Biochemia Medica, Vol. 16 No. 2, 2006.
Professional paper
Assessment of analytical properties of the Randox full range assay for determination of C-reactive protein concentration in preterm infants and newborns
Nada Vukelić
Ines Vukasović
Elizabeta Topić
Abstract
Introduction: C-reactive protein (CRP) is present in healthy individuals in low concentrations and is routinely determined as an indicator of systemic inflammatory reaction. However, clinical significance of the very low concentrations of CRP encouraged manufacturers to develop sensitive methods that allow CRP determination in a wide range from very low to high concentrations. Such approach is of extraordinary importance in the diagnosis and follow-up of infection in preterm infants and newborns because the onset of sepsis in these patients is characterized by unspecific symptoms and is diagnosed only on the basis of laboratory results.
Aim: Analytical assessment of a new combined Randox Full Range assay for determination of CRP concentration in comparison with Olympus reagents as reference reagents. The measuring range of the new reagent is 0.1-160.0 mg/ L, which should be an advantage over Olympus reagents as they require two reagents and three applications for this measuring range.
Materials and methods: Analytical assessment comprised within-run imprecision, between-run imprecision, inaccuracy and comparative determinations of CRP concentration in patient samples. The examinations were performed in accordance with ECCLS recommendations on Olympus AU 640 instrument.
Results: Satisfactory results were obtained for analytical within-run imprecision (CV ≤ 2.18%), between-run imprecision (CV ≤ 1.64%) and inaccuracy (R ≤ 3.67%). Results of comparative determinations of CRP concentrations in patient samples using reagents by two manufacturers showed a high degree of correlation (r ≤ 0.993).
Conclusion: Based on the obtained results, we may conclude that the Randox Full Range assay is a sensitive and reproducible reagent for determination of CRP concentration.
Keywords
C-reactive protein; sepsis; preterm infants; newborns
Hrčak ID:
9777
URI
Publication date:
20.12.2006.
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