SysmexUF5000尿沉渣分析仪的性能评价及与UF1000i共同检测566例尿液标本的准确性比对

Performance evaluation of sysmex UF5000 urine sediment analyzer and accuracy comparison with uf1000i in detecting 566 urine samples

目的评价SysmexUF5000尿沉渣分析仪的主要性能,并与UF1000i共同检测尿液标本进行准确性比对。方法根据ISO 15189认可的相关规定,以及厂家提供的验证方法,对UF5000精密度、携带污染率、线性范围、可报告范围的性能进行评价。并进一步选取566例尿液标本同时在SysmexUF5000和UF1000i尿沉渣分析仪上进行检测,以离心镜检的结果作为金标准,进行两台仪器检测尿液标本的假阳性率和假阴性率等准确性比对。结果SysmexUF5000尿沉渣分析仪的红细胞(RBC)、白细胞(WBC)、上皮细胞(EC)、管型(CAST)、细菌(BACT)的批内精密度、批间精密度均在厂家要求范围内,RBC、WBC、BACT的携带污染率、线性范围符合要求,可报告范围广。和UF1000i准确性比较,UF5000男、女性RBC假阳性率明显低于UF1000i,而男性CAST的假阳性率又高于UF1000i,差异具有统计学意义。UF5000内男性WBC的假阴性率明显低于女性,其他差异均无统计学意义。结论UF5000精密度高,携带污染率低,线性范围和可报告范围广,仪器的检测性能符合ISO 15189认可的需求。检测的准确性上,特别是RBC的检测较UF1000i有较大提升,通过联合尿干化学分析仪共同检测,建立合适的尿液复检规则,将可进一步降低UF5000的假阳性率和假阴性率。

Objective To evaluate the main performance of sysmex UF5000 urine sediment analyzer,and to compare the accuracy with uf1000i urine sample.Methods According to the relevant regulations approved by ISO 15189 and the verification method provided by the manufacturer,the performance of UF5000 precision,carrying pollution rate,linear range and reportable range are evaluated.Then 566 urine samples were tested on sysmex UF5000 and UF1000i urinary sediment analyzers at the same time.The results of centrifugal microscopy were used as the gold standard to compare the accuracy of false-positive rate and false-negative rate of two instruments.Results The intra batch precision and inter batch precision of RBC,WBC,EC,CAST and BACT of sysmex UF5000 urinary sediment analyzer are all within the requirements of the manufacturer,and the carrying pollution rate and linear range of RBC,WBC and BACT meet the requirements,with wide reportable range.Compared with the accuracy of UF1000i,the false-positive rate of RBC of male and female UF5000 was significantly lower,while the false-positive rate of male cast was higher,the difference was statistically significant.The false negative rate of WBC in male within UF5000 was significantly lower than that in female,other differences were not statistically significant.Conclusion Uf5000 has high precision,low carrying pollution rate,wide linear range and reportable range,and its detection performance meets the requirements approved by ISO 15189.The accuracy of detection,especially RBC detection,is greatly improved compared withUF1000i.The false positive rate and false negative rate of UF5000 can be further reduced by combining with urine dry chemical analyzer to establish appropriate urine recheck rules.