛选出需要复检的规则47条,该规则的真阳性率为32.38%（1 311/4 049）、假阳性率为22.33%（904/4 049）、真阴性率为43.12%（1 746/4 049）、假阴性率为2.17%（88/4 049）、镜检率为27.76% （1 124/4 049）.利用189例尿液标本对本规则验证得到的假阴性率为1.06%（2/189）,镜检率为26.46%（50/189）.2例漏诊标本来自肾内科门诊和中医科,镜检RBC为4/HP,WBC为7/HP,对严重肾脏病患者不会造成漏诊.结论 本复检规则可有效筛选出临床需要显微镜复检的尿常规标本,无严重漏诊发生,复检率适中,适用于本实验室尿液自动分析复检.

Development and application of microscopy review criteria of urinalysis combination of dry chemistry and flow cytometry

Objective To establish the review criteria of urinalysis combination of AX~4280 urine dry chemeical analyzer and UF-1000i urine particle analyzer at our laboratory. Methods A total of 4 049 samples were collected randomly from Beijing Hospital of Ministry of Health from December 2010 to December 2011. After analysis on automated analysis line, each sample was examined by two experienced technicians with double-blind method. Their mean results were regarded as the microscopic examination results. The automatic detection and microscopy results of 4 049 samples were analyzed by the UriAccess 3.0 software. The results included BLD LEU and PRO of AX4280, RBC WBC and CAST of UF-1000i and microscopic examination. The mieroscopy results were set as the gold standard. And the values of true positive rate, false positive rate, true negative rate, false negative rate and review rate of different combinations of rules were calculated. Then 189 urine samples were examined to validate the feasibility of rules by false negative rate and review rate. Results After analysis, 47 rules were selected for microscopic review. The true positive rate of this review criteria was 32.38% （1 311/4 049）, false positive rate 22. 33% （904/4 049）, true negative rate 43. 12% （ 1 746/4 049）, false negative rate 2. 17% （88/4 049） and review rate 27.76% （ 1 124/4 049）. The false negative rate of this review criteria was 1.06% （2/189） and review rate 26. 46% （50/189）. Two eases of missed diagnosis specimens came from renal outpatient depamnent of internal medicine and department of traditional Chinese medicine, the mieroscopie results of RBC and WBC were 4/HP and 7/HP respectively. So this criteria would not cause a missed diagnosis for patients with severe kidney disease. Conclusions This review criteria can effectively screen the urine samples to diagnose patients with severe kidney disease. So this review criteria is suitable for the screening of urinalysis results at our laboratory.