科宝XS全自动尿液有形成分分析仪的性能评价

Performance evaluation and clinical application of COBIO XS automatic urinary sediment analyzer

目的：为了保证临床尿液有形成分分析的质量,对科宝XS全自动尿液有形成分分析仪进行性能评价。方法：根据《尿液有形成分分析仪标准》的要求,选取临床770份尿液标本,对批内精密度、仪器的自动混匀能力、稳定性、检出限、携带污染率、不同留尿量检测评估、相关系数、ROC曲线下AUC值、临床可报告范围等进行性能评价。结果：对于浓度为50和200个/μl的标本,红细胞的变异系数（coefficient of variation,CV）分别为14.44%和8.93%,白细胞的CV分别为15.74%和13.48%;即刻、放置1 h、放置2 h的尿液与放置1 h、放置2 h后加人工辅助混匀的尿液中的红细胞、白细胞的计数结果差异无统计学意义（P〉0.05）;浓度为300个/μl的红细胞标本溶液开机预热后即刻、开机预热后4 h、开机预热后8 h检测结果的CV〈15%;浓度为5个/μl的红细胞、白细胞尿液标本的检出限均为100%;红细胞、白细胞的携带污染率均为0%;同一份标本分成3、6、8、10 ml后上机检测,各管的红细胞、白细胞计数结果差异无统计学意义;红细胞、白细胞的相关系数分别为0.922 2和0.903 6,ROC曲线下AUC值分别为0.918和0.934,可报告线性范围分别为0-140 800和0-44 800个/μl。结论：科宝XS全自动尿液有形成分分析仪性能优良,结果符合行业标准,可用于临床尿液沉渣分析。

Objective To evaluate the performance of COBIO XS urine sediment analyzer for the detection of RBC and WBC.Methods Upon the requirements of Standard of Urine Tangible Composition Analyzer, a total of 770 urine specimens were collected for performance evaluation in terms of within-run precision, stability, residual contamination rate, the best cut-off values, sensitivity and specificity in the detection of RBC and WBC, evaluation of test results from urine samples of different volume and its clinical report range. Results At the concentration of 50 and 200/μl, the coefficients of variability（CV） for the detection of RBC were 14.44% and 8.93% respectively, and the CVs for detection of WBC were 15.74% and 13.48%respectively. There were no statistical differences between the results of RBC and WBC counts of fresh urine, the urine after 1 hour standing, the urine after 2 hour standing, the urine blent after 1 hour standing and the urine blent after 2 hour standing（P 0.05）. For the urine with the concentration being 300 per μl, the CV values acquired after preheating, 4 hour after preheating and 8 hour preheating were all less than 15%. For the urine with the concentration being 5 per μl, the detection limits of RBC and WBC were both 100%. The residual contamination rates of red and white blood cells were both 0%. The same samples were divided into 3, 6, 8, 10 ml and each sample was detected on the instrument, there was no significant difference in red blood cells number and white blood cells number. The correlation coefficients of RBC and WBC were 0.922 2 and 0.903 6 respectively. The areas under the curve for the detection of red and white blood cells were 0.918 and 0.934,respectively. The linear report ranges of red and white blood cells were from 0 to 140 800 and from 0 to 44 800/μl respectively.Conclusion The performance of COBIO XS automatic urine sediment analyzer in the detection of red and white blood cells is favorable, with the test results of the main indexes comparable to the industrial standards. The analyzer thus can reliably be put into clinical use.