迪瑞FUS-2000全自动尿液分析仪检测尿液红细胞、白细胞的性能评价

摘要

Objective To validate the performance parameters of DIRUI FUS-2000 automated urine analyzer declared by the manufacturer.Methods The fresh urine samples were diluted with special diluent to different concentration of suspension according to experimental requirements,then such parameters were validated as the precision,carrying pollution rate,detection limit and reportable range.At the same time,the coincidence rate of red blood cells and white blood cells was also verified in urine samples tested by FUS-2000 according to the result of manual inspection.Results RBC had the low and median values for within-run precision being 7.74％ and 6.13％ respectively,and WBC had the low and median values for within-run precision being 14.35％ and 2.45％ respectively.The negative and positive quality control materials had the between-run precision being 0％ and 3.43％ respectively.The carrying pollution rate was 0.08％ for RBC and 0.57％ for WBC,and the detection limits for RBC and WBC were both 10 ones per Liter.The reportable range was from 10 to 38 754 p/μl for RBC and from 10 to 32 202 p/μl for WBC.The coincidence rate with artificial microscopy was 90.83％ for RBC and 95.83％ for WBC.Conclusion FUS-2000's performance parameters are in line with the requirement,and it can be used for the clinical urine detection.The review criteria of FUS-2000 should be established to improve distinguishing sensitivity and specificity of RBC and WBC in urine.%目的:验证迪瑞FUS-2000全自动尿液分析仪的性能参数与厂商宣称值的一致性.方法:利用来自临床的新鲜尿液标本,通过专用标本稀释液按实验要求配制成一定浓度的悬液,进行精密度、携带污染率、检出限、可报告范围的验证,同时结合人工镜检对FUS-2000全自动尿液分析仪检测尿液标本中的红细胞、白细胞的符合率进行验证.结果:批内精密度:红细胞低值与中值分别为7.74％、6.13％,白细胞低值与中值分别为14.35％、2.45％;批间精密度:阴性质控品0％,阳性质控品3.43％;携带污染率:红细胞0.08％,白细胞0.57％;检出限:红细胞、白细胞均为10个/μl;可报告范围:红细胞10～38 754个/μl,WBC 10～32 202个/l.与人工镜检相比较,红细胞符合率为90.83％,白细胞符合率为95.83％.结论:FUS-2000全自动尿液分析仪各项性能指标基本符合要求,可应用于临床尿液标本检测.但需使用合适的复检规则,结合尿液干化学试验及人工镜检的结果,提高尿液中红细胞、白细胞识别的敏感性和特异性.