Implementation of High-Sensitivity and Point-of-Care Cardiac Troponin Assays into Practice: Some Different Thoughts

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.

Rapid Exclusion of Acute Myocardial Injury and Infarction With a Single High-Sensitivity Cardiac Troponin T in the Emergency Department: A Multicenter United States Evaluation

“…Most studies in this field have been designed to exclude acute myocardial infarction rather than myocardial injury. In the United States, however, the LoD cannot be reported for clinical use per the US Food and Drug Administration (FDA) 16,17 despite recent guidelines 1 from the American Heart Association/American College of Cardiology that support this approach to exclude myocardial injury with a class 2a recommendation (level of evidence B, nonrandomized) for patients with suspected acute coronary syndrome with symptom onset at least 3 hours before presentation.…”

Getting Cardiac Troponin Right: Appraisal of the 2020 European Society of Cardiology Guidelines for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation by the International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Applications of Cardiac Bio-Markers

“…For many POC assays, the jump from plasma to whole blood is a substantial challenge. In addition, it does not address analytical performance aspects that might be influenced when non-laboratory staff conduct POC testing (24). We concur with the recent NICE guidelines that until a POC device is appropriately validated using whole blood it should not be designated as hs-cTn POC assay (25).…”

Prefab Hollow Glass Microsphere-Based Immunosensor with Liquid Crystal Sensitization for Acute Myocardial Infarction Biomarker Detection

“…In addition to traditional immunoassays, the convenient use of biosensors to assess the cTn concentration has become one of the most expectant diagnostic tools for AMI prediction [ 10 ]. At present, electrochemical (ELC) [ 11 ], field-effect transistor (FET) [ 12 ], lateral flow immunoassay (LFIA) [ 13 ], and optical fiber [ 14 , 15 , 16 , 17 , 18 ] biosensors are attractive for point-of-care testing (POCT) [ 19 ], which facilitate a whole new horizon for possible treatment and prevention of cardiovascular diseases. With the development of materials and manufacturing technologies, optical fiber biosensors in particular have been exploited for cTn assays in recent years owing to their fiber waveguide structure and biocompatible silica materials.…”