A comparison study between wide-range and high-sensitivity C-reactive protein assays (Roche Cobas c702) for low...

Area of Science:

• Clinical Chemistry
• Cardiovascular Risk Assessment
• Biomarker Analysis

Background:

• Low concentration C-reactive protein (CRP) is a significant prognostic indicator for individuals with cardiovascular risks.
• Accurate measurement of low CRP levels is crucial for effective cardiovascular risk stratification.

Purpose of the Study:

• To compare the performance of the Roche wr-CRP method against the hs-CRP method for determining low CRP concentrations (<20 mg/L).
• To evaluate the concordance and agreement between the two methods on the Roche Cobas c702 analyzer.

Main Methods:

• Analyzed 200 patient samples for low CRP concentration (<20 mg/L) using both wr-CRP and hs-CRP methods on a Roche Cobas c702 analyzer.
• Employed Spearman's rho for correlation analysis and Deming regression for assessing method agreement and bias.
• Assessed concordance for cardiovascular risk stratification based on established CRP cutoffs.

Main Results:

• High correlation observed between wr-CRP and hs-CRP methods (Spearman's rho = 0.995).
• Median method difference was 0.120 mg/L with a median percent difference of 7.34%, well within acceptable bias limits (<12.50%).
• 96.0% concordance in risk stratification results between the two methods (kappa = 0.937).

Conclusions:

• The Roche wr-CRP and hs-CRP assays demonstrate high concordance for measuring low CRP concentrations.
• Wr-CRP can serve as a viable alternative to hs-CRP on the Roche Cobas c702 analyzer for cardiovascular risk assessment.
• The convenience and lower cost of the wr-CRP assay make it an attractive option for clinical laboratories.