Comparison of Analytical Performances of Two Mindray 380 Auto Biochemistry Analyzers
XU Hanqing1, LIU Yueping1,2, FU Weiling1, HUANG Junfu1, WEI Kun1, YANG Xiang1, HUANG Qing1
1.Department of Laboratory Medicine, The First Affiliated Hospital of Army Medical University, Chongqing 400038, China;
2.Department of Laboratory Medicine, 477 Hospital of PLA, Xiangyang Hubei 441003, China
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.
徐含青1，刘跃平1,2，府伟灵1，黄君富1，魏昆1，杨翔1，黄庆1. 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.
XU Hanqing1, LIU Yueping1,2, FU Weiling1, HUANG Junfu1, WEI Kun1, YANG Xiang1, HUANG Qing1. Comparison of Analytical Performances of Two Mindray 380 Auto Biochemistry Analyzers. China Medical Devices, 2018, 33(5): 93-96.
