Testing of cardiac biomarkers, such as cardiac troponin I or cardiac troponin T, has an important role in the diagnostic workup for acute coronary syndrome (ACS) (including acute myocardial infarction [AMI] and unstable angina), and in patients presenting with acute chest pain and a non-diagnostic electrocardiogram (ECG). Bedside testing of cardiac troponins (cTn) using point-of-care (POC) assays was developed to reduce the turnaround time of the standard tests performed in a central laboratory, and to expedite treatment. Given the introduction and increasing diffusion of POC cTn use, a review of its clinical and economic evidence is needed to inform decisions about its acquisition and use in emergency rooms and other in-hospital settings, as well as in rural health care centres and remote settings.

Contents

• External Reviewers
• Authorship
• Acknowledgements
• Conflicts of Interest
• Abbreviations
• EXECUTIVE SUMMARY
• 1. Introduction
  • 1.1 Chest Pain and Acute Coronary Syndrome
  • 1.2 Cardiac Troponin Testing
  • 1.3 Point-of-Care Cardiac Troponin Testing
  • 1.4 Decision-Making About Point-of-Care Troponin Testing
• 2. Objectives
  • 2.1 Research Questions
• 3. Clinical Review
  • 3.1 Clinical Review Methods
• 4. Clinical Results
  • 4.1 Literature Search Results
  • 4.2 Study and Patient Characteristics
  • 4.3 Results of Critical Appraisal
  • 4.4 Diagnostic Accuracy
  • 4.5 Clinical-Utility Results
  • 4.6 Clinical-Utility Results
  • 4.7 Guidelines
• 5. Clinical Discussion
  • 5.1 Diagnostic Test Accuracy
  • 5.2 Clinical Utility in Settings With a Central Laboratory
  • 5.3 Clinical Utility in Settings With No Central Laboratory
• 6. Economic Review
  • 6.1 Economic Methods
  • 6.2 Strategies
  • 6.3 Perspective
  • 6.4 Time Horizon
  • 6.5 Effectiveness
  • 6.6 Decision Analytic Model
  • 6.7 Valuing Outcomes
  • 6.8 Cost Estimates and Resource Utilization
  • 6.9 Variability and Uncertainty
  • 6.10 Cost-Consequence Table
• 7. Economic Results
  • 7.1 Base-Case Results
  • 7.2 Variability and Uncertainty
  • 7.3 Scenario Analysis for Diagnostic Accuracy
  • 7.4 Cost and Consequence Tables
• 8. Economic Discussion
• 9. Clinical And Economic Review Limitations
• 10. Conclusions
• References
• Appendix 1 Point-of-Care Troponin Devices
• Appendix 2 Literature Search Strategy
• Appendix 3 Flow Chart of Included Studies
• Appendix 4 List of Included Diagnostic Accuracy and Clinical-Utility Studies
• Appendix 5 List of Excluded Studies
• Appendix 6 Study Characteristics
• Appendix 7 Patient Characteristics
• Appendix 8 Critical Appraisal
• Appendix 9 Diagnostic Accuracy
• Appendix 10 Clinical Utility
• Appendix 11 Schematics for the Economic Models
• Appendix 12 Summary Receiver Operating Characteristic Curve for the Pooled Diagnostic Accuracy of POC cTn Devices

About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system.

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec. Views: The views expressed herein are those of CADTH and do not necessarily reflect the views of our funders.

Suggested citation:

Point-of-Care Troponin Testing in Patients With Symptoms Suggestive of Acute Coronary Syndrome: A Health Technology Assessment. Ottawa: CADTH; 2016 Mar. (CADTH optimal use report; vol.5, no.1b).

This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). This report contains a comprehensive review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) available to CADTH at the time it was prepared, and it was guided by expert input and advice throughout its preparation.

The information in this report is intended to help health care decision-makers, patients, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment in respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this report to ensure that its contents are accurate, complete, and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or as a result of the use (or misuse) of any information contained in or implied by the information in this report.

CADTH takes sole responsibility for the final form and content of this report. The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any provincial or territorial government.

Production of this report is made possible through a financial contribution from Health Canada.

PROSPERO Registration Number: CRD42015023442