[Chemiluminescent immunoassay for high-sensitivity C-reactive protein]

Area of Science:

• Biochemistry
• Immunology
• Assay Development

Context:

• Cardiovascular disease (CVD) risk stratification and inflammatory bowel disease (IBD) prognosis rely on accurate C-reactive protein (CRP) measurement.
• Existing CRP assays may lack the sensitivity or reliability required for precise risk assessment.

Purpose:

• To develop and validate a novel, high-sensitivity C-reactive protein quantifiable chemiluminescent immunoassay (hs-CRP CLIA).
• To assess the accuracy, reliability, and performance characteristics of the developed hs-CRP CLIA.

Summary:

• High-purity native CRP was used to generate monoclonal antibodies (mAbs), with mAbs 10C5 and 10C11 selected for hs-CRP CLIA development.
• The hs-CRP CLIA demonstrated excellent linearity (0.04-20.38 mg/L), accuracy (99% recovery), and reproducibility (CVs 4.2%-11.5%).
• The assay showed no cross-reactivity with other serum components and correlated well with a commercial hs-CRP ELISA kit.

Impact:

• The developed hs-CRP CLIA is an accurate and reliable tool for quantifying hs-CRP in serum.
• This assay can potentially improve cardiovascular disease risk assessment and inflammatory bowel disease prognosis.