Modern Scientific Instruments 现代科学仪器N o.6 D e c. 2019第6期2019年12月
·119·应用YY/T0654-2017国家标准评价某国产全自动生化分析仪 农业产业化
周怡成
金宏柱
（四川省中西医结合医院 医疗装备部 四川成都 610041）
摘 要 目的：应用YY/T0654-2017国家标准对本院新购的全自动生化分析仪（XC8001）性能进行评价。方法：按照YY/T0654-2017国家标准的有关规定对XC8001生化仪进行性能评价，指标包括：杂散光，吸光度（Abs）的线性范围、准确度、稳定性和重复性，温度准确度与波动值，样品携带污染率（SCCR），加样准确度与重复性，以及丙氨酸氨基转移酶（ALT）、尿素（Urea）和总蛋白（TP）临床项目的批内精密度。结果：该仪器杂散光检测吸光度值为6.1102，吸光度线性范围为0.0005～3.5905，第5～11点的相对偏倚分别为-0.71%、0.29%、0.97%、-0.02%、0.81%、0.60%和1.04%，最大吸光度为3.5905。吸光度准确度的算术平均值与标准值之差分别为0.0020和-0.0114，吸光度稳定性在340nm，吸光度变化值为0.0071，660nm 吸光度变化值为0.0054，吸光度重复性CV 值为0.93%。温度准确度为0.1℃，温度波动值为0.1℃。该仪器的SCCR 仅为0.01%，样本针、试剂针1和试剂针2的加样准确度分别为1.08%、0.42%和0.35%，重复性分别为0.98%、0.65%和0.72%。临床项目ALT、Urea 和TP 的批内精密度分别为1.93%、0.89%和0.24%。结论：XC8001生化仪的各项检测指标均符合YY/T065 4-2017国家标准的规定要求，可将该检测系统应用于本实验室的常规检测，为本院临床诊断提供准确可靠的检测结果。
关键词 全自动生化分析仪；国家标准；样品携带污染率；吸光度；性能评价
中图分类号 R446,R197.39 文献标识码 A
Evaluation of a domestic automatic biochemical analyzer by YY/T0654-2017 national
小数定律
棉纺手册standard
Zhou Yicheng地源热泵设计
（The equipment section of the Sinchuan integratibe medicine hospital, Chengdu 610041, China ）
Abstract objective: The performance of t he newly purchased automatic biochemical analyzer (XC8001) was evaluated using the YY/T0654-2017 national standard.Methods:To evaluate the performance of the XC8001 biochemical instrument in accordance with the relevant provisions of the YY/T0654-2017 national standard, Indicators include: the linear range, accuracy, stability and repeatability of absorbance (Abs), Temperature accuracy and volatility, and the contamination rate (S诺基亚8800黄金版
CCR), of samples are carried out. The accuracy and reproducibility of addition and the intra-assay precision of alanine aminotransferase (ALT), urea (Urea) and total protein (TP) clinical items. Results: The optical absorption value of the instrument for stray light detection is 6.1102, The linear range of absorbance was 0.0005~3.5905, the Di of 5~11 was-0.71%, 0.29%, 0.97%, 0.02%, 0.81%, 0.60% and 1.04%, respectively. The maximum absorbance was 3.5905. The difference between the arithmetic mean of absorbance accuracy and the standard value is 0.0020 and -0.0114, respectively. Absorbance stability at 340nm absorbance change value is 0.0071, 660nm absorbance change value is 0.0054, The CV of absorbance repeatability was 0.93%. The temperature accuracy is 0.1℃ and the temperature fluctuation is 0.1℃. The SCCR of the instrument is only 0.01%. The accuracy of sample needle, reagent needle 1 and reagent needle 2 is 1.08%, 0.42% and 0.35%, respectively. The repeatability is 0.98%, 0.65% and 0.72% respectively. The intra-assay precision of ALT, Urea and TP were respectively 1.93%, 0.89% and 0.24%. Conclusion: The testing indexes of XC8001 biochemistry instrument all meet the requirements of YY/T0654-2017 national standard. The detection system can be applied to the routine detection in our laboratory and provide accurate and reliable detection results for clinical diagnosis in our hospital.
Key words automatic biochemical analyzer; national standards; sample carrying contamination rate; absorbance; performance assessment
收稿日期：2019-10-02
作者简介：周怡成（1981.08-），男，四川德阳人，本科，中级讲师，研究方向：设备管理方面的研究。
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