Diagnostic performance of high sensitivity compared with contemporary cardiac troponin I for the diagnosis of acute myocardial infarction

Yader Sandoval, Stephen W. Smith, Sarah E. Thordsen, Charles A. Bruen, Michelle D. Carlson, Kenneth W. Dodd, Brian E. Driver, Katherine Jacoby, Benjamin K. Johnson, Sara A. Love, Johanna C. Moore, Anne Sexter, Karen Schulz, Nathaniel L. Scott, Jennifer Nicholson, Fred S. Apple

Research output: Contribution to journalArticlepeer-review

16 Scopus citations

Abstract

BACKGROUND: We examined the diagnostic performance of high-sensitivity cardiac troponin I (hs-cTnI) vs contemporary cTnI with use of the 99th percentile alone and with a normal electrocardiogram (ECG) to rule out acute myocardial infarction (MI) and serial changes (deltas) to rule in MI. METHODS: We included consecutive patients presenting to a US emergency department with serial cTnI on clinical indication. Diagnostic performance for acute MI, including MI subtypes, and 30-day outcomes were examined. RESULTS: Among 1631 patients, MI was diagnosed in 12.9% using the contemporary cTnI assay and in 10.4% using the hs-cTnI assay. For ruling out MI, contemporary cTnI≤99th percentile at 0, 3, and 6 h and a normal ECG had a negative predictive value (NPV) of 99.5% (95% CI, 98.6 -100) and a sensitivity of 99.1% (95% CI, 97.4 -100) for diagnostic and safety outcomes. Serial hscTnI measurements ≤99th percentile at 0 and 3 h and a normal ECG had an NPV and sensitivity of 100% (95% CI, 100-100) for diagnostic and safety outcomes. For ruling in MI, contemporary cTnI measurements had specificities of 84.4% (95% CI, 82.5- 86.3) at presentation and 78.7% (95% CI, 75.4-82.0) with serial testing at 0, 3, and 6 h, improving to 89.2% (95% CI, 87.1- 91.3) by using serial cTnI changes (delta, 0 and 6 h) >150%. hs-cTnI had specificities of 86.9% (95% CI, 85.1- 88.6) at presentation and 85.7% (95% CI, 83.5- 87.9) with serial testing at 0 and 3 h, improving to 89.3% (95% CI, 87.3-91.2) using a delta hs-cTnI (0 and 3 h) >5 ng/L. CONCLUSIONS: hs-cTnI and contemporary cTnI assays are excellent in ruling out MI following recommendations predicated on serial testing and the 99th percentile with a normal ECG. For ruling in MI, deltas improve the specificity.

Original languageEnglish (US)
Pages (from-to)1594-1604
Number of pages11
JournalClinical chemistry
Volume63
Issue number10
DOIs
StatePublished - Oct 2017

Bibliographical note

Funding Information:
Employment or Leadership: F.S. Apple, HyTest Ltd. and Clinical Chemistry, AACC. Consultant or Advisory Role: Y. Sandoval, Roche Diagnostics; S.W. Smith, Alere, Roche Clinical Diagnostics, Siemens; F.S. Apple, Philips Healthcare Incubator, Metanomics Healthcare. Stock Ownership: None declared. Honoraria: F.S. Apple, Instrumentation Laboratory, Abbott POC. Research Funding: UTROPIA study (NCT02060760) partially funded through a grant from Abbott Diagnostics and the Minneapolis Medical Research Foundation. S.A. Love, Research PI through Minneapolis Medical Research Foundation (MMRF), not salaried, and Biokit, Hytest Ltd., Instrumentation Laboratory; F.S. Apple, Re- search PI through Minneapolis Medical Research Foundation (MMRF), not salaried: Abbott Diagnostics, Roche Diagnostics, Siemens Healthcare, Alere, Ortho-Clinical Diagnostics, Nanomix, Becton Dickinson, Singulex. Expert Testimony: None declared.

Publisher Copyright:
© 2017 American Association for Clinical Chemistry.

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