Verification of a Novel High Sensitivity Troponin I Assay for Implementation in Rural Clinical Laboratories

Area of Science:

• Clinical Chemistry
• Cardiovascular Diagnostics
• Laboratory Medicine

Background:

• High-sensitivity cardiac troponin (hs-cTn) assays are crucial for cardiovascular testing, especially in rural settings requiring instruments for small laboratories.
• The Quidel TriageTrue hs-cTnI assay has recently received approval in Canada.
• This study aims to validate the analytical performance of this new hs-cTnI assay and compare it with existing hs-cTn assays.

Purpose of the Study:

• To verify the analytical performance of the novel Quidel TriageTrue hs-cTnI assay.
• To conduct a head-to-head comparison of the TriageTrue hs-cTnI assay against other high-sensitivity troponin assays.
• To assess the suitability of the TriageTrue hs-cTnI assay for smaller laboratory settings.

Main Methods:

• Precision studies were conducted using quality control materials and patient plasma pools.
• Assay linearity was assessed across the analytical measuring range.
• Head-to-head comparisons involved fresh patient samples and healthy volunteers against Beckman Access, Siemens Atellica (hs-cTnI), and Roche Cobas e801 (hs-cTnT) assays.
• Analytical concordance and risk reclassification were evaluated using the 99th percentile upper reference limits and the 2023 ESC 0/1 h algorithm.

Main Results:

• The TriageTrue hs-cTnI assay demonstrated coefficients of variation (CV) <10% near the 99th percentile upper reference limit.
• Analytical concordance exceeded 90% at the 99th percentile upper reference limit when compared to Beckman Access and Siemens Atellica hs-cTnI assays.
• Risk reclassification was less than 10% compared to other hs-cTnI assays.

Conclusions:

• The Quidel TriageTrue hs-cTnI assay exhibits comparable analytical performance to existing hs-cTnI assays.
• This novel assay is a viable option for healthcare settings with limited laboratory space and lower testing volumes.
• The assay supports accurate cardiovascular testing in diverse laboratory environments.