Verification of the analytical range of a new reagent for full-range C-reactive protein determination.
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.