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Single test rule-out of acute myocardial infarction using the limit of detection of a new high-sensitivity troponin I assay.

Body, R; Morris, N; Collinson, P (2020) Single test rule-out of acute myocardial infarction using the limit of detection of a new high-sensitivity troponin I assay. Clin Biochem, 78. pp. 4-9. ISSN 1873-2933 https://doi.org/10.1016/j.clinbiochem.2020.02.014
SGUL Authors: Collinson, Paul

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Abstract

OBJECTIVES: To determine the diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay in patients presenting to the Emergency Department (ED) with suspected acute coronary syndromes. Specifically, we evaluated the use of a single blood test at the time of arrival in the ED, using low hs-cTnI cut-offs. METHODS: In a prospective diagnostic test accuracy study at 14 centers, we included patients presenting to the ED with suspected ACS within 12 h of symptom onset. We drew blood for hs-cTnI (Siemens ADVIA Centaur, overall 99th percentile 47 ng/L, limit of quantification [LoQ] 2.50 ng/L) on arrival. Patients underwent serial cardiac troponin testing over 3-6 h. The primary outcome was an adjudicated diagnosis of acute myocardial infarction (AMI). We evaluated the incidence of major adverse cardiac events (MACE: death, AMI or revascularization) after 30 days. Test characteristics for hs-cTnI were calculated using previously reported cut-offs set at the LoQ and 5 ng/L. RESULTS: We included 999 patients, including 131 (13.1%) with an adjudicated diagnosis of AMI. Compared to the LoQ (100.0% sensitivity [95% CI 95.9-100.0%]), 99.7% negative predictive value [NPV; 95% CI 97.6-100.0%]), a 5 ng/L cut-off had slightly lower sensitivity (99.2%; 95% CI 95.8-100.0%) and similar NPV (99.8%; 95% CI 98.6-100.0%) but would rule out more patients (28.6% at the LoQ vs 50.4% at 5 ng/L). MACE occurred in 2 (0.7%) patients with hs-cTnI below the LoQ and 7 (1.4%) patients with hs-cTnI < 5 ng/L. Accounting for time from symptom onset or ECG ischemia did not further improve sensitivity. CONCLUSION: The Siemens ADVIA Centaur hs-cTnI assay has high sensitivity and NPV to rule out AMI with a single blood test in the ED. At the LoQ cut-off a sensitivity > 99% can be achieved. At a 5 ng/L cut-off it may be possible to rule out AMI for over 50% patients.

Item Type: Article
Additional Information: © 2020. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Keywords: Acute coronary syndromes, Cardiac troponin, Clinical decision rules, Sensitivity and specificity, Acute coronary syndromes, Clinical decision rules, Cardiac troponin, Sensitivity and specificity, Acute Coronary Syndromes, Cardiac Troponin, Clinical Decision Rules, Sensitivity and Specificity, 1101 Medical Biochemistry and Metabolomics, General Clinical Medicine
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: Clin Biochem
ISSN: 1873-2933
Language: eng
Dates:
DateEvent
April 2020Published
2 March 2020Published Online
29 February 2020Accepted
Publisher License: Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0
PubMed ID: 32135083
Web of Science ID: WOS:000530714900002
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/112032
Publisher's version: https://doi.org/10.1016/j.clinbiochem.2020.02.014

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