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Defining the analytical characteristics of a novel high-sensitivity point-of-care troponin I assay in its intended clinical environment

Hatherley, J; Davies, S; Phillips, S; Dakshi, A; Miller, G; Bailey, L; Collinson, P; Khand, A (2025) Defining the analytical characteristics of a novel high-sensitivity point-of-care troponin I assay in its intended clinical environment. Clinical Chemistry and Laboratory Medicine (CCLM). ISSN 1434-6621 https://doi.org/10.1515/cclm-2025-0374
SGUL Authors: Collinson, Paul

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Abstract

Objectives To assess the imprecision and stability of the point-of-care troponin I assay in the Emergency Department and its correlation and bias to two central laboratory troponin I assays (Siemens Atellica and Abbott Alinity). Methods Imprecision and stability testing was performed on opportunistically selected samples using whole blood in the emergency department by non-laboratory trained personnel. Assay comparisons were undertaken on samples taken from participants of the Mersey Acute Coronary syndrome Rule Out Study. Results The coefficient of variation (95 % confidence interval), at the 99th percentile for the point-of-care assay, was 8.1 % (6.1–12.1 %) but with a wide confidence interval reflective of considerable scatter at values just below the 99th percentile. The 10 % limit of quantification was 7.5 ng/L (1.7–61.8 ng/L). All samples met the ≤2 ng/L stability criteria for a duration of 4 h and under. The point-of-care assay very strongly correlated and had a negative bias with the Siemens Atellica and Abbott Alinity assays, Pearson’s R=0.99 and 0.95, mean difference −29.7 ng/L and −13.3 ng/L respectively. Conclusions The Siemens VTLi point-of-care assay fulfils high-sensitivity criteria when operated by non-laboratory trained staff using whole blood in its intended environment. Lithium heparin samples are likely stable up to 4 h. Significant bias between the point-of-care and two central laboratory assays negates the use of these assays interchangeably.

Item Type: Article
Additional Information: This is an Accepted​ Manuscript of an article published by De Gruyter​ in Clinical Chemistry and Laboratory Medicine on 03/09/2025, available at http://wwww.degruyter.com/10.1515/cclm-2025-0374.
Keywords: central laboratory, myocardial infarction, point-of-care, troponin
SGUL Research Institute / Research Centre: Academic Structure > Cardiovascular & Genomics Research Institute
Academic Structure > Cardiovascular & Genomics Research Institute > Clinical Cardiology
Journal or Publication Title: Clinical Chemistry and Laboratory Medicine (CCLM)
ISSN: 1434-6621
Language: en
Media of Output: Print-Electronic
Related URLs:
Publisher License: Publisher's own licence
Projects:
Project IDFunderFunder ID
UNSPECIFIEDAbbott Diagnosticshttps://doi.org/10.13039/100014386
UNSPECIFIEDLiverpool University Hospitals NHS Foundation Trusthttps://doi.org/10.13039/501100021117
UNSPECIFIEDNorthwest Coast Academic Science NetworkUNSPECIFIED
UNSPECIFIEDQuidel Cardiovascular IncUNSPECIFIED
UNSPECIFIEDSiemens Healthcare Diagnostics LimitedUNSPECIFIED
UNSPECIFIEDSt. Georges Hospital Biochemistry DepartmentUNSPECIFIED
UNSPECIFIEDMenarini UKUNSPECIFIED
PubMed ID: 40892069
Dates:
Date Event
2025-09-03 Published Online
2025-08-22 Accepted
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/117933
Publisher's version: https://doi.org/10.1515/cclm-2025-0374

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