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 | ||||||||||||||||||||||||
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| 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 |
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| Journal or Publication Title: | Clinical Chemistry and Laboratory Medicine (CCLM) | ||||||||||||||||||||||||
| ISSN: | 1434-6621 | ||||||||||||||||||||||||
| Language: | en | ||||||||||||||||||||||||
| Media of Output: | Print-Electronic | ||||||||||||||||||||||||
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| Publisher License: | Publisher's own licence | ||||||||||||||||||||||||
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| PubMed ID: | 40892069 | ||||||||||||||||||||||||
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| URI: | https://openaccess.sgul.ac.uk/id/eprint/117933 | ||||||||||||||||||||||||
| Publisher's version: | https://doi.org/10.1515/cclm-2025-0374 |
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