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

Luca Koechlin; Jasper Boeddinghaus; Pedro Lopez-Ayala; Cornelia Reber; Thomas Nestelberger; Karin Wildi; Carlos C Spagnuolo; Ivo Strebel; Jonas Glaeser; Paolo Bima; Luca Crisanti; Lourdes Herraiz-Recuenco; Elisa Dubach; Òscar Miró; F Javier Martin-Sanchez; Damian Kawecki; Dagmar I Keller; Michael Christ; Andreas Buser; Maria Rubini Giménez; Gro Leite Størvold; Marianne Nordlund Broughton; Torbjørn Omland; Magnus N Lyngbakken; Helge Røsjø; Christian Mueller; APACE Investigators

doi:10.1016/j.jacc.2024.05.056

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

J Am Coll Cardiol. 2024 Aug 20;84(8):726-740. doi: 10.1016/j.jacc.2024.05.056.

Authors

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

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: [email protected].
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: [email protected].
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.

Publication types

Multicenter Study

MeSH terms

Aged
Biomarkers / blood
Female
Humans
Male
Middle Aged
Myocardial Infarction* / blood
Myocardial Infarction* / diagnosis
Point-of-Care Systems
Prospective Studies
Sensitivity and Specificity
Troponin I* / blood

Substances

Troponin I
Biomarkers

Associated data

ClinicalTrials.gov/NCT00470587