建立尿有形成分参考区间方法学的比较研究

A comparative study on the reference interval establishment of urine cell count

目的比较分析离心法与不离心法尿沉渣显微镜检验的细胞学诊断效能,确定离心法的生物参考区间。方法对尿液标本分别使用离心法和不离心法定量计数每微升红细胞(RBC)、白细胞(WBC)、上皮细胞个数,对2种方法的细胞学诊断效能比较分析。根据尿液分析试纸条浸渍法分析结果,筛选蛋白(PRO)、RBC、WBC全阴性("-")的标本,制定离心法尿沉渣显微镜检验的生物参考区间。结果受试者工作特征(ROC)曲线下面积离心法RBC为0.652、不离心法RBC为0.663、离心法WBC为0.684、不离心法WBC为0.665;离心法上皮细胞、WBC与不离心法比较差异有统计学意义(P均<0.05);RBC 2种方法之间差异无统计学意义(P>0.05);女性上皮细胞、RBC、WBC第95百分位分别为23.0、2.4、4.1,男性分别为3.0、2.3、4.0。结论离心法尿沉渣检验并不能提高细胞学诊断阳性率,离心法与不离心法尿沉渣生物参考区间不能混用,鉴于尿液检验标准化推广和临床,应建立离心法生物参考区间。

Objective To compare the cytology diagnostic efficacy of urinary sediment by microscopy before and after centrifugation,and determine the biological reference interval of the centrifuged urine cell count method.Methods Urine specimens were examined by microscopy before and after centrifugation respectively,and the red blood cell（RBC） count（/μL）,white blood cell（WBC） count（/μL） and epithelial cell count（/μL） were recorded and compared the cytology diagnostic efficacies of the 2 methods.The normal urine specimens in which protein（PRO）,RBC and WBC were confirmed all negative by urine dipstick chemical analysis were used to determine the biological reference interval of the centrifuged urine cell count method.Results After receiver operating characteristic（ROC） curve analysis,the areas under the ROC curve of the 2 methods applied to RBC and WBC were 0.652 and 0.684 for centrifuged urine cell count method,and 0.663 and 0.665 for uncentrifuged urine cell count method.After paired test,there were significant differences between the 2 methods for epithelial cell and WBC（P0.05）,but the difference for RBC was not significant（P=0.111）.The 95% percentiles（/uL） of epithelial cell,RBC and WBC were 23.0,2.4 and 4.1 for female and 3.0,2.3 and 4.0 for male respectively.Conclusions The centrifuged urine cell count method cannot improve the diagnostic efficacy.The biological reference intervals cannot be mixed,and it is necessary to determine the biological reference interval of the centrifuged urine cell count method for its further spreading and clinical application.