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

  • James Hatherley , Sarah Davies , Suzannah Phillips , Ahmed Dakshi , Guy Miller , Lisa Bailey , Paul Collinson und Aleem Khand EMAIL logo
Veröffentlicht/Copyright: 3. September 2025
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 64 Heft 1

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.

Keywords: troponin; point-of-care; central laboratory; myocardial infarction
Corresponding author: Prof Aleem Khand, Liverpool University Hospital NHS Foundation Trust, Longmoor lane, L97AL, Liverpool, UK, E-mail:

Funding source: Abbott Diagnostics

Funding source: Quidelortho

Funding source: Liverpool University Hospitals NHS Foundation Trust

Funding source: Siemens Healthineers

Funding source: northwest coast academic science network

Acknowledgments

The staff of the Emergency Departments within Liverpool University Hospitals NHS Foundation Trust. The staff within Liverpool Clinical Laboratories.

  1. Research ethics: MACROS-2 received approval from the Health Research Authority and local Research Ethics Committee (REC reference 21/EM/0202). The study is consistent with the declaration of Helsinki. All patients were consented with specific use of additional venous whole blood for the investigational VTLi POC assay and storage for subsequent analysis of CL hs-cTnI assays.

  2. Informed consent: All patients gave informed written consent after receiving a patient information leaflet regarding the study.

  3. Author contributions: AK is the senior author and was involved in conceptualization, manuscript editing and is chief investigator of MACROS-2. POC was involved in conceptualization, manuscript editing and statistical analysis for imprecision data. GM was involved in manuscript editing and data collection. SD contributed to manuscript writing/editing and statistical analysis. JH contributed to conceptualization, was the lead for manuscript writing and editing and also undertook the majority of the statistical analysis. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: 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, Abbott Diagnostics. 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). Please note Siemens Healthineers previewed the manuscript but all decision making and intellectual property resides with the authors.

  6. Research funding: Funding for the Mersey Acute Coronary syndrome Rule Out Study-2, which this manuscript is a sub-study of: Siemens Healthcare Diagnostics Limited, Faraday House, Sir Williams Square, Frimley, Camberley, Surrey GU16 8QD. Amount: £40000. Quidel Cardiovascular Inc., San Diego, CA 91121, USA. Amount: £205000. Charitable funds of St. Georges Hospital Biochemistry Department, London, UK. Amount: £10000. Abbott Diagnostics, Lake Forest, USA. Amount £50000 (Financial assistance) and £60000 (Sample analysis). Menarini UK, Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH. Amount: £15000. Liverpool University Hospital NHS Foundation Trust, Longmoor Lane, Liverpool, L9 7AL. Amount: £60000. Innovation agency, North-West Coast, NHS England, Vanguard House, Keckwith Lane, WA4 4AB. Amount: £47962. Liverpool University Hospital Charitable funding: £30000. Cartridges and devices provided FOC by Siemens.

  7. Data availability: The data that support the findings of this study are available on request from the corresponding author, AK. The data are not publicly available due to privacy/ethical/legal/commercial restrictions.

References

1. Thygesen, K, Alpert, JS, Jaffe, AS, Chaitman, BR, Bax, JJ, Morrow, DA, et al.. Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol 2018;72:2231–64. https://doi.org/10.1016/j.jacc.2018.08.1038.Suche in Google Scholar PubMed

2. Apple, FS, Jaffe, AS, Collinson, P, Mockel, M, Ordonez-Llanos, J, Lindahl, B, et al.. IFCC educational materials on selected analytical and clinical applications of high sensitivity cardiac troponin assays. Clin Biochem 2015;48:201–3. https://doi.org/10.1016/j.clinbiochem.2014.08.021.Suche in Google Scholar PubMed

3. Xiong-Hang, K, Schulz, K, Sandoval, Y, Smith, SW, Saenger, AK, Apple, FS. Analytical performance comparing siemens whole blood point of care Atellica VTLi to the central laboratory plasma Atellica IM high-sensitivity cardiac troponin I assays. Clin Biochem 2023;114:79–85. https://doi.org/10.1016/j.clinbiochem.2023.02.004.Suche in Google Scholar PubMed

4. Apple, FS, Schulz, K, Schmidt, CW, van Domburg, TSY, Fonville, JM, de Theije, FK. Determination of sex-specific 99th percentile upper reference limits for a point of care high sensitivity cardiac troponin I assay. Clin Chem Lab Med 2021;59:1574–8. https://doi.org/10.1515/cclm-2021-0262.Suche in Google Scholar PubMed

5. Christenson, RH, Frenk, LDS, de Graaf, HJ, van Domburg, TSY, Wijnands, FPG, Foolen, HWJ, et al.. Point-of-care: roadmap for analytical characterization and validation of a high-sensitivity cardiac troponin I assay in plasma and whole blood matrices. J Appl Lab Med 2022;7:971–88. https://doi.org/10.1093/jalm/jfac028.Suche in Google Scholar PubMed

6. International Federation of Clinical Chemistry and Laboratory Medicine. High-sensitivity cardiac troponin I and T assay analytical characteristics designated by manufacturer IFCC committee on clinical applications of cardiac bio-markers (C-CB); 2024. www.ifcc.org.Suche in Google Scholar

7. Carey, RN, Durham, AP, Hauck, WW, Kallner, A, Kondratovich, MV, Middle, JG, et al.. User verification of precision and estimation of bias; approved guideline - Third edition. EP15-A3, 12th ed.; 2014, vol 34.Suche in Google Scholar

8. Sandberg, S, Coskun, A, Carobene, A, Fernandez-Calle, P, Diaz-Garzon, J, Bartlett, WA, et al.. Analytical performance specifications based on biological variation data – considerations, strengths and limitations. Clin Chem Lab Med 2024;62:1483–9. https://doi.org/10.1515/cclm-2024-0108.Suche in Google Scholar PubMed

9. Li, Z, Tew, YY, Kavsak, PA, Aakre, KM, Jaffe, AS, Apple, FS, et al.. Impact of high-sensitivity cardiac troponin I assay imprecision on the safety of a single-sample rule-out approach for myocardial infarction. Clin Chem Lab Med 2024;63:e59. https://doi.org/10.1515/cclm-2024-1011.Suche in Google Scholar PubMed PubMed Central

10. Aakre, KM, Apple, FS, Mills, NL, Meex, SJR, Collinson, PO. Lower limits for reporting high-sensitivity cardiac troponin assays and impact of analytical performance on patient misclassification. Clin Chem. 2023;70:497. https://doi.org/10.1093/clinchem/hvad185.Suche in Google Scholar PubMed

11. European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). EFLM biological variation database; 2025. https://biologicalvariation.eu.Suche in Google Scholar

12. Kavsak, PA, Clark, L, Arnoldo, S, Lou, A, Shea, JL, Eintracht, S, et al.. Analytic result variation for high-sensitivity cardiac troponin: interpretation and consequences. Can J Cardiol 2023;39:947–51. https://doi.org/10.1016/j.cjca.2023.04.013.Suche in Google Scholar PubMed

13. Pickering, JW, Kavsak, P, Christenson, RH, Troughton, RW, Pemberton, CJ, Richards, AM, et al.. Determination of clinically acceptable analytical variation of cardiac troponin at decision thresholds. Clin Chem 2024;70:967–77. https://doi.org/10.1093/clinchem/hvae059.Suche in Google Scholar PubMed

14. Kavsak, PA, Jaffe, AS, Greene, DN, Christenson, RH, Apple, FS, Wu, AHB. Total analytic error for low cardiac troponin concentrations (≤10 ng/L) by use of a high-sensitivity cardiac troponin assay. Clin Chem 2017;63:1043–5. https://doi.org/10.1373/clinchem.2017.271361.Suche in Google Scholar PubMed

15. Kavsak, PA, Don-Wauchope, AC, Hill, SA, Worster, A. Acceptable analytical variation may exceed high-sensitivity cardiac troponin I cutoffs in early rule-out and rule-in acute myocardial infarction algorithms. Clin Chem 2016;62:887–9. https://doi.org/10.1373/clinchem.2016.255448.Suche in Google Scholar PubMed

16. Lyon, AW, Kavsak, PA, Lyon, OAS, Worster, A, Lyon, ME. Simulation models of misclassification error for single thresholds of high-sensitivity cardiac troponin I due to assay bias and imprecision. Clin Chem 2017;63:585–92. https://doi.org/10.1373/clinchem.2016.265058.Suche in Google Scholar PubMed

17. Cullen, L, Greenslade, J, Parsonage, W, Stephensen, L, Smith, SW, Sandoval, Y, et al.. Point-of-care high-sensitivity cardiac troponin in suspected acute myocardial infarction assessed at baseline and 2 h. Eur Heart J 2024;45:2508–15. https://doi.org/10.1093/eurheartj/ehae343.Suche in Google Scholar PubMed

18. Haagensen, K, Collinson, P, Åsberg, A, Aakre, KM. How does the analytical quality of the high-sensitivity cardiac troponin T assay affect the ESC rule out algorithm for NSTEMI? Clin Chem 2019;65:494–6. https://doi.org/10.1373/clinchem.2018.298703.Suche in Google Scholar PubMed

19. Wu, AHB, Christenson, RH, Greene, DN, Jaffe, AS, Kavsak, PA, Ordonez-Llanos, J, et al.. Clinical laboratory practice recommendations for the use of cardiac troponin in acute coronary syndrome: expert opinion from the academy of the American association for clinical chemistry and the task force on clinical applications of cardiac bio-markers of the international federation of clinical chemistry and laboratory medicine. Clin Chem 2018;64:645–55. https://doi.org/10.1373/clinchem.2017.277186.Suche in Google Scholar PubMed

20. Florkowski, CM, Buchan, V, Li, BV, Taylor, F, Phan, M, Than, M, et al.. Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay. Clin Chem Lab Med 2024;63:433–9. https://doi.org/10.1515/cclm-2024-0312.Suche in Google Scholar PubMed

21. Curran, JM, Mergo, A, White, S, Croal, BL, Cooper, JG. High-sensitivity troponin testing at the point of care for the diagnosis of myocardial infarction: a prospective emergency department clinical evaluation. Emerg Med J 2024;41:321–3. https://doi.org/10.1136/emermed-2023-213633.Suche in Google Scholar PubMed

22. Sammartano, A, Buonocore, R, Fiorini, R, Dieci, E, Di Franco, A, Di, SB, et al.. A comparison study: possible bias in troponin I measurement obtained with a point of care testing and a central laboratory analyzers employing different biological matrices and anticoagulants. Diagnostics 2024;14:1482. https://doi.org/10.3390/diagnostics14141482.Suche in Google Scholar PubMed PubMed Central

23. de Bakker, M, Anand, A, Shipley, M, Fujisawa, T, Shah, ASV, Kardys, I, et al.. Sex differences in cardiac troponin trajectories over the life course. Circulation 2023;147:1798–808. https://doi.org/10.1161/circulationaha.123.064386.Suche in Google Scholar

24. Kimenai, DM, Shah, ASV, McAllister, DA, Lee, KK, Tsanas, A, Meex, SJR, et al.. Sex differences in cardiac troponin I and T and the prediction of cardiovascular events in the general population. Clin Chem 2021;67:1351–60. https://doi.org/10.1093/clinchem/hvab109.Suche in Google Scholar PubMed PubMed Central

25. Mair, J, Lindahl, B, Müller, C, Giannitsis, E, Huber, K, Möckel, M, et al.. What to do when you question cardiac troponin values. Eur Heart J Acute Cardiovasc Care 2018;7:577–86. https://doi.org/10.1177/2048872617708973.Suche in Google Scholar PubMed

Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0374).

Received: 2025-03-26
Accepted: 2025-08-22
Published Online: 2025-09-03
Published in Print: 2026-01-27

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0374
Schlagwörter für diesen Artikel
troponin; point-of-care; central laboratory; myocardial infarction

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Keeping pace with patient safety by developing and qualifying higher-order reference measurement procedures for laboratory measurement standardization
  4. Review
  5. The role of AI in pre-analytical phase – use cases
  6. Opinion Paper
  7. Total laboratory automation: fit for its intended purposes?
  8. Guidelines and Recommendations
  9. EFLM checklist for the assessment of AI/ML studies in laboratory medicine: enhancing general medical AI frameworks for laboratory-specific applications
  10. Candidate Reference Measurement Procedures and Materials
  11. An isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedure for the quantification of cortisol in human serum and plasma
  12. Isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedures for the quantification of 24(R),25-dihydroxyvitamin D2 and 24(R),25-dihydroxyvitamin D3 in human serum and plasma
  13. An isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedure for the quantification of cortisone in human serum and plasma
  14. Candidate reference measurement procedure based on isotope dilution-two dimensional-liquid chromatography-tandem mass spectrometry for the quantification of androstenedione in human serum and plasma
  15. An isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedure for the quantification of 17β-estradiol in human serum and plasma
  16. Isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedures for the quantification of total and free phenytoin in human serum and plasma
  17. An isotope dilution-liquid chromatography-tandem mass spectrometry based candidate reference measurement procedure for the simultaneous quantification of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in human serum and plasma
  18. General Clinical Chemistry and Laboratory Medicine
  19. Quality assurance using patient split samples: recommendations for primary healthcare laboratories
  20. Age distorts the interpretation of FIB-4
  21. Not all anti-parietal cell antibody tests are equal for diagnosing pernicious anemia
  22. Impact of renal and hepatic function on dihydropyrimidine dehydrogenase phenotype assessed by enzyme activity in peripheral blood mononuclear cells and uracilemia
  23. Fecal leukocyte esterase levels predict endoscopic severity as an alternative biomarker in inflammatory bowel disease
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  25. CA-125 glycovariant assays enhance diagnostic sensitivity in the detection of epithelial ovarian cancer
  26. Cardiovascular Diseases
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  28. An automatic chemiluminescence immunoassay for a novel biomarker NT-IGFBP-4: analytical performance and clinical relevance in heart failure
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  32. Infectious Diseases
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  34. Proadrenomedullin for prediction of early and mid-term mortality in patients hospitalized for community-acquired pneumonia
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  36. Reviewer Acknowledgment
  37. Letters to the Editor
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  39. Are vitamins A and E results truly traceable and clinically useful? A practical and critical inquiry
  40. Tafasitamab interference in immunofixation electrophoresis
  41. Improvement in the turnaround time of PTH(1–84) as part of the intraoperative PTH monitoring for parathyroidectomy
  42. Rethinking the use of “one-way ANOVA” in CLSI EP15-A3 – a call for terminological precision and methodological clarity
  43. Toxic beauty: acute kidney injury triggered by hair-straightening treatment
  44. Congress Abstracts
  45. 57th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
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