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Verification of the analytical range of a new reagent for full-range C-reactive protein determination
Laurence Piéroni1, Najette Chahbani, Bernard Hainque
1Service de Biochimie Métabolique, Groupe Hospitalier Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Paris, France. laurence.pieroni@psl.aphp.fr
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.
