Performance Qualification of DH71CRP Hematology Analyzer for CRP
LIU Lingling1, SU Yafei2, ZHANG Le1, CHEN Dongzhe1, WANG Zhaobao1,XING Fanglin1, YANG Lin1, LIU Licun1, SUN Wenwen1
1. Department of Clinical Laboratory Medicine, Affiliated Shandong Provincial Hospital, Shandong University, Jinan Shandong
250021, China; 2. School of Medical Information Engineering, Jining Medical College, Rizhao Shandong 276826, China
Abstract：Objective To verify and evaluate the performance of DH71CRP hematology analyzer for C-reactive protein (CRP)
detection in whole blood using immunoturbidimetry. Methods According to the requirements of industry standards, the performance
parameters (precision, contamination rate, accuracy, linearity, and inter-instrument comparison) of DH71CRP for whole blood CRP
detection using immunoturbidimetry were verified and evaluated. The CRP result from DH71CRP was compared with that from
Pentra MSCRP blood analyzer and AU5800 automatic biochemical analyzer. Results Whole blood CRP detection by DH71CRP
analyzer using immunoturbidimetry showed good precision (within-run: lower value CV 3.06%, higher value CV
2.53%, inter-run: lower value CV3.97%, higher value CV3.75%), low contamination rate (0.22%), and high accuracy
compared with Pentra MSCRP and AU5800. Although the linear range did not reach the manufacturer's declaration,
the linear range was wide (0.2~210 mg/L), making the result reliable. Conclusion Whole blood CRP detection by
DH71CRP analyzer using immunoturbidimetry has been verified to be qual ified, which can meet the clinical requirem ents
for the detection of CRP in the whole blood samples in the clinical laboratory.
刘玲玲1，宿亚菲2，张乐1，陈冬哲1，王召宝1，邢芳林1，杨琳1，刘立存1，孙雯雯1. DH71CRP血液分析仪在测定C反应蛋白中的性能验证[J]. 中国医疗设备, 2019, 34(7): 69-72.
LIU Lingling1, SU Yafei2, ZHANG Le1, CHEN Dongzhe1, WANG Zhaobao1,XING Fanglin1, YANG Lin1, LIU Licun1, SUN Wenwen1. Performance Qualification of DH71CRP Hematology Analyzer for CRP. China Medical Devices, 2019, 34(7): 69-72.
