The preparation and evaluation of CRP trueness verificator: homogeneity, stability and commutability
10.3760/cma.j.issn.1009-9158.2019.03.011
- VernacularTitle:C反应蛋白正确度验证物质均匀性和稳定性及其互换性
- Author:
Chunying WU
1
;
Tingting ZHAO
;
Shunli ZHANG
;
Huaian MA
;
Wei LIU
;
Rui ZHANG
;
Yuhong YUE
;
Yufang LIANG
;
Qingtao WANG
Author Information
1. 首都医科大学附属北京潞河医院检验科 101100
- Keywords:
C-reactive protein;
Reference standards;
Protein stability;
Analytic sample preparation methods
- From:
Chinese Journal of Laboratory Medicine
2019;42(3):204-208
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare the trueness verification materials of C-reactive protein (CRP) and evaluate its homogeneity, stability and commutability. Methods The high and low CRP concentrations trueness verification materials were from patient leftover sera which were pooled, mixed thoroughly, filtered and aliquoted. The homogeneity, stability and commutability of these materials were evaluated according to CNAS(China National Accreditation Service for Conformity Assessment, CNAS)-GL29:2010 "Reference materials-General and statistical principles for certification (ISO Guide35:2006)"and the Clinical and Laboratory Standards Institute (CLSI) EP30A. The trueness verification materials were used to evaluate the commutability in 10 clinical CRP detection systems, using forty-five patients' leftover sera with different CRP concentration evaluated by Deming regression in EP30A of CLSI. Meanwhile, the commutability of dilution series of ERM DA-474/IFCC were evaluated using the same method. Results A total of two CRP concentration level trueness verification materials were prepared, with high and low concentration levels of 754 and 743 vials, 1 ml each, respectively. The preparation showed good homogeneity (F
