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).

Cardiovascular Research Institute Basel and Department of Cardiology University Hospital Basel University of Basel Basel Switzerland

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

Cardiovascular Research Institute Basel and Department of Cardiology University Hospital Basel University of Basel Basel Switzerland; Department of Cardiology University Hospital Valencia Valencia Spain

Cardiovascular Research Institute Basel and Department of Cardiology University Hospital Basel University of Basel Basel Switzerland; GREAT Network Rome Italy

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

Department of Hematology and Blood Bank University Hospital Basel University of Basel Basel Switzerland

Emergency Department Kantonsspital Luzern Lucerne Switzerland

Emergency Department University Hospital Zurich Zurich Switzerland

GREAT Network Rome Italy; 2nd Department of Cardiology School of Medicine with the Division of Dentistry in Zabrze Medical University of Katowice Katowice Poland

GREAT Network Rome Italy; Emergency Department Hospital Clínic Barcelona Spain

GREAT Network Rome Italy; Servicio de Urgencias Hospital Clínico San Carlos Madrid Spain

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

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

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

SpinChip Diagnostics Oslo Norway

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ClinicalTrials.gov
NCT00470587