西门子Atellica®UAS800尿沉渣分析仪性能验证  

Performance Verification of Siemens Atellica®UAS800 Urinary Sediment Analyzer

作　　者：杨韩燕 欧财文[2] 郑智明[2] 吴新忠[2] YANG Han-yan;OU Cai-wen;ZHENG Zhi-ming;WU Xin-zhong(Department of Laboratory Medicine,Yulin Hospital of Traditional Chinese Medicine,Guangxi Yulin 537000;Department of Laboratory Medicine,Guangdong Hospital of Traditional Chinese Medicine,Guangdong Guangzhou 510000)

机构地区：[1]玉林市中医医院检验科,广西玉林537000 [2]广东省中医院检验科,广东广州510000

出　　处：《中国医疗器械信息》2021年第9期41-44,共4页China Medical Device Information

摘　　要：目的:验证西门子Atellica®UAS800尿沉渣分析仪质量性能,以期对医学实验室尿沉渣分析仪的性能评估提供参考。方法:按中华人民共和国相关医药行业标准的要求,对Atellica®UAS800尿沉渣分析仪的红细胞和白细胞进行检测,判断其重复性、批间精密度、检出限、稳定性、携带污染率、线性范围。同时以显微镜检测结果为金标准,计算Atellica®UAS800检测红细胞、白细胞、管型的识别率和假阴性率。结果:Atellica®UAS800对红细胞、白细胞、管型的识别率分别为85.3%、86.7%、85.3%,假阴性率分别为0.43%、1.29%、2.79%,其余各项验证项目也均符合行业标准要求。结论:Atellica®UAS800各项性能达到行业标准要求,操作简单,自动化程度高,具有较高的临床应用价值。Objective:To verify the performance of the Atellica®UAS 800 Urine Sediment Analyzer,to provide a reference for the performance evaluation of urine sediment analysis systems in the medical laboratory.Methods:According to the requirements of relevant pharmaceutical industry standards of the people’s Republic of China,red and white blood cells were tested on the Atellica®UAS 800 sediment analyzer to determine repeatability,precision,detection limit,stability,carryover,linearity.Additionally,using manual microscopic test results as the gold standard,the recognition rate and false-negative rate for red blood cells,white blood cells,and casts detected by the Atellica®UAS 800 analyzer were calculated.Results:The identification rate for red blood cells,white blood cells,and casts on the Atellica®UAS 800 system was 85.3%,86.7%,and 85.3%,respectively,and the false-negative rate was 0.43%,1.29%,and 2.79%,respectively.The other verification items also met the industry standards.Conclusion:The Atellica®UAS 800 meets the requirements of industry standards and provides simple operation,a high level of automation,and high clinical application values.

关 键 词：尿沉渣 性能验证 行业标准 符合率 

分 类 号：TH776[机械工程—仪器科学与技术]