Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay - Koechlin, L.; Boeddinghaus, J.; Lopez-Ayala, P.; Reber, C.; Nestelberger, T.; Wildi, K.; Spagnuolo, C. C.; Strebel, I.; Glaeser, J.; Bima, P.; Crisanti, L.; Herraiz-Recuenco, L.; et al. (J Am Coll Cardiol, 2024)
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).
Keywords: journalArticle; " and has received speaker honoraria; "Freiwillige Akademische Gesellschaft Basel; *Myocardial Infarction/blood/diagnosis; *Troponin I/blood; Abbott, CardiNor, Novartis, and Roche; Aged; Authority to Akershus Clinical Research Center, Stiftelsen Kristian Gerhard; Bangerter-Rhyner-Foundation; Basel; Beckman Coulter, Bayer, Ortho Clinical Diagnostics, and Orion Pharma, outside the; 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; Diagnostics and SpinChip Diagnostics provided support to Akershus University; Female; Foundation, the Margarete und Walter Lichtenstein-Stiftung (3MS1038), and the; Heart Foundation, the University of Basel, the Swiss Academy of Medical Sciences,; Hospital Basel, the University of Basel, Abbott, AstraZeneca, Beckman Coulter,; Hospital Foundation, the Wesley Medical Research Foundation, the University of; Hospital for this study.Dr Koechlin has received research grants from the Swiss; Humans; Jebsen to K.G. Jebsen Center for Cardiac Biomarkers (grant number SKGJ-MED-024),; Male; Middle Aged; 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; 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; Swiss Academy of Medical Sciences, and the Gottfried and Julia; Swiss National Science Foundation, the Swiss Heart Foundation, the University; University Hospital Basel; University Hospital was supported by the Norwegian South-East Regional Health; acute coronary syndrome; analytical part of the study and the diagnostic study blinded to all clinical; and; and SpinChip Diagnostics AS. SpinChip Diagnostics was involved in planning the; 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 the Gottfried and Julia Bangerter-Rhyner Foundation, as well as the; biomarker; biomarker patent with CardiNor AS, outside the submitted work. Dr Schirmer has; data. Akershus University Hospital has a collaboration agreement with SpinChip; design of the analytical part of the study and conducted the measurements of the; fees from SpinChip Diagnostics. Dr Omland has received research support from; 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; honoraria from Abbott, Bayer, CardiNor, Novo Nordisk, and Roche. Dr Rosjo has