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