Peter A Kavsak1, Shawn E Mondoux2, Jonathan Sherbino2, Jinhui Ma3, Natasha Clayton4, Stephen A Hill5, Matthew McQueen5, Shamir R Mehta6, Lauren E Griffith3, P J Devereaux6, Andrew Worster2. 1. Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: kavsakp@mcmaster.ca. 2. Division of Emergency Medicine, McMaster University, Hamilton, ON, Canada. 3. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. 4. Department of Medicine, McMaster University, Hamilton, ON, Canada. 5. Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada. 6. Division of Cardiology, and Population Health Research Institute, McMaster University, Hamilton, ON, Canada.
Abstract
BACKGROUND: As more companies obtain regulatory approval for high-sensitivity cardiac troponin (hs-cTn) assays there is an urgent need for independent analytical and clinical evaluations. To this end, we have evaluated Ortho Clinical Diagnostics' hs-cTnI assay and compared it to their contemporary cTnI-ES assay in emergency department (ED) patients with suspected acute coronary syndrome (ACS). METHODS: The study cohort consisted of ED patients (n = 906) with symptoms suggestive of ACS who had Ortho hs-cTnI and cTnI-ES results at presentation and 3 h (with calculated delta (0-3 h) defined as the absolute concentration difference between paired results). The primary composite outcome was 7-day myocardial infarction (MI) or cardiovascular death, with secondary analyses performed for 7-day MI and index-MI. Analytical imprecision testing (i.e., coefficient of variation; CV), receiver-operating characteristic (ROC) curve analyses with area under the curve (AUC), and diagnostic parameters (sensitivity/specificity/predictive values) were calculated. RESULTS: The hs-cTnI assay had superior precision compared to the cTnI-ES assay below 5 ng/L in EDTA plasma (hs-cTnI CV ≤ 15% versus cTnI-ES CV ≥ 85%). The AUCs were higher for hs-cTnI as compared to cTnI-ES at 0 h (0.88 vs. 0.85), 3 h (0.94 vs. 0.92), and the delta (0-3 h) value (0.91 vs. 0.85) for the primary composite outcome (p < 0.05). At 3 h, the sensitivity/specificity for index-MI was ≥97%/≥82%, for 7-day MI was ≥89%/≥84%, and for the primary composite outcome was ≥90%/≥85% using the manufacturer's sex-specific 99th-percentile cutoffs. CONCLUSION: The Ortho hs-cTnI assay has superior analytical and clinical performance over their contemporary cTnI-ES assay in evaluating ED patients with symptoms suggestive of ACS.
BACKGROUND: As more companies obtain regulatory approval for high-sensitivity cardiac troponin (hs-cTn) assays there is an urgent need for independent analytical and clinical evaluations. To this end, we have evaluated Ortho Clinical Diagnostics' hs-cTnI assay and compared it to their contemporary cTnI-ES assay in emergency department (ED) patients with suspected acute coronary syndrome (ACS). METHODS: The study cohort consisted of ED patients (n = 906) with symptoms suggestive of ACS who had Ortho hs-cTnI and cTnI-ES results at presentation and 3 h (with calculated delta (0-3 h) defined as the absolute concentration difference between paired results). The primary composite outcome was 7-day myocardial infarction (MI) or cardiovascular death, with secondary analyses performed for 7-day MI and index-MI. Analytical imprecision testing (i.e., coefficient of variation; CV), receiver-operating characteristic (ROC) curve analyses with area under the curve (AUC), and diagnostic parameters (sensitivity/specificity/predictive values) were calculated. RESULTS: The hs-cTnI assay had superior precision compared to the cTnI-ES assay below 5 ng/L in EDTA plasma (hs-cTnI CV ≤ 15% versus cTnI-ES CV ≥ 85%). The AUCs were higher for hs-cTnI as compared to cTnI-ES at 0 h (0.88 vs. 0.85), 3 h (0.94 vs. 0.92), and the delta (0-3 h) value (0.91 vs. 0.85) for the primary composite outcome (p < 0.05). At 3 h, the sensitivity/specificity for index-MI was ≥97%/≥82%, for 7-day MI was ≥89%/≥84%, and for the primary composite outcome was ≥90%/≥85% using the manufacturer's sex-specific 99th-percentile cutoffs. CONCLUSION: The Ortho hs-cTnI assay has superior analytical and clinical performance over their contemporary cTnI-ES assay in evaluating ED patients with symptoms suggestive of ACS.
Authors: Peter A Kavsak; Joshua O Cerasuolo; Dennis T Ko; Jinhui Ma; Jonathan Sherbino; Shawn E Mondoux; Natasha Clayton; Stephen A Hill; Matthew McQueen; Lauren E Griffith; Shamir R Mehta; Richard Perez; Hsien Seow; P J Devereaux; Andrew Worster Journal: CMAJ Open Date: 2020-11-02
Authors: Peter A Kavsak; Shawn E Mondoux; Janet Martin; Mark K Hewitt; Lorna Clark; Nadia Caruso; Ching-Tong Mark; V Tony Chetty; Craig Ainsworth; Andrew Worster Journal: J Cardiovasc Dev Dis Date: 2021-03-23