基于全景数字图像法的Cobas u701尿液有形成分分析仪在尿液标本检测中的运用评价

Application of Cobas u701 urinary sediment analyzer based on panoramic digital image method in detection of urine specimen

目的评价Cobasu701尿液有形成分分析仪是否能运用于临床尿液标本检验。方法参照中华人民共和国医药行业标准(YY/T0996—2015),从识别率、精密度、携带污染率、线性范围等几方面进行评价。结果各项目结果均符合行业判断标准。Cobasu701红细胞、白细胞和管型的镜检符合率依次为88.9%、88.3%、85.1%,假阴性率依次为1.8%、2.5%和2.9%,敏感度依次为86.7%、90.0%和88.3%,特异度依次为98.0%、91.2%和37.5%。携带污染率为0,红细胞线性a=1.006,r=0.997,白细胞线性a=1.009,r=0.998。结论通过4个方面评估基于全景数字图像法的Cobasu701尿液有形成分分析仪,所有项目结果均符合YY/T0996—2015要求,可运用于临床尿液标本检测。

Objective To evaluate whether the Cobas u701 urine fractionation analyzer can be used in the detection of clinical urine specimens. Methods According to the People’s Republic of China Pharmaceutical Industry Standard ( YY /T 0996- 2015), the evaluation was conducted in recognition rate, precision, carrying pollution rate, and linear range. Results The results of each project were in line with industry standards. The coincidence rates of red blood cells, white blood cells, and casts of Cobas u701 were 88. 9%, 88. 3%, and 85. 1%, respectively. The false negative rates were 1. 8%, 2. 5%, and 2. 9%, and the sensitivity was 86. 7%, 90. 0%, and 88. 3%, respectively. The specificity was 98. 0%, 91. 2%, and 37. 5%, respectively. The contamination - carrying rate was 0, the red blood cell linearity was a = 1. 006, r = 0. 997, and the white blood cell linearity was a = 1. 009, r = 0. 998. Conclusion The Cobas u701 urine fractionation analyzer based on the panoramic digital image method was evaluated in four aspects. The results of all the items were in line with YY /T 0996-2015 requirements and could be applied to the detection of clinical urine specimens.