尿沉渣分析仪与显微镜检测尿液有形成分的比较分析

Comparative Analysis of Urine Sediment Automatic Analyzer and Microscope for Detecting Urine Formation

目的:通过比较尿沉渣分析仪与显微镜镜检对尿液中有形成分的检查结果,验证和评价尿沉渣分析仪的性能。方法:选取208例尿液标本进行尿干化学检测、尿沉渣检测,并进行显微镜验证,比较二者检测结果的假阴性率、假阳性率以及符合率,并对尿沉渣分析仪的精密度、携带污染率、准确性和线性范围四大性能指标进行验证和评价。结果:尿沉渣分析仪检测白细胞的假阴性率为3.92%(2/51),假阳性率为4.46%(7/157),检出符合率为95.67%;检测红细胞的假阴性率为9.09%(4/44),假阳性率为4.27%(7/164),检出符合率为94.71%;检测管型的假阴性率为16.67%(3/18),假阳性率为0.53%(1/190),检出符合率为98.08%。高值、低值2个水平的红细胞批间精密度分别为6.3%、6.8%;批内精密度分别为5.4%和6.9%,均≤12%,红细胞携带污染率为0≤0.05%;红细胞检测平均准确率达100.9%,平均误差率为-0.9%;红细胞检测线性范围为与试剂盒线性范围相符,线性方程相关系数R2>0.95,线性良好。结论:尿沉渣分析仪检测红细胞项目的精密度、携带污染率、准确度和线性范围均达到相关标准要求,检测结果与人工显微镜镜检结果符合率高,误诊率和漏诊率较低,具有临床可操作性和有效性。

Objective:To vertify and evaluate the performance of the urine sediment automatic analyzer by comparing the urinary sediment analyzer with microscopic examination for the results of formation of urine. Methods: A total of 208 urine samples were detected by AVE-766 urinary sediment analyzer, Urine dry chemical analyzer, Olympus microscopic examination, and the results of the false positive rate and the false negative rate of RBC, WBC, and CAST were compared. The AVE-766 was evaluated by measurement of precision, carry over, accuracy and linearity. Results: With AVE-766, the WBC’s false negative rate was 3.92% and the false positive rate was 4.46%, the coincidence rate between AVE-766 and the microscopic examination was 95.67%;RBC’s false negative rate was 9.09% and the false positive rate was 4.27%, the coincidence rate between AVE-766 and the microscopic examination was 94.71%;CAST’s false negative rate was 16.67% and the false positive rate was 0.53%, the coincidence rate between AVE-766 and the microscopic examination was 98.08%. The high and low values of RBC of inter-assay precision were 6.3% and 6.8% respectively less than or equal to 12%. The high and low values of RBC of intra-assay precision were 5.4% and 6.9% respectively less than or equal to 12%. The carry over rates of RBC were 0, which was less than or equal to 0.05%. The average accuracy of RBC detection is 100.9% and the mean error rate is -0.9%. The linear range of red blood cell detection was in consistent with the linear range of the kit, and the linear equation correlation coefficient R2 was more than 0.95. Conclusion: The urinary sediment analyzer we used meets the required standards of precision, carrying pollution rate, accuracy and linear range of the red blood cell project. The test results are in good agreement with the results of manual microscopy, and the misdiagnosis rate and missed diagnosis rate are low. Therefore, it has clinical operability and effectiveness.