Real-world analytical and diagnostic evaluation of the Abbott i-STAT Alinity point-of-care high-sensitivity troponin I assay in a UK emergency department.

Authors

Angela Dawn Burns, Vaishnavi Muthukrishnan, Usmaan Razzaq, Louise Boughen, David Paisley, Andrew Saunders, Faheem Ahmad, Ian M Godber

Published in

Annals of clinical biochemistry. Pages 45632261499915. Oct 08, 2026. Epub Oct 08, 2026.

Abstract

High-sensitivity cardiac troponin (hs-cTn) testing is central to emergency department assessment of suspected acute coronary syndrome. Point-of-care hs-cTn testing may reduce turnaround time, but local analytical and clinical evaluation is required before implementation.
In a single-centre real-world evaluation, paired whole-blood and plasma samples from patients with suspected acute coronary syndrome were analysed using the Abbott i-STAT Alinity point-of-care hs-cTnI assay and the Alinity laboratory hs-cTnI assay. Imprecision, method comparison, threshold concordance, diagnostic discrimination for adjudicated Type 1 myocardial infarction (MI), and potential effects of haemolysis, icterus, lipaemia and haematocrit were assessed.
Low-level imprecision was below 10% CV. Concordance at the <5 ng/L rule-out threshold was high (84.1%); all discordant classifications reflected higher POCT values, with no false-negative rule-outs. Both assays showed similar discrimination for adjudicated Type 1 MI and 100% observed sensitivity and negative predictive value at the 5 ng/L threshold, although confidence intervals were wide. POCT specificity was lower than laboratory specificity. Method comparison showed a modest positive POCT bias, and regression analyses did not identify clinically meaningful effects of haemolysis, icterus, lipaemia or haematocrit.
The Abbott i-STAT Alinity POCT hs-cTnI assay demonstrated analytical performance and clinical concordance supportive of local implementation, with similar diagnostic discrimination to the Alinity laboratory hs-cTnI assay in a small cohort. Larger prospective studies are needed to confirm clinical safety and workflow impact.

PMID:
42850204
Bibliographic data and abstract were imported from PubMed on 09 Oct 2026.

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