Clinical use of high-sensitivity cardiac troponin for early diagnosis of myocardial infarction and the potential impact of the US FDA regulatory approach

Description

Early and accurate diagnosis of myocardial infarction (MI) is a prerequisite for the timely initiation of life-saving treatment. The first high-sensitivity cardiac troponin (hs-cTn) assays were approved by the U.S. Food and Drug Administration (FDA) as early as 2017. These more sensitive assays have been used clinically in Europe, Australia, Canada, and other countries for several years due to their diagnostic superiority over conventional cTn assays. However, the US FDA-approved use of hs-cTn differs from the contemporary use of hs-cTn in most other countries in two important details. First, in the US very low concentrations are only reported down to the limit of quantification (LoQ) compared with the European standard of reporting the limit of detection (LoD) to clinicians. Second, for certain hs-cTn assays the FDA-approved 99th percentile upper reference limit is slightly higher concentration. Both differences impact the threshold for reporting hs-cTn to clinicians.

In this webinar, Dr. Luca Koechlin will provide an overview of the applications of hs-cTn in early diagnosis of MI. Dr. Luca Koechlin will also compare the approved applications within the US and beyond and the potential impact of differences in MI diagnosis and patient outcomes. As a frequently used and relied on assay, these differences are important to understand for laboratorians and clinicians in the U.S. when using hs-cTn assays.

Target audience

This activity is designed for physicians, advanced practice professionals (NPs, PAs, RNs, etc.), lab supervisors, lab directors (and/or assistant directors), lab managers (supervisory and/or non-supervisory), medical technologists, point-of-care coordinators, pathologists, and in-training individuals.

Learning objectives

At the end of this session, participants will be able to:

• Recognize the importance of hs-cTn assays for the early diagnosis of myocardial infarction.
• Describe the differences in using hs-cTn assays in the US FDA-approved setting compared to their use in Europe, Australia, and Canada.
• Recall the latest evidence on hs-cTn assays, including point-of-care assays, for the early diagnosis of myocardial infarction.

Faculty

Luca Koechlin, MD
Consultant, Department of Cardiac Surgery
Senior Research Fellow, Cardiovascular Research Institute Basel (CRIB)
University Hospital Basel
Basel, Switzerland

Disclosures and statement of independence

The Association for Diagnostics & Laboratory Medicine (formerly AACC) is dedicated to ensuring balance, independence, objectivity, and scientific rigor in all educational activities. All participating planning committee members and faculty are required to disclose to the program audience any financial relationships related to the subject matter of this program. Disclosure information is reviewed in advance in order to manage and resolve any possible conflicts of interest. The intent of this disclosure is to provide participants with information on which they can make their own judgments.

The following faculty reported financial relationships:

• Luca Koechlin, MD
  • Honorarium/Expenses: Polymedco, Roche Diagnostics, Abbott, Siemens Healthineers
  • Grant/Research Support: Swiss Heart Foundation, the University of Basel, the Swiss Academy of Medical Sciences and the Gottfried, Julia Bangerter-Rhyner Foundation, Freiwillige Akademische Gesellschaft Basel

Content validity

All recommendations involving clinical medicine are based on evidence accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients; AND/OR all scientific research referred to or reported in support or justification of a patient care recommendation conforms to generally accepted standards of experimental design, data collection, and analysis.

Accreditation statement

This activity is approved for 1.0 ACCENT® continuing education credits. Activity ID #4376. This activity was planned in accordance with ACCENT® Standards and Policies.

Successful completion statement

Verification of Participation certificates are provided to registered participants based on completion of the activity, in its entirety, and the activity evaluation. For questions regarding continuing education, please email [email protected].