中国医疗设备2018，Vol.33Issue(5)：93-96,4.DOI:10.3969/j.issn.1674-1633.2018.05.025
两台迈瑞BS380生化分析仪性能评价结果的比较分析
Comparison of Analytical Performances of Two Mindray 380 Auto Biochemistry Analyzers
摘要
Abstract
Objective The aim of this study was to compare analytical performances of two Mindray 380 auto biochemistry analyzers using matching reagents and to discuss analytical performances of domestic biochemistry analyzers and their quality control during application. Methods Durable years of the two analyzers were 0.2 year (BS380-1) and 3 years (BS380-2), respectively. Precision, methodological comparison, linearity and interference of 16 common tests and sample needle carryover effects were evaluated according to CLSI protocols EP5-A2, EP9-A2, EP6-A, EP7-A2 and China's pharmaceutical industry standard, respectively. Then results were compared between these two analyzers. Results Results of methodological comparison were not totally passed, though pass rates were not statistically significant (P=0.333). In addition, tests that were not passed were not the same; BS380-1's precision, linearity, interference and sample needle carryover effects all passed while BS380-2's did not perform well in the aspects of precision, interference and linearity. Results were as follows: Qualified rates of total precision was 78.1%, coincidence of proposed anti-interference was 83.8%, and linearity of TBIL was not as good as manufacturer's statement. Conclusion Domestic analyzer is suitable for its utilization in modern clinical laboratories. In order to realize results inter-accreditation, methodological comparison and accuracy transfer are needed even matching reagents are used. Also, periodic evaluation of analytical performances and real-time monitoring are awaited in order to guarantee effectiveness of results.关键词
生化分析仪/性能评价/国产设备/质量控制/结果互认Key words
biochemistry analyzer/evaluation of performance/domestic equipment/quality control/results inter-accreditation分类
医药卫生引用本文复制引用
徐含青,刘跃平,府伟灵,黄君富,魏昆,杨翔,黄庆..两台迈瑞BS380生化分析仪性能评价结果的比较分析[J].中国医疗设备,2018,33(5):93-96,4.基金项目
国家科技支撑计划课题(2013BAI17B04). （2013BAI17B04）
