Bridging High-Sensitivity and Point-of-Care Troponin Testing: IFCC Practice Recommendations
This IFCC Committee review addresses the implementation of high-sensitivity and point-of-care cardiac troponin assays, incorporating updates from the Fourth Universal Definition of Myocardial Infarction. Key topics include new IFCC/AACC laboratory practice recommendations, regulatory challenges for point-of-care assay clearance, and the role of troponin testing during COVID-19. Providing high-sensitivity POC troponin assays and optimizing regulatory pathways for their approval may significantly improve patient management and outcomes in time-critical settings.
The original study
Implementation of High-Sensitivity and Point-of-Care Cardiac Troponin Assays into Practice: Some Different Thoughts.
- Authors
- Apple FS, Fantz CR, Collinson PO
- Journal
- Clinical chemistry
- Type
- Journal Article, Review
- PMID
- 33279984
Original abstract
BACKGROUND: The primary role of the International Federation of Clinical Chemistry (IFCC) Committee on Clinical Application of Cardiac Bio-Markers (C-CB) is to provide educational materials about cardiac biomarker use, emphasizing high-sensitivity cardiac troponin assays. CONTENT: This mini-review, regarding high-sensitivity cardiac and point-of-care troponin assays, addresses 1) new IFCC C-CB/AACC Academy laboratory practice recommendations; 2) new and updated concepts from the Fourth Universal Definition of Myocardial Infarction; 3) the role of point-of-care assays in practice and research; 4) regulatory challenges concerning point-of-care assays; e) testing in the COVID-19 world. SUMMARY: Implementation of high-sensitivity cardiac troponin assays makes a difference now and into the future in clinical practice and research. Providing point-of-care high-sensitivity cardiac troponin assays and optimizing studies to allow clearance of these assays by regulatory agencies, in a timely fashion, may provide improved patient management and outcomes.