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

Abstract Background High sensitivity cardiac troponin (hs-cTn) assays run on instruments suitable for small laboratories are a desirable commodity for rural cardiovascular testing. The Quidel TriageTrue hs-cTnI assay was recently approved as a laboratory test in Canada. This study aimed to verify the analytical performance of this novel hs-cTnI assay and perform a head-to-head comparison with other hs-cTn assays. Methods A precision study was performed for 5–6 days with 5 replicates daily using quality control (QC) materials and patient plasma pools corresponding to the clinical decision thresholds. Linearity was assessed based on preparation of patient plasma pools at target troponin concentrations spanning the analytical measuring range. Fresh samples from coronary intensive care unit patients and healthy volunteers were used for head-to-head comparison of the TriageTrue hs-cTnI assay against several hs-cTnI (Beckman Access and Siemens Atellica) and hs-cTnT (Roche Cobas e801) assays. Assay-specific overall 99th percentile upper reference limits (URL) were used to assess analytical concordance. Risk reclassification was analytically assessed by comparing the decision cutpoints using the 2023 European Society of Cardiology (ESC) 0/1 h algorithm for the different hs-cTn assays. Results QC and patient samples demonstrated a coefficient of variation (CV) <10% near the overall 99th percentile URL. TriageTrue hs-cTnI assay has a >90% analytical concordance at the 99th percentile URL and <10% risk reclassification compared to the Beckman Access and Siemens Atellica hs-cTnI assays. Conclusions The novel TriageTrue hs-cTnI assay had comparable analytical performance as other hs-cTnI assays and can be considered in lower volume health care delivery settings with limited laboratory space.