IQ200尿有形成分分析仪性能评估

目的对IQ200尿有形成分分析仪的性能进行验证,并将该仪器和人工显微镜镜检法结果比对。方法共收集250份新鲜尿液标本,分别采用人工显微镜镜检法和IQ200尿有形成分分析仪进行检测。评估该仪器检测尿有形成分的批内精密度、批间精密度、携带污染率、线性范围等性能指标,并对仪器与人工显微镜镜检法计数结果的相关性和一致性进行评价,利用受试者工作特征曲线(ROC曲线)计算各项参数的灵敏度、特异度及准确度。结果IQ200尿有形成分分析仪检测标本的批内精密度、批间精密度、线性范围以及携带污染率等性能指标满足厂家声明的要求。IQ200尿有形成分分析仪与人工显微镜镜检法检测红细胞(RBC)、白细胞(WBC)、上皮细胞(SQEP)结果的相关系数分别为0.945、0.949、0.950。仪器检测RBC、WBC、SQEP的灵敏度较高,管型(CAST)、真菌(YST)、结晶(CRY)的灵敏度较低;所有项目的特异度均较好,但检测WBC、SQEP、CRY的特异度高于RBC、CAST、YST;检测RBC、WBC、SQEP的准确度均高于90%,其ROC曲线下面积分别是0.947、0.974、0.980。结论IQ200尿有形成分分析仪的性能验证结果符合质量要求,对RBC、WBC、SQEP的诊断性能优于CAST、YST、CRY,可用于临床尿液标本初筛,但仍然要与人工显微镜镜检相结合以确保结果的准确性。

Performance evaluation of IQ200 urine sediment analyzer

Objective To evaluate the analytic performance of IQ200 urine sediment analyzer,and to compare results those from manual microscopic examination.Methods A total of 250 fresh urine samples were collected and tested by manual microscopic examination and IQ200 respectively.The intra-precision,inter-precision,carrying contamination rate,linear range and other performance indexes detected by the instrument method were evaluated,and the correlation and consistency of the counting results of the instrument method and the manual microscopic examination were evaluated,and the sensitivity,specificity and accuracy of various parameters were calculated by ROC curve.Results Within intra-precision,intra-precision,linear range and carryover of IQ200 all met the requirement of manufactory.Correlation coefficients of red blood cell(RBC),white blood cell(WBC)and squamous epithelial cell(SQEP)detected by IQ200 were 0.945,0.949 and 0.950 respectively.The sensitivity of RBC,WBC and SQEP was higher than that of CAST,yeast like fungi(YST)and crystallization(CRY).The specificity of WBC,SQEP and CRY was better than that of RBC,CAST and YST.The accuracy of RBC,WBC and SQEP were all more than 90%,and their AUC were 0.947,0.974 and 0.980 respectively.Conclusion The performance verification results of IQ200 meet the quality requirements,the performance of detecting RBC,WBC and SQEP are better than CAST,YST and CRY.But it still needs to be combined with manual microscopic examination to ensure the accuracy of the results.