CAJ | 학술논문

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。
목적：대룡흠LX-8000전자동뇨액분석의（일체궤）뇨액유형성분、검측성능진행평개，병대검측결과적가신도진행험증。방법근거《뇨액유형성분분석의표준》적요구，선취림상451빈뇨액표본，집행7개삼수적성능평개：검출한、중복성、식별솔、은정성、휴대오염솔、선성회귀분석、가보고선성범위。결과 LX-8000대홍세포（RBC ）농도5개／미승적양품검출솔위90％；중복성：대RBC농도50개／미승적양품진행검측기변이계수（CV ）위24％，대200개／미승적양품진행검측기 CV위11％；식별솔：대RBC、백세포（WBC ）、관형적검측기부합솔분별위82．4％、80％、10．5％；가음성솔위4％；은정성：개궤8 h내，대RBC （농도200개／미승）진행중복성측정기 CV＜15％；RBC、WBC휴대오염솔분별위0．015％、0．026％；RBC、WBC상관계수（ r2）분별위0．9988、0．9989；가보고선성범위위2～15000개／미승。결론 LX-8000뇨액분석의재뇨액유형성분검측중성능량호，주요지표검측적결과부합행업표준，가용우림상뇨액분석적초사，단필요시수진행인공경검복핵，이보증검측결과적준학성。
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 .