Use of Troponin Assay 99th Percentile as the Decision Level for Myocardial Infarction Diagnosis

• Published in: The American heart journal Vol. 190; pp. 135 - 139
• Main Authors: Bagai, Akshay, MD, MHS, Alexander, Karen P., MD, Berger, Jeffrey S., MD, MS, Senior, Roxy, MD, DM, Sajeev, Chakkanalil, MD, DM, PhD, Pracon, Radoslaw, MD, PhD, Mavromatis, Kreton, MD, Lopez-Sendón, Jose Luis, MD, PhD, Gosselin, Gilbert, MD, CM, Diaz, Ariel, MSc, MD, Perna, Gian, MD, Drozdz, Jarozlaw, MD, Humen, Dennis, MD, Petrauskiene, Birute, PhD, Cheema, Asim N., MD, PhD, Phaneuf, Denis, MD, Banerjee, Subhash, MD, Miller, Todd D., MD, Kedev, Sasko, MD, PhD, Schuchlenz, Herwig, MD, Stone, Gregg W., MD, Goodman, Shaun G., MD, MSc, Mahaffey, Kenneth W., MD, Jaffe, Allan S., MD, Rosenberg, Yves D., MD, MPH, Bangalore, Sripal, MD, MHA, Newby, L. Kristin, MD, MHS, Maron, David J., MD, Hochman, Judith S., MD, Chaitman, Bernard R., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-08-2017; Elsevier Limited
• Subjects: Acute coronary syndromes; Adjudication; Assaying; Biomarkers; Biomarkers - blood; Calcium-binding protein; Cardiology; Cardiovascular; Clinical outcomes; Clinical trials; Diagnosis; Electrocardiography; Heart; Heart attacks; Heart diseases; Humans; Laboratories; Lungs; Medical diagnosis; Medical research; Myocardial infarction; Myocardial Infarction - blood; Myocardial Infarction - diagnosis; Pain; Patients; Retrospective Studies; Troponin; Troponin - blood; United States; Variability; United States > US
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2017.04.016

Background The Universal Definition of Myocardial Infarction recommends the 99th percentile concentration of cardiac troponin in a normal reference population as part of the decision threshold to diagnose type 1 spontaneous myocardial infarction. Adoption of this recommendation in contemporary worldwide practice is not well known. Methods We performed a cohort study of 276 hospital laboratories in 31 countries participating in the National Heart, Lung, and Blood Institute sponsored International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial. Each hospital laboratory's troponin assay manufacturer and model, the recommended assay's 99th percentile upper reference limit (URL) from the manufacturer's package insert, and the troponin concentration used locally as the decision level to diagnose myocardial infarction was ascertained. Results Twenty-one unique troponin assays from 9 manufacturers were used by the surveyed hospital laboratories. The ratio of the troponin concentration used locally to diagnose myocardial infarction to the assay manufacturer-determined 99th percentile URL was <1 at 19 (6.6%) laboratories, equal to 1 at 91 (31.6%) laboratories, >1 to ≤5 at 101 (35.1%) laboratories, >5 to ≤10 at 34 (11.8%) laboratories and >10 at 43 (14.9%) laboratories. The variability in troponin decision level for myocardial infarction relative to the assay 99th percentile URL was present for laboratories in and outside of the United States, as well as for high- and standard-sensitivity assays. Conclusions There is substantial hospital level variation in the troponin threshold used to diagnose myocardial infarction; only one-third of hospital laboratories currently follow the Universal Definition of Myocardial Infarction consensus recommendation for use of troponin concentration at the 99th percentile of a normal reference population as the decision level to diagnose myocardial infarction. This variability across laboratories has important implications both for the diagnosis of myocardial infarction in clinical practice as well as adjudication of myocardial infarction in clinical trials.