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Abstract

ORIGINAL ARTICLEApplication of Commutable ERM-DA474/IFCC for Harmonization of C-reactive Protein Measurement Using Five Analytical Assays by Chunying Wu, Shunli Zhang, Wei Liu, Jie Zeng, Tingting Zhao, Yuhong Yue, Rui Zhang, Huaian Ma, Qingtao Wang

Background: ERM-DA474/IFCC has been used as a reference material for C-reactive protein (CRP) since 2012. However, the commutabilities and the capacity for harmonizing CRP results of the material and its dilutions have not yet been reported. In this study, we aimed to evaluate the harmonization of CRP results using commutable ERM-DA474/IFCC.
Methods: Twenty-one serum samples were collected and split into five vials. The samples were then analyzed using five popular assays (Siemens BN II, Beckman Immage 800, Roche, Diasys, and Leadman). ERM-DA474/IFCC and four dilutions of healthy human serum containing low levels of CRP were also analyzed using the five assays described above. Commutability was assessed using the Roche, Diasys, and Leadman assays. Clinical sample results from assays were recalibrated based on ERM-DA474/IFCC and its dilutions.
Results: There were significant variations among the five assays for CRP measurement. The slopes ranged from 0.60 to 1.60, and the BN II and Leadman assays showed significant negative and positive systemic biases, respectively. ERM-DA474/IFCC and its dilutions exhibited commutability among the three assays. After recalibration, the slope was reduced to 0.76 - 1.27.
Conclusions: Harmonization was not ideal for CRP measurement. ERM-DA474/IFCC may play a role in improving harmonization for CRP measurement.

DOI: 10.7754/Clin.Lab.2017.170626