UriSed尿沉渣分析仪的临床应用评估

Clinical evaluation of UriSed urine sediments analyzer

目的对UriSed尿沉渣分析仪的临床应用进行评估。方法随机收集患者新鲜中段尿液标本,使用UriSed尿沉渣分析仪对尿液有形成分进行分析,评价分析仪的图像合格率、标记率、标记正确率、重复性、线性、互染率,并比较其与UF500尿沉渣分析仪对低值细胞的检出符合率。结果图像合格率为98.23%。有形成分标记率为:病理管型(100%)、白细胞(82.5%)、红细胞(74.7%)、小圆上皮细胞(73.6%)、上皮细胞(64.1%)、真菌(54.1%)。有形成分的标记正确率为:小圆上皮细胞(100%)、白细胞(99.9%)、上皮细胞(99.5%)、真菌(98.1%)、红细胞(97.4%)、病理管型(1.5%)。高、中、低水平白细胞尿标本的变异系数依次为:4.68%、3.45%、4.48%。分析仪对低值白细胞的具有良好的线性关系,但对低值红细胞的检测线性欠佳。测定白细胞的互染率为0。UriSed与UF500对100/L白细胞的检出符合率为97.4%,对100/L红细胞的检出符合率为96.8%。结论除对低值红细胞检测的线性关系不佳之外,UriSed尿沉渣分析仪主要指标能满足临床应用要求。

Objective To evaluate the clinical application functions and effects of UriSed urine sediments analyzer. Methods Fresh mid stream urine specimens were randomly collected and the formed elements were analyzed using UriSed urine sediments an- alyzer. The qualification rate of images,marking rate and rate of correct marking of major formed elements,repeatability,linearity, mutual infection rate were tested. The coincidence of positive rate was analyzed between UriSed and UF500 urine sediments analyzer when they were used to measure low-valued RBC or WBC samples. Results The qualification rate of images was 98. 23%. The marking rates of the formed elements were as follow ： pathological casts （ 100 % ）, WBCs （82.5 % ）, RBCs （74.7 % ）, small round epi- thelial cells（73.6 % ）, epithelial cells（64.1 % ）, fungi（54.1 G）. The rates of correct marking of the formed elements were as follow： small round epithelial cells （ 100 % ）, WBCs （ 99. 9 % ）, epithelial cells （ 99. 5 % ）, fungi （ 98. 1% ）, RBCs （ 97.4 % ）, pathological casts （1.5%）. The coefficient of variation of WBCs for high,intermediate and low concentration were 4.68%,3.45% and 4.48% ,re- spectively. A good linearity was found between the detected value and theoretical value when detcting specimen with low-valued WBCs, but a poor linearity instead when deteting specimen with low-valued RBCs. The carry-over rate when detecting WBCs was 0. The coincidence of positive rate between UriSed and UF500 urine sediments analyzer were 97.4% and 96.8 % respectively, when low-valued WBC and RBC samples less than 100/L were measured. Conclusion UriSed urine sediments analyzer meets the basic clinical requirements as a diagnostic equipment,except that the linearity was poor when detcting specimen with low-valued RBCs.