0/2 h-Algorithm for Rapid Triage of Suspected Myocardial Infarction Using a Novel High-Sensitivity Cardiac Troponin I Assay

• Published in: Clinical chemistry (Baltimore, Md.) Vol. 68; no. 2; pp. 303 - 312
• Main Authors: Wildi, Karin, Boeddinghaus, Jasper, Nestelberger, Thomas, Lopez-Ayala, Pedro, Yufera Sanchez, Ana, Okamura, Bernhard, Shrestha, Samyut, Rohner, Jennifer, Miró, Òscar, Martinez-Nadal, Gemma, Martin-Sanchez, F Javier, Koechlin, Luca, Twerenbold, Raphael, Christ, Michael, Kawecki, Damian, Rubini Giménez, Maria, Keller, Dagmar I, Mueller, Christian, Wussler, Desiree, Strebel, Ivo, Bakula, Adam, Frey, Simon, Gualandro, Danielle M, Zimmermann, Tobias, Puelacher, Christian, du Fay de Lavallaz, Jeanne, Potlukova, Eliska, Diebold, Matthias, Geigy, Nicolas, Rentsch, Katharina, Mitrovic, Sandra, Fuenzalida, Carolina, Glarner, Noemi, Morawiec, Beata, Breidthardt, Tobias, Freese, Michael, López, Beatriz, Calderón, Sofia, Adrada, Esther Rodriguez, Ganovská, Eva, Parenica, Jiri, von Eckardstein, Arnold, Campodarve, Isabel, Gea, Joaquim
• Format: Journal Article
• Language: English
• Published: Washington Oxford University Press 01.02.2022
• Subjects: Algorithms; Assaying; Calcium-binding protein; Chest; Confidence intervals; Derivation; Diagnosis; Emergency medical care; Emergency medical services; Heart; Heart attack; Heart attacks; Mathematical models; Medical diagnosis; Myocardial infarction; Pain; Patients; Physiological aspects; Reagents; Sensitivity; Thresholds; Troponin; Troponin I; Spain
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1093/clinchem/hvab203

Abstract Background We aimed to derive and validate a 0/2 h-algorithm using the new high-sensitivity cardiac troponin I (hs-cTnI)-VITROS assay (VITROS® Immunodiagnostic Products hs-Troponin I Reagent Pack, Ortho Clinical Diagnostics) for rapid rule-out/in of non-ST-segment elevation myocardial infarction (NSTEMI). Methods The final diagnosis was centrally adjudicated by 2 independent cardiologists according to the fourth universal definition of myocardial infarction (MI) among 1888 patients presenting to the emergency department with acute chest pain. hs-cTnI-VITROS concentrations were measured at presentation and at 2 h in a blinded fashion. The optimal assay-specific thresholds for the hs-cTnI-VITROS 0/2 h-algorithm were derived in a randomly selected 70% of the cohort and validated in the remaining 30%. Results NSTEMI was the final diagnosis in 216/1322 (16.3%) patients of the derivation cohort. Rule-out was defined as baseline hs-cTnI concentrations of <1 ng/L in patients presenting with chest pain onset >3 h or a baseline hs-cTnI concentration of <2 ng/L and an absolute change of <3 ng/L within 2 h. Thresholds for rule-in were either ≥40 ng/L at presentation or an absolute change within 2 h of ≥ 5ng/L. In the derivation cohort, these thresholds ruled-out 50.8% of patients with a negative predictive value (NPV) and sensitivity of 99.7% (95% Confidence Interval (CI), 98.8–99.9%) and 99.1% (95% CI, 96.7–99.9%), and ruled-in 17.9% with a positive predictive value (PPV) of 79.2% (95% CI, 74.3–83.5%). In the validation cohort, NSTEMI was the final diagnosis in 91/566 (16.1%) patients. The derived 0/2 h-algorithm ruled-out 46.3% of patients with a NPV and sensitivity of 100% (95% CI, 95.6–100%) and 100% (95% CI, 96.0–100%), and ruled-in 18.9% with a PPV of 73.8% (95% CI, 66.1–80.3%) in the validation cohort. Conclusion hs-cTnI-VITROS concentrations at presentation combined with absolute changes within the first 2 h allowed safe rule-out and accurate rule-in of NSTEMI in two-thirds of unselected patients presenting with acute chest pain to the emergency department. Trial registration www.clinicaltrials.gov: NCT0047058