Evaluation of two new high-sensitivity methods for C-reactive protein

Area of Science:

• Clinical Chemistry
• Biomarker Assay Development
• Laboratory Medicine

Background:

• High-sensitivity C-reactive protein (hs-CRP) assays are crucial for routine laboratory diagnostics.
• A single, reliable hs-CRP method across all concentration ranges is needed for practical implementation.
• Two novel hs-CRP assays were evaluated for their performance in both low and high concentration ranges.

Purpose of the Study:

• To evaluate the performance of two new hs-CRP assays: BN ProSpec and Synchron LX 20 PRO.
• To compare these new assays against an existing hs-CRP IMMAGE method and a routine Synchron LX 20 CRP method.
• To assess assay linearity, precision, and susceptibility to sample turbidity.

Main Methods:

• Comparative analytical evaluation of BN ProSpec hs-CRP and Synchron LX 20 PRO hs-CRP assays.
• Reference method: hs-CRP IMMAGE assay; high concentration comparison: routine Synchron LX 20 CRP assay.
• Analysis of 521 patient samples, estimation of reference values in 291 blood donors, and turbidity influence assessment.

Main Results:

• BN ProSpec demonstrated linearity down to 0.2 mg/L with precision (CV) < or =3.7% across the 0.2-250 mg/L range.
• Synchron LX 20 PRO showed some linearity discrepancies and precision (CV) < or =6.1%.
• Significant discrepancies between methods were noted, particularly in high concentration ranges; BN ProSpec outperformed Synchron LX 20 PRO regarding precision and turbidity influence.

Conclusions:

• The BN ProSpec hs-CRP method exhibited superior overall performance compared to the Synchron LX 20 PRO hs-CRP method.
• While Synchron LX 20 PRO showed acceptable performance, standardization across hs-CRP assays requires significant improvement.
• Further efforts are necessary to achieve assay standardization for both low and high concentration ranges in hs-CRP testing.