Central Laboratory, Quanzhou First Hospital A!liated to Fujian Medical University, Quanzhou, Fujian, China.
Department of Clinical Laboratory Medicine, Xijing Hospital, Fourth Military Medical University (Air Force Medical University), Xi'an, Shaanxi, China.
Ann Clin Lab Sci. 2021 Jul;51(4):562-569.
The aim of this study was to evaluate the consistency and accuracy of all the parameters of the urine samples detected by two automated urine sediment analyzers from Sysmex Corporation.
Two automated analyzers and manual microscopy examined 1,059 urine samples. The sensitivity, specificity, positive predictive value, and negative predictive value were evaluated. The consistency of all the parameters was tested. The influencing factors of false positive and false negative samples were analyzed and compared.
All the parameters had good specificity, negative predictive value, and coincidence rate (83.95%-99.61%). The RBC, WBC, and X'TAL analyzed by UF-5000 and UF-1000i exhibited good agreement (Kappa=0.597-0.784) with those by manual microscopy. The overall concordance rates of RBC and WBC were good (RBC: r=0.9842, CCC=0.9693; WBC: r=0.9955, CCC=0.9711). Among the influencing factors, mucus filament accounted for a large proportion, which mainly affected the detection of CAST. Concurrently, the false-positive factors of EC detection were reduced, and CAST did not affect the detection of EC.
The parameters of the two instruments tested have shown high accuracy, consistency, coincidence rate, and low negative predictive value for RBC and WBC, which has ensured that UF-5000 and UF-1000i meet the clinical requirements for urine tests for disease screening. For the samples with poor consistency and false-positive factors, a conventional microscopic examination should be applied to verify the accuracy of the instrument detection.
本研究旨在评估两台来自希森美康公司的自动化尿液沉渣分析仪检测的所有尿液样本参数的一致性和准确性。
两台自动化分析仪和人工显微镜检查了 1059 份尿液样本。评估了灵敏度、特异性、阳性预测值和阴性预测值。测试了所有参数的一致性。分析并比较了假阳性和假阴性样本的影响因素。
所有参数均具有良好的特异性、阴性预测值和符合率（83.95%-99.61%）。UF-5000 和 UF-1000i 分析的 RBC、WBC 和 X’TAL 与人工显微镜检查具有良好的一致性（Kappa=0.597-0.784）。RBC 和 WBC 的总一致性率良好（RBC：r=0.9842，CCC=0.9693；WBC：r=0.9955，CCC=0.9711）。在影响因素中，黏液丝占比较大，主要影响 CAST 的检测。同时，减少了 EC 检测的假阳性因素，而 CAST 不影响 EC 的检测。
两台仪器检测的参数在 RBC 和 WBC 方面具有较高的准确性、一致性、符合率和较低的阴性预测值，这确保了 UF-5000 和 UF-1000i 满足疾病筛查的临床尿液检测要求。对于一致性差和存在假阳性因素的样本，应应用常规显微镜检查来验证仪器检测的准确性。
