Original Article
Improve the consistency of C-reactive protein test results using trueness control material
Shunli Zhang, Chunying Wu, Huaian Ma, Wei Liu, Rui Zhang, Yuhong Yue, Yufang Liang, Tingting Zhao, Qingtao Wang
Published 2019-02-11
Cite as Chin J Lab Med, 2019, 42(2): 146-150. DOI: 10.3760/cma.j.issn.1009-8158.2019.02.013
Abstract
ObjectiveTo explore the CRP harmonization by calibration using commutable trueness verification materials.
MethodsHigh and low level of CRP concentrations trueness verification materials(H and L) were prepared by Beijing center for clinical laboratories. Thesetrueness verification materials were diluted to 5 calibration points(5L, 4L+1H, 3L+2H, 1L+4H, 5H) by weighing method, respectively. These 5 points were used to calibrate four different brands of CRP detection system (Diasys, Leadman, Siemens and Roche) instead of the original procedure. Sera from 21 patients and the international standard ERM DA-474/IFCC were used to compare harmonization and trueness after calibration. Each sample above was measured twice.
ResultsAfter calibration, the median of CV was reduced from 19.33% to 2.92% among 21 patient samples, less than the optimal CV based on biological variability (CV=10.6%). Compared with Desai, the slopes were closer to 1 from 0.90-1.09 to 0.93-0.96 after calibration. Meanwhile, if ERM-DA474/IFCC was used as the trueness verification materials, the absolute bias wasreduced from 3.08-11.07 mg/L to 0.52-2.97 mg/L which was close to theuncertainty of itself (2.5 mg/L).
ConclusionsAfterthe calibration which contained five linear concentration points of CRP trueness verification materials by weighing method, both harmonization and trueness of CRP were improved.
Key words:
C-reactive protein; Calibration; Reference standards; Reproducibility of results
Contributor Information
Shunli Zhang
Beijing Chaoyang Hospital Affiliated to Capital Medical University, Department of Clinical Laboratory, Beijing 100020, China
Chunying Wu
Department of Clinical Laboratory, Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing 101100, China
Huaian Ma
Eye Hospital, China Academy of Chinese Medical Sciences, Beijing100040, China
Wei Liu
Department of Clinical Laboratory, Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing 101100, China
Rui Zhang
Beijing Chaoyang Hospital Affiliated to Capital Medical University, Department of Clinical Laboratory, Beijing 100020, China
Yuhong Yue
Beijing Chaoyang Hospital Affiliated to Capital Medical University, Department of Clinical Laboratory, Beijing 100020, China
Yufang Liang
Beijing Chaoyang Hospital Affiliated to Capital Medical University, Department of Clinical Laboratory, Beijing 100020, China
Tingting Zhao
Beijing Chaoyang Hospital Affiliated to Capital Medical University, Department of Clinical Laboratory, Beijing 100020, China
Qingtao Wang
Beijing Chaoyang Hospital Affiliated to Capital Medical University, Department of Clinical Laboratory, Beijing 100020, China
