High-sensitivity cardiac troponin t concentrations below the limit of detection to exclude acute myocardial infarction: a prospective evaluation.

Abstract

BACKGROUND:

Initial reports suggest that concentrations of high-sensitivity cardiac troponin T (hs-cTnT) (Roche Diagnostics Elecsys(®)) below the limit of blank (LoB) (3 ng/L) or limit of detection (LoD) (5 ng/L) of the assay have almost 100% negative predictive value (NPV) for acute myocardial infarction (AMI), particularly among patients without electrocardiograph (ECG) evidence of ischemia. We aimed to prospectively validate those findings.

METHODS:

We included adults presenting to the emergency department with suspected cardiac chest pain. Standard troponin T (cTnT) and hs-cTnT (both Roche Elecsys) were tested in samples drawn on arrival. The primary outcome was AMI, adjudicated by 2 investigators on the basis of clinical data and ≥12-h cTnT testing. We also evaluated diagnostic performance when AMI was readjudicated on the basis of hs-cTnT (≥12-h) concentrations.

RESULTS:

Of 463 patients included, 79 (17.1%) had AMI. Twenty-four patients (5.2%) had hs-cTnT concentrations below the LoB, although none had AMI. Ninety-six patients (20.7%) had hs-cTnT concentrations below the LoD, 1 of whom had AMI. Thus, diagnostic sensitivity was 98.7% (95% CI 87.5%-98.6%) and NPV was 99.0% (95% CI 94.3%-100.0%). Of the 17.3% (n = 80) patients with hs-cTnT below the LoD and no ECG ischemia, none had AMI. Thus, diagnostic sensitivity was 100.0% (95% CI 95.4%-100.0%) and NPV was 100.0% (95% CI 95.5%-100.0%). Sensitivity and NPV were maintained when AMI was readjudicated on the basis of hs-cTnT.

CONCLUSIONS:

Our findings confirm that patients with nonischemic ECG and undetectable hs-cTnT at presentation have a very low probability of AMI, although the proportion of patients affected was smaller than in previous research.

• Authors: Richard Body, Gillian Burrows, Simon Carley, Louise Cullen, Martin Than, Allan S Jaffe, Philip S Lewis
• Journal: Clinical chemistry (Clin Chem) Vol. 61 Issue 7 Pg. 983-9 (Jul 2015) ISSN: 1530-8561 [Electronic] England
• PMID: 25979953 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 American Association for Clinical Chemistry.

Chemical References

• Biomarkers
• Troponin T

Topics

• Acute Disease
• Aged
• Biomarkers (blood)
• Chest Pain (diagnosis)
• Electrocardiography
• Female
• Humans
• Length of Stay
• Limit of Detection
• Male
• Middle Aged
• Myocardial Infarction (blood, diagnosis)
• Predictive Value of Tests
• Prospective Studies
• ROC Curve
• Sensitivity and Specificity
• Troponin T (blood)