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Verification of the analytical range of a new reagent for full-range C-reactive protein determination
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Laurence Piéroni
Published/Copyright:
December 5, 2008
Abstract
Background: The aim of this study was to verify the analytical range of the DIAgam XS Cardio NanoGold C-reactive protein (CRP) method proposed as a full-range assay.
Methods: For this purpose, analytical specifications were verified according to the Clinical and Laboratory Standards Institute specifications and a comparison was made with the reference method for the cardiovascular risk assessment, the CardioPhase high sensitivity CRP from Siemens Healthcare Diagnostics.
Results: Our results showed that the immunoturbidimetric assay of CRP using reagents from DIAgam laboratory gave accurate and precise measurements from 0.42 to 265 mg/L. The performances in limits of detection and linearity allowed a full-range determination of CRP concentrations. The comparison with the reference method for the determination of cardiovascular risk was also accurate.
Conclusions: In conclusion, the DIAgam reagents might be used in a routine laboratory for the detection of acute inflammation as well as for evaluation of cardiovascular risk.
Clin Chem Lab Med 2009;47:109–11.
Received: 2008-7-18
Accepted: 2008-10-5
Published Online: 2008-12-05
Published Online: 2008-12-5
Published in Print: 2009-01-01
©2009 by Walter de Gruyter Berlin New York
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