Analyzer transfer of a broad range high-sensitivity C-reactive protein immunoassay

Area of Science:

• Clinical Chemistry
• Biomarker Analysis
• Laboratory Medicine

Background:

• C-reactive protein (CRP) is crucial for diagnosing inflammation and assessing cardiovascular risk.
• Current methods often require separate assays for different CRP concentration ranges (0.1-10 mg/L for cardiovascular risk, 5-300 mg/L for inflammation).
• This necessitates using multiple assay protocols or methods in clinical laboratories.

Purpose of the Study:

• To adapt the Roche C-Reactive Protein (Latex) kit for the Hitachi Modular P800 analyzer.
• To establish a single, broad-range assay for CRP measurement on the Hitachi Modular P800.
• To validate the adapted assay against existing high-sensitivity and traditional CRP assays.

Main Methods:

• Adaptation of the Roche C-Reactive Protein (Latex) kit for the Hitachi Modular P800 analyzer.
• Validation of the adapted assay against established high-sensitivity and traditional CRP assays.
• Performance evaluation including measuring range and imprecision analysis.

Main Results:

• Successful adaptation and validation of the CRP assay on the Hitachi Modular P800.
• The adapted assay demonstrated a broad measuring range of 0.10-171 mg/L.
• The method exhibited an imprecision of less than 5.5% and correlated well with other assays.

Conclusions:

• The adapted CRP assay offers a practical, broad-range solution for clinical laboratories.
• This single assay can be used for both inflammation and cardiovascular risk assessment.
• The method enhances efficiency and practicality in routine CRP measurements.