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Licensed Unlicensed Requires Authentication Published by De Gruyter January 17, 2023

Lot-to-lot bias for high-sensitivity cardiac troponin I concentrations ≥1000 ng/L

  • Peter A. Kavsak EMAIL logo

Corresponding author: Dr. Pete A. Kavsak, Juravinski Hospital and Cancer Centre, 711 Concession Street, Hamilton, ON L8V 1C3, Canada; McMaster University, Hamilton, ON, Canada; and Hamilton Health Sciences, Hamilton, ON, Canada, Phone: 905-521-2100, E-mail:

  1. Research funding: None declared.

  2. Author contributions: The author has accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Dr. Kavsak has received grants/reagents/consultant/advisor/honoraria from Abbott Laboratories, Abbott Point of Care, Beckman Coulter, Ortho Clinical Diagnostics, Randox Laboratories, Roche Diagnostics, Quidel, Siemens Healthcare Diagnostics and Thermo Fisher Scientific. McMaster University has filed patents with Dr. Kavsak listed as an inventor in the acute cardiovascular biomarker field.

  4. Informed consent: Not applicable.

  5. Ethical approval: This study is a quality assurance laboratory study with no patient identifiable information. Ethics approval not required by the Research Ethics Board.


1. Badrick, T, Ward, G, Hickman, P. The effect of the immunoassay curve fitting routine on bias in troponin. Clin Chem Lab Med 2022;61:188–95. in Google Scholar PubMed

2. Lyon, AW, Kavsak, PA, Lyon, OA, 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. in Google Scholar PubMed

3. Body, R, Burrows, G, Carley, S, Cullen, L, Than, M, Jaffe, AS, et al.. High-sensitivity cardiac troponin t concentrations below the limit of detection to exclude acute myocardial infarction: a prospective evaluation. Clin Chem 2015;61:983–9. in Google Scholar PubMed

4. Wu, AHB, Kavsak, PA, Aakre, KM, Christenson, RH, Greene, DN, Apple, FS, et al.. Lot-to-lot variation for commercial high-sensitivity cardiac troponin: can we realistically report down to the assay’s limit of detection? Clin Chem 2020;66:1146–9. in Google Scholar PubMed

5. Kavsak, PA, Cerasuolo, JO, Hewitt, MK, Mondoux, SE, Perez, R, Seow, H, et al.. Identifying very-low-risk patients for future myocardial infarction or death. Can J Cardiol 2022 Oct 17:S0828-282X(22)00970-9. [Epub ahead of print].Search in Google Scholar PubMed

6. Writing Committee for the VISION Study Investigators, Devereaux, PJ, Biccard, BM, Sigamani, A, Xavier, D, Chan, MTV, Srinathan, SK, et al.. Association of postoperative high-sensitivity troponin levels with myocardial injury and 30-day mortality among patients undergoing noncardiac surgery. JAMA 2017;317:1642–51. in Google Scholar PubMed

7. Thygesen, K, Alpert, JS, Jaffe, AS, Chaitman, BR, Bax, JJ, Morrow, DA, et al.. Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) task force for the universal definition of myocardial infarction. Fourth universal definition of myocardial infarction (2018). Circulation 2018;138:e618–51.10.1161/CIR.0000000000000617Search in Google Scholar PubMed

8. Devereaux, PJ, Lamy, A, Chan, MTV, Allard, RV, Lomivorotov, VV, Landoni, G, et al.. VISION cardiac surgery investigators. high-sensitivity troponin I after cardiac surgery and 30-day mortality. N Engl J Med 2022;386:827–36. in Google Scholar PubMed

9. Halvorsen, S, Mehilli, J, Cassese, S, Hall, TS, Abdelhamid, M, Barbato, E, et al.. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J 2022;43:3826–924. in Google Scholar PubMed

10. 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. in Google Scholar PubMed

11. Kavsak, PA, Worster, A, Oliver, R, Clark, L, Parry, D, Randell, E, et al.. Variability between reagent lots for high-sensitivity cardiac troponin I may affect performance of early rule out strategies. Can J Cardiol 2018;34:209.e5–e6. in Google Scholar PubMed

12. Kavsak, PA, Millar, E, McLay, G, Clark, L, Jaffe, AS. Between-day versus within-day imprecision using the Abbott high-sensitivity cardiac troponin I assay at concentrations around 5 ng/l. Clin Chim Acta 2019;489:58–60. in Google Scholar PubMed

13. 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. in Google Scholar PubMed

14. Aloisio, E, Pasqualetti, S, Dolc, A, Panteghini, M. Daily monitoring of a control material with a concentration near the limit of detection improves the measurement accuracy of highly sensitive troponin assays. Clin Chem Lab Med 2020;58:e29–31. in Google Scholar PubMed

15. Diaz-Garzon, J, Fernandez-Calle, P, Sandberg, S, Özcürümez, M, Bartlett, WA, Coskun, A, et al.. European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group on biological variation and task group for the biological variation database. Biological variation of cardiac troponins in health and disease: a systematic review and meta-analysis. Clin Chem 2021;67:256–64. in Google Scholar PubMed

16. Kavsak, PA, Mondoux, S, Worster, A, Martin, J, Tandon, V, Ainsworth, C, et al.. Misclassification of myocardial injury by a high-sensitivity cardiac troponin I assay. Can J Cardiol 2021;37:523.e7–e8. in Google Scholar PubMed

17. Kavsak, PA, Clark, L, Martin, J, Mark, CT, Paré, G, Mondoux, S, et al.. Acute phase response and non-reproducible elevated concentrations with a high-sensitivity cardiac troponin I assay. J Clin Med 2021;10:1014. in Google Scholar PubMed PubMed Central

18. Kavsak, PA, Ahmed, B, Hulett, M, Worster, A. Incidence and etiology of poor duplicate ortho high-sensitivity cardiac troponin I results in a community hospital emergency department. CJC Open 2022;4:1100–1. in Google Scholar PubMed PubMed Central

Received: 2023-01-06
Accepted: 2023-01-10
Published Online: 2023-01-17
Published in Print: 2023-06-27

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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