目的：对龙鑫LX-8000全自动尿液分析仪（一体机）尿液有形成分、检测性能进行评价，并对检测结果的可信度进行验证。方法根据《尿液有形成分分析仪标准》的要求，选取临床451份尿液标本，执行7个参数的性能评价：检出限、重复性、识别率、稳定性、携带污染率、线性回归分析、可报告线性范围。结果 LX-8000对红细胞（RBC ）浓度5个／微升的样品检出率为90％；重复性：对RBC浓度50个／微升的样品进行检测其变异系数（CV ）为24％，对200个／微升的样品进行检测其 CV为11％；识别率：对RBC、白细胞（WBC ）、管型的检测其符合率分别为82．4％、80％、10．5％；假阴性率为4％；稳定性：开机8 h内，对RBC （浓度200个／微升）进行重复性测定其 CV＜15％；RBC、WBC携带污染率分别为0．015％、0．026％；RBC、WBC相关系数（ r2）分别为0．9988、0．9989；可报告线性范围为2～15000个／微升。结论 LX-8000尿液分析仪在尿液有形成分检测中性能良好，主要指标检测的结果符合行业标准，可用于临床尿液分析的初筛，但必要时需进行人工镜检复核，以保证检测结果的准确性。%Objective To evaluate the detection performances of LX-8000 automated urine analyzer (LX-8000 analyzer) for detecting urinary formed elements .Methods A total of 451 urine specimens were collected and detected according to the requirement of the Standard of Urine Tangible Composition Analyzer ,and 7 parameters of perform-ance evaluation ,including detection limit ,repeatability ,recognition rate ,stability ,residual contamination rate ,linear regression and the linear range of reports were analyzed .Results For the detection of red blood cells with a concen-tration of 5/μL ,the detection rate was 90% .The coefficient of variability for the detection of red blood cells with con-centration of 50/μL and 200/μL were 24% and 11% respectively .The compliance rates for red blood cells ,white blood cells and casts were 82 .4% ,80 .0% and 10 .5% respectively The false negative rate was 4% .The coefficient of variability for the detection of red blood cell (concentration of 200/μL) was less than 15% within 8 h since boot op-eration .The residual contamination rates of red blood cell and white blood cell were 0 .015% and 0 .026% respective-ly .Linear correlation coefficients (r2 ) of red blood cell and white blood cell were 0 .998 8 and 0 .998 9 .The linear range of report was 2-15000/μL .Conclusion LX-8000 analyzer might be applicable for the screening of clinical urine analysis with fine performance in detecting urinary formed elements ,and the test results of the main indexes could be accord with industry standards .But artificial microscopy review might be performed ,when being needed ,to ensure the accuracy of test results .
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