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Evaluation of the analytical and clinical performance of a high-sensitivity troponin I point-of-care assay in the Mersey Acute Coronary Syndrome Rule Out Study (MACROS-2)

  • Ahmed Dakshi , James Hatherley , Paul Collinson , Suzannah Phillips , Lisa Bailey , Guy Miller , Matthew Shaw and Aleem Khand EMAIL logo
Published/Copyright: September 2, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 2

Abstract

Objectives

The objective of this study is to evaluate the analytical and diagnostic performance of a high-sensitivity point-of-care (POC) cardiac troponin I assay, the Quidel TriageTrue™ (QuidelOrtho Inc, San Diego, USA), compared to central laboratory testing (CLT) in accelerated diagnostic protocols (ADP) in real time in a clinical environment.

Methods

In a nested sub-study of a pragmatic randomised control trial, consecutive patients with suspected acute coronary syndrome (ACS) and chest pain <12 h duration were randomised to the ESC 0/1 and 0/3-h ADP. Subjects underwent sampling for Quidel TriageTrue POC hs-TnI whole blood and plasma, CLT hs-TnT Roche Elecsys and a validated, NICE approved CLT High sensitivity cardiac troponin I (hs-TnI) (Siemens Attellica) at each time point. Assay imprecision was assessed by repeat analysis of whole blood samples at three levels (low, near 10 % CV 5–10 ng/L, medium, approximating 99th percentile 15–25 ng/L and high, 3–5 times the 99th percentile, 60–100 ng/L). Final diagnosis was adjudicated at 6 weeks by Roche hs-TnT using the 4th universal definition of myocardial infarction (MI).

Results

A total of 1,157 patients consented and had both investigational POC whole blood and plasma and central lab hs-cTn available. The median age was 59, 47.2 % were female and 15 % had suffered a previous MI. Assay imprecision of whole blood POC TriageTrue revealed 10 % CV at 8.6 ng/L (>50 % lower than 99th percentile [20.5 ng/L]) and a 20 % CV at 1.2 ng/L. Receiver operator characteristics (ROC) curves were computed for each assay against adjudicated index type 1 MI to study clinical performance. At all-time points there were excellent performance for whole blood POC TriageTrue: area under the curve (AUC) 0.97 [95 % CI 0.94–098], 0.98 [95 % CI 0.97–1.00] and 0.95 [95 % CI 0.92–0.98] at time 0, 1 and 3 h respectively. There was statistical equivalence for performance of whole blood and plasma POC TriageTrue hs-TnI and laboratory Siemens Atellica hs-TnI.

Conclusions

The whole blood POC TriageTrue hs-TnI assay demonstrates imprecision levels consistent with high sensitivity characteristics and has a clinical performance equivalent to an established, validated and NICE approved laboratory Siemens Atellica hs-TnI.

Keywords: high sensitivity troponin; point of care testing; acute coronary syndrome
Corresponding author: Prof. Aleem Khand, Department of Cardiology, Liverpool University Hospital NHS Foundation Trust, Longmoor Lane, Liverpool L97AL, UK; Institute of Ageing and Chronic Diseases, University of Liverpool, Liverpool, UK; and Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, UK, E-mail:

Funding source: quidel corporation

Funding source: Abbott Diagnostics

Funding source: north west coast academic science network

Funding source: liverpool university hospital nhs foundation trust

Acknowledgments

The authors would like to thank Dr Michael Campbell for his help in editing and critique of the manuscript.

  1. Research ethics: The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).

  2. Informed consent: Informed consent was obtained from all individuals included in this study.

  3. Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: Dr A Khand has been a Speaker or expert member and has received fees from the following companies: Bayer, Daiichi Sankyo, Astra Zeneca, Menarini, St Jude, Abbot Vascular. Dr A Khand has received research funds from the following companies: Bayer medical, Menarini, Dragons Den awards (Liverpool University hospitals). Dr A Khand holds research contracts with Abbott Diagnostics. Dr A Khand is the director for Northwest Educational Cardiac Group (nwecg), a not for profit medical educational group and has received sponsorship for educational courses from Bayer, Astra Zeneca, Genzyme (Sanofi), Daiichi Sankyo, Circle Cardiovascular, Menarini, Circle. Dr A Khand works with the Northwest coast Innovation agency in England, is a clinical Champion for high sensitive troponins with funds awarded (both personal payment for work and transformation funding) for dissemination of accelerated diagnostic pathways. P.O. Collinson, Associate Editor of The Journal of Applied Laboratory Medicine, ADLM; received honoraria for lectures from Siemens Healthineers; on the advisory board of Psyros Diagnostics and Radiometer and has previously advised Siemens Healthineers and LumiraDx; consultant to IFCC Committee on Clinical Applications of Cardiac Bio-Markers (C-CB) (unpaid). All other authors state no conflict of interest.

  5. Research funding: Innovation agency, North–West Coast, NHS England, Liverpool University Hospital NHS Foundation Trust, Menarini UK, Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, Abbott Diagnostics, Lake Forest, USA (Charitable funds of St. Georges University Hospital Biochemistry department), Quidel Cardiovascular Inc. Siemens Healthcare Diagnostics Limited, National Institute of Health Research.

  6. Data availability: The raw data can be obtained on request from the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0138).

Received: 2024-01-28
Accepted: 2024-08-13
Published Online: 2024-09-02
Published in Print: 2025-01-29

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0138
Keywords for this article
high sensitivity troponin; point of care testing; acute coronary syndrome

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
  7. Opinion Papers
  8. Advancing value-based laboratory medicine
  9. Clostebol and sport: about controversies involving contamination vs. doping offence
  10. Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement
  11. Perspectives
  12. An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results
  13. Genetics and Molecular Diagnostics
  14. Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia
  15. General Clinical Chemistry and Laboratory Medicine
  16. IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool
  17. Analytical performance specifications for trace elements in biological fluids derived from six countries federated external quality assessment schemes over 10 years
  18. The effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses
  19. Accurate non-ceruloplasmin bound copper: a new biomarker for the assessment and monitoring of Wilson disease patients using HPLC coupled to ICP-MS/MS
  20. Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, “PLT clumps?” flag, and “PLT abnormal histogram” flag on the Mindray BC-6800plus hematology analyzer in clinical practice
  21. Evaluation of serum NFL, T-tau, p-tau181, p-tau217, Aβ40 and Aβ42 for the diagnosis of neurodegenerative diseases
  22. An immuno-DOT diagnostic assay for autoimmune nodopathy
  23. Evaluation of biochemical algorithms to screen dysbetalipoproteinemia in ε2ε2 and rare APOE variants carriers
  24. Reference Values and Biological Variations
  25. Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data
  26. Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease
  27. Agreement of lymphocyte subsets detection permits reference intervals transference between flow cytometry systems: direct validation using established reference intervals
  28. Cancer Diagnostics
  29. Atypical cells in urine sediment: a novel biomarker for early detection of bladder cancer
  30. External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA
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