Performance characteristics of the ARCHITECT Galectin-3 assay

Area of Science:

• Clinical Chemistry
• Biomarker Analysis
• Cardiovascular Diagnostics

Background:

• Galectin-3 is an emerging biomarker for heart failure and cardiovascular disease risk.
• Increased Galectin-3 levels are commonly observed in at-risk patient populations.
• Accurate measurement of Galectin-3 is crucial for patient management.

Purpose of the Study:

• To evaluate the analytical performance of the Galectin-3 assay on Abbott ARCHITECT platforms.
• To assess the assay's suitability for clinical use in diagnosing and monitoring cardiovascular conditions.
• To validate the assay across two testing sites for robust performance data.

Main Methods:

• Analytical performance was assessed including imprecision, interference, and linearity.
• Limits of Blank (LoB), Detection (LoD), and Quantitation (LoQ) were determined.
• Method comparison with ELISA and reference intervals were established using EDTA plasma.

Main Results:

• Total imprecision (%CV) was consistently low, ≤6.0%.
• The assay demonstrated good linearity (slopes and R² ≈ 1.0) and acceptable correlation with ELISA (R² 0.93–0.97).
• Established reference intervals were 18.7 ng/mL (i1000SR) and 17.9 ng/mL (i2000SR).

Conclusions:

• The Abbott Galectin-3 assay exhibits acceptable analytical performance on ARCHITECT i1000(SR) and i2000(SR) systems.
• The assay is suitable for measuring Galectin-3 levels in plasma for cardiovascular risk assessment.
• This validates the assay for use in clinical laboratories managing heart failure patients.