Multicenter Study

. 2024 Aug 20;84(8):726-740.

doi: 10.1016/j.jacc.2024.05.056.

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

Luca Koechlin¹, Jasper Boeddinghaus², Pedro Lopez-Ayala³, Cornelia Reber⁴, Thomas Nestelberger³, Karin Wildi³, Carlos C Spagnuolo³, Ivo Strebel³, Jonas Glaeser³, Paolo Bima³, Luca Crisanti³, Lourdes Herraiz-Recuenco³, Elisa Dubach⁴, Òscar Miró⁵, F Javier Martin-Sanchez⁶, Damian Kawecki⁷, Dagmar I Keller⁸, Michael Christ⁹, Andreas Buser¹⁰, Maria Rubini Giménez¹¹, Gro Leite Størvold¹², Marianne Nordlund Broughton¹², Torbjørn Omland¹³, Magnus N Lyngbakken¹⁴, Helge Røsjø¹⁵, Christian Mueller¹⁶; APACE Investigators

Collaborators, Affiliations

Collaborators

APACE Investigators:
Desiree Wussler¹⁷, Christian Puelacher¹⁷, Gabrielle Huré¹⁷, Katharina Rentsch¹⁸, Danielle M Gualandro¹⁷, Julia Reinhardt¹⁷, Ana Yufera Sanchez¹⁷, Bernhard Okamura¹⁷, Samyut Shrestha¹⁷, Philip Haaf¹⁷, Patrick Badertscher¹⁷, Joan Elias Walter¹⁷, Beatriz López¹⁹, Gemma Martinez-Nadal¹⁹, Esther Rodriguez Adrada²⁰, Jiri Parenica²¹, Arnold von Eckardstein²², Beata Morawiec²³, Piotr Muzyk²³, Henrik Schirmer²⁴

Affiliations

¹ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: luca.koechlin@usb.ch.
² Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.
³ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy.
⁴ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
⁵ GREAT Network, Rome, Italy; Emergency Department, Hospital Clínic, Barcelona, Spain.
⁶ GREAT Network, Rome, Italy; Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain.
⁷ GREAT Network, Rome, Italy; 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland.
⁸ Emergency Department, University Hospital Zurich, Zurich, Switzerland.
⁹ Emergency Department, Kantonsspital Luzern, Lucerne, Switzerland.
¹⁰ Department of Hematology and Blood Bank, University Hospital Basel, University of Basel, Basel, Switzerland.
¹¹ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; Department of Cardiology, University Hospital Valencia, Valencia, Spain.
¹² SpinChip Diagnostics, Oslo, Norway.
¹³ K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.
¹⁴ K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway; Akershus Clinical Research Center, Division of Research and Innovation, Akershus University Hospital, Lørenskog, Norway.
¹⁵ K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Akershus Clinical Research Center, Division of Research and Innovation, Akershus University Hospital, Lørenskog, Norway.
¹⁶ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: christian.mueller@usb.ch.
¹⁷ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel; GREAT network.
¹⁸ Blood Transfusion Centre, Swiss Red Cross, Basel, Switzerland and Department of Hematology, University Hospital Basel, University of Basel, Switzerland.
¹⁹ GREAT network; Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain.
²⁰ Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain.
²¹ Department of Cardiology, University Hospital Brno, Brno, Czech Republic and Medical Faculty, Masaryk University, Brno, Czech Republic.
²² Emergency Department of Laboratory Medicine, University Hospital Zurich, Switzerland.
²³ GREAT network; 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Poland.
²⁴ K. G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.

PMID: 39142727
DOI: 10.1016/j.jacc.2024.05.056

Free article

Multicenter Study

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

Luca Koechlin et al. J Am Coll Cardiol. 2024.

Free article

. 2024 Aug 20;84(8):726-740.

doi: 10.1016/j.jacc.2024.05.056.

Authors

Collaborators

APACE Investigators:
Desiree Wussler¹⁷, Christian Puelacher¹⁷, Gabrielle Huré¹⁷, Katharina Rentsch¹⁸, Danielle M Gualandro¹⁷, Julia Reinhardt¹⁷, Ana Yufera Sanchez¹⁷, Bernhard Okamura¹⁷, Samyut Shrestha¹⁷, Philip Haaf¹⁷, Patrick Badertscher¹⁷, Joan Elias Walter¹⁷, Beatriz López¹⁹, Gemma Martinez-Nadal¹⁹, Esther Rodriguez Adrada²⁰, Jiri Parenica²¹, Arnold von Eckardstein²², Beata Morawiec²³, Piotr Muzyk²³, Henrik Schirmer²⁴

Affiliations

¹ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: luca.koechlin@usb.ch.
² Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.
³ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy.
⁴ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
⁵ GREAT Network, Rome, Italy; Emergency Department, Hospital Clínic, Barcelona, Spain.
⁶ GREAT Network, Rome, Italy; Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain.
⁷ GREAT Network, Rome, Italy; 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland.
⁸ Emergency Department, University Hospital Zurich, Zurich, Switzerland.
⁹ Emergency Department, Kantonsspital Luzern, Lucerne, Switzerland.
¹⁰ Department of Hematology and Blood Bank, University Hospital Basel, University of Basel, Basel, Switzerland.
¹¹ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; Department of Cardiology, University Hospital Valencia, Valencia, Spain.
¹² SpinChip Diagnostics, Oslo, Norway.
¹³ K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.
¹⁴ K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway; Akershus Clinical Research Center, Division of Research and Innovation, Akershus University Hospital, Lørenskog, Norway.
¹⁵ K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Akershus Clinical Research Center, Division of Research and Innovation, Akershus University Hospital, Lørenskog, Norway.
¹⁶ Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: christian.mueller@usb.ch.
¹⁷ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel; GREAT network.
¹⁸ Blood Transfusion Centre, Swiss Red Cross, Basel, Switzerland and Department of Hematology, University Hospital Basel, University of Basel, Switzerland.
¹⁹ GREAT network; Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain.
²⁰ Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain.
²¹ Department of Cardiology, University Hospital Brno, Brno, Czech Republic and Medical Faculty, Masaryk University, Brno, Czech Republic.
²² Emergency Department of Laboratory Medicine, University Hospital Zurich, Switzerland.
²³ GREAT network; 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Poland.
²⁴ K. G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.

PMID: 39142727
DOI: 10.1016/j.jacc.2024.05.056

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).

Keywords: acute coronary syndrome; biomarker; myocardial infarction; troponin.

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Conflict of interest statement

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.

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

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Associated data

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