How to choose a point‐of‐care testing for troponin

Abstract

Background Point‐of‐care (POC) cTn assays are needed when the central laboratory is unable to provide timely results to the emergency department. Many POC devices are available. The prospect of choosing them is daunting. In order to provide a quick decision‐making reference for POC cTn device selection comparing them to the central laboratory, seven POC devices commonly employed by emergency department were evaluated. Methods Firstly, we reviewed all devices package inserts. Secondly, we evaluated several POC cTn assays for imprecision, linearity, and correlation with central laboratory assays according to CLSI EP protocols. The linear regression analyses were performed only for the detectable concentrations. Five cTnI devices (Alere Triage, BioMerieux Vidas, Mitsubishi Pathfast, ReLIA TZ‐301, and Radiometer AQT90) were evaluated against a contemporary cTnI assay (Beckman Access II Accu TnI). Two cTnT assays (Radiometer AQT90 and Roche Cobas h232) were compared to a high‐sensitivity (hs) cTnT method (Roche Cobas e601). Results For cTn levels around the 99th percentile upper reference limits (URLs) of the comparator assays, imprecision could not be assessed for the Alere, BioMerieux, and Cobas h232 as they gave undetectable readings due to a lack of assay sensitivity. Imprecision (CV) was unacceptably high for the ReLIA (33.3%). On account of this precision metric, these four assays were deemed unsuitable. Regression analyses showed acceptable linearity for all the POC devices. The correlation coefficients for ReLIA, BioMerieux, Cobas h232, and Radiometer cTnT were >0.95. Unlike the cTnT devices, the cTnI assays employ different capture and detection antibodies leading to non‐commutable results. The POC cTn results were concordant with their comparator—Radiometer cTnT 90%, Pathfast cTnI 85%, and Radiometer cTnI 75%. Conclusion Our study provides the procedure and essential data to guide selection of a POC cTn device. Of the point‐of‐care devices, methods evaluated Radiometer AQT90 (cTnI and cTnT) and Pathfast might be considered.

Development of Nucleic‐Acid‐Based Electrochemical Biosensors for Clinical Applications

“…Biomarkers are also widely used in the management of cardiovascular diseases by providing diagnosis, disease process definition, risk stratification, and treatment selection and monitoring [190] . There are a number of commercial immunoassays, [191–203] some based on electrochemical readout and antibody probes, [204] for the monitoring of cardiac biomarkers such as troponin, brain type natriuretic peptide (BNP), pro‐hormone BNP (pro‐BNP), and N‐terminal pro‐hormone BNP (NT pro‐BNP) [204–206] …”

“…Biomarkers are also widely used in the management of cardiovascular diseases by providing diagnosis, disease process definition, risk stratification, and treatment selection and monitoring. [190] There are a number of commercial immunoassays, [191][192][193][194][195][196][197][198][199][200][201][202][203] some based on electrochemical readout and antibody probes, [204] for the monitoring of cardiac biomarkers such as troponin, brain type natriuretic peptide (BNP), pro-hormone BNP (pro-BNP), and N-terminal prohormone BNP (NT pro-BNP). [204][205][206] To take advantage of the better storage stability and shelf life of nucleic acids compared to antibodies, a range of aptamers have been selected for targeting cardiac biomarkers, including troponin, [207][208][209][210][211] myoglobin, [212,213] creatine kinase, [214] heart-type fatty-acid-binding protein (hFABP), [215] B-type natriuretic peptide (BNP), [216][217][218] Interleukin-6 (IL-6), [219][220][221][222] and C-reactive protein (CRP).…”

Paper-Based All-in-One Origami Nanobiosensor for Point-of-Care Detection of Cardiac Protein Markers in Whole Blood

“…Rapid on-site diagnosis of infectious diseases has become increasingly important, which was recently highlighted by the COVID-19 pandemic . Significant efforts have been devoted to developing microfluidic platforms for point-of-care (POC) blood testing of cardiac biomarkers, − which are typically constructed from elastomer (e.g., polydimethylsiloxane, PDMS) and plastic materials and employ a variety of biosensing mechanisms such as electrochemistry ,− and chemiluminescence. − In addition, several microfluidic diagnostic devices are commercially available for Cardiac Troponin I (cTnI) and Cardiac Troponin T (cTnT) detection, such as the i-STAT System from Abbott and the Triage Meter Pro from Quidel…”

“…5 Significant efforts have been devoted to developing microfluidic platforms for point-of-care (POC) blood testing of cardiac biomarkers, 6−9 which are typically constructed from elastomer (e.g., polydimethylsiloxane, PDMS) and plastic materials and employ a variety of biosensing mechanisms such as electrochemistry 4,10−12 and chemiluminescence. 13 detection, 19 such as the i-STAT System from Abbott 20 and the Triage Meter Pro from Quidel. 21 Besides conventional PDMS and plastic-based microfluidic devices, microfluidic paper-based analytical devices (μPADs) represent another promising platform technology for CVD diagnostics.…”