IFCC Framework for Implementing High-Sensitivity Cardiac Troponin Point-of-Care Testing in Acute Care Settings
This IFCC Committee on Clinical Application of Cardiac Bio-Markers educational document provides a pragmatic framework for validating, verifying, and deploying high-sensitivity cardiac troponin point-of-care assays in acute care networks. It delineates manufacturer versus local responsibilities and outlines verification procedures to avoid unnecessary duplication of central laboratory validation work while ensuring reliable clinical performance.
The original study
Considerations and pragmatic strategies for implementation of point of care testing for high sensitivity cardiac troponin into the acute care setting.
- Authors
- Collinson P, Lam L, Pickering JW, Christenson R, Van Hoovels L, Jafri L, et al.
- Journal
- Clinical chemistry and laboratory medicine
- Type
- Journal Article, Review
- PMID
- 41784012
Original abstract
A challenge in the implementation of rapid risk-stratification algorithms for patients with suspected acute coronary syndrome is the turnaround time for cardiac troponin (cTn) from blood sampling to reporting of results. Measurement of cTn in whole blood using point of care (POC) offers a solution. There is lack of consensus on how these instruments should be assessed and deployed when implemented into routine practice. A pragmatic strategy is needed to balance the requirement for appropriate evaluation, validation and local verification of POC high sensitivity (hs) cTn assays whilst avoiding unnecessary duplication of previously conducted work using central laboratory assays. The International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Application of Cardiac Bio-Markers (IFCC C-CB) has developed an educational document to provide practical suggestions as to how hs-cTn POC assays may be implemented in acute health care settings and networks. The objective of this document is to provide a pragmatic framework for implementation of such systems. The article describes the validation and verification procedures and outlines what should be the responsibility of the manufacturers and provides recommendations on how a local verification may be undertaken before instruments are implemented into routine clinical practice.