Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter March 15, 2021

Additional approaches for identifying non-reproducible cardiac troponin results

Peter A. Kavsak

Corresponding author: Dr. Peter A. Kavsak,McMaster University, Hamilton, ON, Canada; and Juravinski Hospital and Cancer Centre, Hamilton Health Sciences, 711 Concession Street, Hamilton, ON, L8V 1C3, Canada, Phone: +1 905 521 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, Quidel, Randox Laboratories, Roche Diagnostics and Siemens Healthcare Diagnostics. McMaster University has filed patents with Dr. Kavsak listed as an inventor in the acute cardiovascular biomarker field.

References

1. Favresse, J, Cadrobbi, J, Eucher, C, Laffineur, K, Rosseels, C, Pieters, D, et al.. Non-reproducible cardiac troponin results occurring with a particular reagent lot. Clin Chem Lab Med 2021;59:e9–12. https://doi.org/10.1515/cclm-2020-0562.Search in Google Scholar

2. Favresse, J, Bayart, J-L, Gruson, D, Bernardini, S, Clerico, A, Perrone, M. The underestimated issue of non-reproducible cardiac troponin I and T results: case series and systematic review of the literature. Clin Chem Lab Med 2021;59:1201–11. https://doi.org/10.1515/cclm-2020-1564.Search in Google Scholar

3. Macrae, AR, Kavsak, PA, Lustig, V, Bhargava, R, Vandersluis, R, Palomaki, GE, et al.. Assessing the requirement for the 6-hour interval between specimens in the American Heart Association Classification of myocardial infarction in epidemiology and clinical research studies. Clin Chem 2006;52:812–8. https://doi.org/10.1373/clinchem.2005.059550.Search in Google Scholar

4. Thygesen, K, Alpert, JS, White, HD, Joint ESC/AACF/AHA/WHF Task Force for the redefinition of myocardial infarction. Universal definition of myocardial infarction. J Am Coll Cardiol 2007;50:2173–95. https://doi.org/10.1016/j.jacc.2007.09.011.Search in Google Scholar

5. Kavsak, PA, MacRae, AR, Yerna, MJ, Jaffe, AS. Analytic and clinical utility of a next-generation, highly sensitive cardiac troponin I assay for early detection of myocardial injury. Clin Chem 2009;55:573–7. https://doi.org/10.1373/clinchem.2008.116020.Search in Google Scholar

6. Kavsak, PA, Clark, L, Lancaster, S, Don-Wauchope, AC. Within-run precision and outlier detection for the Abbott ARCHITECT cardiac troponin I assay. Ann Clin Biochem 2014;51:512–4. https://doi.org/10.1177/0004563214534400.Search in Google Scholar

7. Kittanakom, S, Ly, V, Arnoldo, A, Beattie, A, Kavsak, PA. Pre-analytical variables affecting discordant results on repeat sample testing for cardiac troponin I. Clin Biochem 2019;63:158–60. https://doi.org/10.1016/j.clinbiochem.2018.10.014.Search in Google Scholar

8. Thygesen, K, Alpert, JS, Jaffe, AS, Chaitman, BR, Bax, JJ, Morrow, DA, et al.. Fourth Universal definition of myocardial infarction (2018). Circulation 2018;138:e618–51. https://doi.org/10.1161/cir.0000000000000617.Search in Google Scholar

9. Chapman, AR, Anand, A, Boeddinghaus, J, Ferry, AV, Sandeman, D, Adamson, PD, et al.. Comparison of the efficacy and Safety of early rule-out pathways for acute myocardial infarction. Circulation 2017;135:1586–96. https://doi.org/10.1161/circulationaha.116.025021.Search in Google Scholar

10. Neumann, JT, Twerenbold, R, Ojeda, F, Sörensen, NA, Chapman, AR, Shah, ASV, et al.. Application of high-sensitivity troponin in Suspected myocardial infarction. N Engl J Med 2019;380:2529–40. https://doi.org/10.1056/NEJMoa1803377.Search in Google Scholar

11. Collet, JP, Thiele, H, Barbato, E, Barthélémy, O, Bauersachs, J, Bhatt, DL, et al.. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2020 Aug 29. https://doi.org/10.1093/eurheartj/ehaa575 [Epub ahead of print].Search in Google Scholar

12. 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.Search in Google Scholar

13. 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. https://doi.org/10.1093/clinchem/hvaa160.Search in Google Scholar

14. Kavsak, PA, Ainsworth, C, Worster, A. An approach to investigate discordant high-sensitivity cardiac troponin I results. Can J Cardiol 2020. https://doi.org/10.1016/j.cjca.2020.11.005.Search in Google Scholar

15. Kavsak, PA, Malinowski, P, Roy, C, Clark, L, Lamers, S. Assessing matrix, interferences and comparability between the Abbott Diagnostics and the Beckman Coulter high-sensitivity cardiac troponin I assays. Clin Chem Lab Med 2018;56:1176–81. https://doi.org/10.1515/cclm-2017-1122.Search in Google Scholar

16. Kavsak, PA, Roy, C, Malinowski, P, Clark, L, Lamers, S, Bamford, K, et al.. Sample matrix and high-sensitivity cardiac troponin I assays. Clin Chem Lab Med 2019;57:745–51. https://doi.org/10.1515/cclm-2018-1100.Search in Google Scholar

17. Kavsak, PA, Kittanakom, S. Impact of Switching sample types for high-sensitivity cardiac troponin I assays in the 0/1 hour algorithms. Clin Chem 2021;67:319–21. https://doi.org/10.1093/clinchem/hvaa191.Search in Google Scholar

18. Kavsak, PA, Edge, T, Roy, C, Malinowski, P, Bamford, K, Clark, L, et al.. Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay. Clin Chem Lab Med 2021;59:749–55. https://doi.org/10.1515/cclm-2020-1115.Search in Google Scholar

19. Kavsak, PA, Cerasuolo, JO, Ko, DT, Ma, J, Sherbino, J, Mondoux, SE, et al.. Using the clinical chemistry score in the emergency department to detect adverse cardiac events: a diagnostic accuracy study. CMAJ Open 2020 ;8:E676–84. https://doi.org/10.9778/cmajo.20200047.Search in Google Scholar

20. 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 Jan 13. https://doi.org/10.1016/j.cjca.2021.01.004 [Epub ahead of print].Search in Google Scholar

21. Kavsak, PA, Mansour, M, Wang, L, Campeau, S, Clark, L, Brooks, D, et al.. Assessing pneumatic tube systems with patient-specific populations and laboratory-derived criteria. Clin Chem 2012;58:792–5. https://doi.org/10.1373/clinchem.2011.179044.Search in Google Scholar

22. 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.Search in Google Scholar

23. Kavsak, PA, Mondoux, SE, Sherbino, J, Ma, J, Clayton, N, Hill, SA, et al.. Clinical evaluation of Ortho Clinical Diagnostics high-sensitivity cardiac Troponin I assay in patients with symptoms suggestive of acute coronary syndrome. Clin Biochem 2020;80:48–51. https://doi.org/10.1016/j.clinbiochem.2020.04.003.Search in Google Scholar

Received: 2021-01-20
Accepted: 2021-03-03
Published Online: 2021-03-15
Published in Print: 2021-06-25

© 2021 Walter de Gruyter GmbH, Berlin/Boston

Scroll Up Arrow