# Analytical and Clinical Performance of High-Sensitivity Cardiac Troponin Point-of-Care Assays as an Aid in the Diagnosis of Myocardial Infarction: A Narrative Review

## TL;DR

This review evaluates high-sensitivity cardiac troponin point-of-care tests for diagnosing heart attacks, showing they perform as well as lab tests and can speed up diagnosis.

## Contribution

The paper provides a comprehensive overview of currently available and developing point-of-care hs-cTn assays and their performance in diagnosing myocardial infarction.

## Key findings

- Seven POC hs-cTn assays are currently FDA or CE-approved, with four more under development.
- Clinical performance of POC assays aligns with ESC guidelines, with sensitivity and negative predictive values exceeding 99%.
- POC assays show no significant differences in diagnostic accuracy compared to traditional lab-based tests.

## Abstract

Acute coronary syndrome (ACS) poses a significant burden worldwide; however, the development of high-sensitivity cardiac troponin (hs-cTn) assays has greatly improved patient management by enabling the detection of very low levels of troponin. The objective of this review was to identify current hs-cTn point-of-care (POC) assays, describe their key features, and discuss their analytical and clinical performance.

PubMed, MEDLINE, and Embase databases, as well as relevant web sources, were searched for publications up to April 10, 2025. The references included describe the main characteristics of POC hs-cTn assays and their companion instruments, as well as studies assessing their analytical or clinical performance in the context of acute myocardial infarction diagnosis.

In addition to information publicly available from the web, 27 publications were considered relevant for this review. From the retrieved sources, seven POC hs-cTn assays were identified as currently cleared by the United States Food and Drug Administration or CE-marked. Four additional POC hs-cTn assays, each evaluated for analytical or clinical performance, were identified as currently or previously under development. POC instruments differ in their key characteristics, many of which are crucial for ensuring their suitability in specific clinical settings and intended applications. Despite some variability in performance across different platforms, they are generally consistent with the high-sensitivity profile expected of cTn assays. Clinical performance indicators for hs-cTn assays align with European Society of Cardiology (ESC) recommendations, particularly when ESC-recommended diagnostic algorithms are applied. Reported sensitivity and negative predictive values exceed 99%, while positive predictive values are above 70%. Moreover, comparative studies of POC hs-cTn assays and laboratory-based hs-cTn tests have demonstrated no significant differences in diagnostic accuracy for ruling in or ruling out acute myocardial infarction.

POC hs-cTn assays represent a promising alternative to traditional laboratory testing, providing similar analytical and clinical performance while enabling faster diagnosis and management of ACS. Expanded use of hs-cTn assays in clinical practice could transform patient care pathways, especially in time-critical situations. Continued research and ongoing technological advancements are critical to ensure optimal use and widespread adoption in routine clinical settings.