[Analytical comparison and clinical acceptability of two immunoturbidimetric methods for measuring CRP in paediatrics: application on the Roche Cobas Integra^® 400+ and DiaSys Respons^® 920 systems].

Authors

Younes Benchaar, Adel Gouri, Mohamed Reda Djeghri, Sami Ramzi Djeghri, Saddek Benharkat

Published in

Annales de biologie clinique. Volume 84. Issue 5. Pages 0. Oct 12, 2026. Epub Oct 12, 2026.

Abstract

C-reactive protein (CRP) is a widely used biomarker of acute inflammation, particularly in paediatrics. Immunoturbidimetric methods are commonly used for CRP measurement; however, analytical differences between platforms may affect result comparability. This study aimed to assess the analytical comparability of two immunoturbidimetric methods implemented on different analysers. Fifty-one serum samples were analysed in duplicate using two automated immunoturbidimetric methods: CRP4 on the Roche Cobas Integra® 400+ and CRP FS on the DiaSys Respons® 920. Method comparison included Spearman's rank correlation, Passing-Bablok regression, Bland-Altman analysis, and assessment of classification agreement using Cohen's kappa coefficient, within the general framework of CLSI EP09. CRP concentrations measured by CRP4 were significantly higher than those obtained with CRP FS (p = 0.001), with respective medians of 16.5 and 11.0 mg/L. The methods showed a strong correlation (Spearman's ρ = 0.952; p < 0.05), without implying analytical agreement. Passing-Bablok regression indicated both constant and proportional bias, whereas Bland-Altman analysis showed a mean bias of -4.04 mg/L, with 95% limits of agreement ranging from -13.48 to 5.40 mg/L. The observed total error was 38.1%, remaining below the 42% analytical performance limit used in this study but slightly exceeding the more stringent 36.5% performance specification. The two methods showed overall acceptable analytical comparability under the conditions of this study but should not be considered fully interchangeable. Whenever possible, the same analytical method should be maintained for longitudinal patient monitoring.

PMID:
42862643
Bibliographic data and abstract were imported from PubMed on 13 Oct 2026.

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