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

L. Koechlin, J. Boeddinghaus, P. Lopez-Ayala, C. Reber, T. Nestelberger, K. Wildi, CC. Spagnuolo, I. Strebel, J. Glaeser, P. Bima, L. Crisanti, L. Herraiz-Recuenco, E. Dubach, Ò. Miró, FJ. Martin-Sanchez, D. Kawecki, DI. Keller, M. Christ, A....

. 2024 ; 84 (8) : 726-740. [pub] 20240820

Language English Country United States

Document type Journal Article, Multicenter Study

Persistent link   https://www.medvik.cz/link/bmc24019307

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).

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$a Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay / $c L. Koechlin, J. Boeddinghaus, P. Lopez-Ayala, C. Reber, T. Nestelberger, K. Wildi, CC. Spagnuolo, I. Strebel, J. Glaeser, P. Bima, L. Crisanti, L. Herraiz-Recuenco, E. Dubach, Ò. Miró, FJ. Martin-Sanchez, D. Kawecki, DI. Keller, M. Christ, A. Buser, MR. Giménez, GL. Størvold, MN. Broughton, T. Omland, MN. Lyngbakken, H. Røsjø, C. Mueller, APACE Investigators
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$a 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).
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$a Boeddinghaus, Jasper $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom
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$a Lopez-Ayala, Pedro $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Reber, Cornelia $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland
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$a Nestelberger, Thomas $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Wildi, Karin $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Spagnuolo, Carlos C $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Strebel, Ivo $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Glaeser, Jonas $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Bima, Paolo $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Crisanti, Luca $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Herraiz-Recuenco, Lourdes $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy
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$a Dubach, Elisa $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland
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$a Miró, Òscar $u GREAT Network, Rome, Italy; Emergency Department, Hospital Clínic, Barcelona, Spain
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$a Martin-Sanchez, F Javier $u GREAT Network, Rome, Italy; Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain
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$a Kawecki, Damian $u GREAT Network, Rome, Italy; 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland
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$a Keller, Dagmar I $u Emergency Department, University Hospital Zurich, Zurich, Switzerland
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$a Christ, Michael $u Emergency Department, Kantonsspital Luzern, Lucerne, Switzerland
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$a Buser, Andreas $u Department of Hematology and Blood Bank, University Hospital Basel, University of Basel, Basel, Switzerland
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$a Giménez, Maria Rubini $u Cardiovascular Research Institute Basel, and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; Department of Cardiology, University Hospital Valencia, Valencia, Spain
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$a Størvold, Gro Leite $u SpinChip Diagnostics, Oslo, Norway
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$a Broughton, Marianne Nordlund $u SpinChip Diagnostics, Oslo, Norway
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$a Omland, Torbjørn $u K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway
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$a Lyngbakken, Magnus N $u K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway; Akershus Clinical Research Center, Division of Research and Innovation, Akershus University Hospital, Lørenskog, Norway
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$a Røsjø, Helge $u K.G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Akershus Clinical Research Center, Division of Research and Innovation, Akershus University Hospital, Lørenskog, Norway
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$a Mueller, Christian $u 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
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