Original Article
The preparation and evaluation of CRP trueness verificator: homogeneity, stability and commutability
Chunying Wu, Tingting Zhao, Shunli Zhang, Huaian Ma, Wei Liu, Rui Zhang, Yuhong Yue, Yufang Liang, Qingtao Wang
Published 2019-03-11
Cite as Chin J Lab Med, 2019, 42(3): 204-208. DOI: 10.3760/cma.j.issn.1009-9158.2019.03.011
Abstract
ObjectiveTo prepare the trueness verification materials of C-reactive protein (CRP) and evaluate its homogeneity, stability and commutability.
MethodsThe 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.
ResultsA 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<F0.05(14,30); On the condition of room temperature, 2-8 ℃ and -80 ℃, these materials were stable for 7 days and 44 months respectively, the slope of the linear equation of | b1 | less than t0.95,n-2·s(b1), there was no statistically significant difference between the slope and zero, the stability is satisfied. The materials and the dilution series of ERM-DA 474/IFCC also showed good commutability among patient sera in 10 systems.
ConclusionsThe trueness verification materials of C-reactive protein (CRP) showed good homogeneity, stability and commutability. The dilution series ERM DA-474/IFCC also have good commutability. These provided experimental support for the value transfer and application of the trueness verification materials.
Key words:
C-reactive protein; Reference standards; Protein stability; Analytic sample preparation methods
Contributor Information
Chunying Wu
Department of Clinical Laboratory, Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing 101100, China
Tingting Zhao
Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing Center for Clinical Laboratories, Beijing 100020, China
Shunli Zhang
Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing Center for Clinical Laboratories, Beijing 100020, China
Huaian Ma
Department of Clinical Laboratory, Eye Hospital China Academy of Chinese Medical Sciences, Beijing 100040, China
Wei Liu
Department of Clinical Laboratory, Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing 101100, China
Rui Zhang
Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing Center for Clinical Laboratories, Beijing 100020, China
Yuhong Yue
Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing Center for Clinical Laboratories, Beijing 100020, China
Yufang Liang
Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing Center for Clinical Laboratories, Beijing 100020, China
Qingtao Wang
Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing Center for Clinical Laboratories, Beijing 100020, China
