Analytical Verification of a Point-of-Care High-Sensitivity Troponin I Assay

Area of Science:

• Clinical Chemistry
• Point-of-Care Testing
• Cardiovascular Diagnostics

Background:

• The QuidelOrtho TriageTrue high-sensitivity troponin I (hs-TnI) assay is a validated point-of-care (POC) diagnostic tool.
• Independent verification of its analytical performance and concordance with other assays was necessary.

Purpose of the Study:

• To independently verify the analytical performance of the TriageTrue hs-TnI assay.
• To assess the assay's concordance with other hs-TnI assays and secondary POC devices.

Main Methods:

• Precision studies (intra-assay, inter-analyzer, inter-lot) were conducted using whole blood samples.
• Interference from hemolysis was evaluated.
• Concordance was assessed using Pearson correlation and kappa statistics against other POC and laboratory analyzers.
• Comparison with secondary POC devices was performed against prespecified difference limits.

Main Results:

• Intra-assay precision CVs ranged from 2.8% to 25% across the measuring interval.
• Minimal interference was observed from hemolysis up to 10 g/L.
• High correlation coefficients (0.89-0.99) were found with most assays, except for Roche hs-TnT (0.79).
• Comparisons with 8 secondary analyzers showed results within acceptable limits.

Conclusions:

• The TriageTrue hs-TnI assay demonstrated performance consistent with the manufacturer's claims.
• The assay exhibits acceptable analytical characteristics for point-of-care use in medical settings.