Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay.

BACKGROUND

Point-of-care (POC) high-sensitivity cardiac troponin assays may further accelerate the diagnosis of myocardial infarction (MI).

OBJECTIVES

This study sought to assess the clinical and analytical performance of the novel high-sensitivity cardiac troponin I (hs-cTnI)-SPINCHIP POC test.

METHODS

Adult patients presenting with acute chest discomfort to the emergency department were enrolled in an international, diagnostic, multicenter study. The final diagnosis was centrally adjudicated by 2 independent cardiologists using all clinical information. We compared the discriminatory performance of hs-cTnI-SPINCHIP with current established central laboratory assays and derived an assay-specific hs-cTnI-SPINCHIP 0/1-hour algorithm. Secondary analyses included sample type comparisons (whole blood, fresh/frozen plasma, and capillary finger prick) and precision analysis.

RESULTS

MI was the adjudicated final diagnosis in 214 (19%) of 1,102 patients. Area under the receiver-operating characteristic curve was 0.94 (95% CI: 0.92-0.95) for hs-cTnI-SPINCHIP vs 0.94 (95% CI: 0.92-0.95) for hs-cTnI-Architect (P = 0.907) and 0.93 (95% CI: 0.91-0.95) for high-sensitivity cardiac troponin T Elecsys (P = 0.305). A cutoff <7 ng/L at presentation (if chest pain onset was >3 hours) or <7 ng/L together with a 0/1-hour delta of <4 ng/L ruled out 51% with a sensitivity and negative predictive value of 100% (95% CI: 97.7%-100%) and 100% (95% CI: 99.0%-100%), respectively. A hs-cTnI-SPINCHIP concentration ≥36 ng/L or a 0/1-hour delta ≥11 ng/L ruled in 27% with a specificity and positive predictive value of 90.9% (95% CI: 88.3%-92.9%) and 72.9% (95% CI: 66.4%-78.6%), respectively. Bootstrap internal validation confirmed excellent diagnostic performance. High agreement was observed between different sample types.

CONCLUSIONS

The SPINCHIP hs-cTnI POC test has very high diagnostic accuracy. Its assay-specific 0/1-hour algorithm achieved very high sensitivity/negative predictive value and specificity/positive predictive value for rule-out/in MI. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE] Study [APACE]; NCT00470587).

Informations de copyright

Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The APACE study was supported by research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the University Hospital Basel, the University of Basel, Abbott, Beckman Coulter, Brahms, Idorsia, LSI Medience Corporation, Ortho Clinical Diagnostics, Quidel, Roche, Siemens, Singulex, and SpinChip Diagnostics. The study group from Akershus University Hospital was supported by the Norwegian South-East Regional Health Authority to Akershus Clinical Research Center, Stiftelsen Kristian Gerhard Jebsen to K.G. Jebsen Center for Cardiac Biomarkers (grant number SKGJ-MED-024), and SpinChip Diagnostics AS. SpinChip Diagnostics was involved in planning the design of the analytical part of the study and conducted the measurements of the analytical part of the study and the diagnostic study blinded to all clinical data. Akershus University Hospital has a collaboration agreement with SpinChip Diagnostics and SpinChip Diagnostics provided support to Akershus University Hospital for this study.Dr Koechlin has received research grants from the Swiss Heart Foundation, the University of Basel, the Swiss Academy of Medical Sciences, and the Gottfried and Julia Bangerter-Rhyner Foundation, as well as the “Freiwillige Akademische Gesellschaft Basel;” and has received speaker honoraria from Roche Diagnostics, Abbott, Polymedco, and Siemens, all outside of the submitted work and paid to the institution. Dr Boeddinghaus has received research grants from the University of Basel and the Division of Internal Medicine, the Swiss Academy of Medical Sciences, and the Gottfried and Julia Bangerter-Rhyner-Foundation; and has received speaker honoraria/consulting honoraria from Siemens and Roche Diagnostics. Dr Lopez-Ayala has received research grants from the Swiss Heart Foundation (FF20079 and FF21103); and has received speaker honoraria from Quidel, paid to the institution, outside the submitted work. Dr Nestelberger has received research support from the Swiss National Science Foundation (P400PM_191037/1), the Prof. Dr Max Cloëtta Foundation, the Margarete und Walter Lichtenstein-Stiftung (3MS1038), and the University Hospital Basel; and has received speaker/consulting honoraria or research support from Edwards Lifesciences, Boston Scientific, Medtronic, Abbott, Beckman Coulter, Bayer, Ortho Clinical Diagnostics, and Orion Pharma, outside the submitted work. Dr Wildi has received research funding from the Prince Charles Hospital Foundation, the Wesley Medical Research Foundation, the University of Basel; and has received a PhD scholarship from the University of Queensland, Brisbane, Australia. Dr Rubini has received speaker honoraria from Abbott; and has received research grants from the Swiss Heart Foundation. Drs Størvold and Broughton are employees at SpinChip Diagnostics. Dr Røsjø has received consulting fees from SpinChip Diagnostics. Dr Omland has received research support from Abbott, CardiNor, Novartis, and Roche; and has received speaker/consulting honoraria from Abbott, Bayer, CardiNor, Novo Nordisk, and Roche. Dr Røsjø has received consulting fees from CardiNor AS and Thermo Fisher BRAHMS; and has a biomarker patent with CardiNor AS, outside the submitted work. Dr Schirmer has received lecture fees from Novartis, AstraZeneca, Amgen, Sanofi, and a joint venture project with Novartis. Dr Mueller has received research support from the Swiss National Science Foundation, the Swiss Heart Foundation, the University Hospital Basel, the University of Basel, Abbott, AstraZeneca, Beckman Coulter, Brahms, Idorsia, Novartis, LSI Medience Corporation, Ortho Clinical Diagnostics, Quidel, Roche, Siemens, Singulex, Sphingotec, and SpinChip Diagnostics; and has received speaker/consulting honoraria from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Idorsia, Novartis, Osler, Roche, Sanofi, Singulex, and SpinChip Diagnostics, all paid to the institution. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.