Improve the consistency of C-reactive protein test results using trueness control material
10.3760/cma.j.issn.1009-8158.2019.02.013
- VernacularTitle:采用正确度验证物质改进C反应蛋白检测结果一致性
- Author:
Shunli ZHANG
1
;
Chunying WU
;
Huaian MA
;
Wei LIU
;
Rui ZHANG
;
Yuhong YUE
;
Yufang LIANG
;
Tingting ZHAO
;
Qingtao WANG
Author Information
1. 首都医科大学附属北京朝阳医院检验科
- Keywords:
C-reactive protein;
Calibration;
Reference standards;
Reproducibility of results
- From:
Chinese Journal of Laboratory Medicine
2019;42(2):146-150
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the CRP harmonization by calibration using commutable trueness verification materials. Methods High 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. Results After 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). Conclusions Afterthe calibration which contained five linear concentration points of CRP trueness verification materials by weighing method, both harmonization and trueness of CRP were improved.
