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. 2024 Sep 20;63(3):e59-e62.
doi: 10.1515/cclm-2024-1011. Print 2025 Feb 25.

Impact of high-sensitivity cardiac troponin I assay imprecision on the safety of a single-sample rule-out approach for myocardial infarction

Ziwen Li  1 , Yong Yong Tew  1 , Peter A Kavsak  2 , Kristin M Aakre  3   4 , Allan S Jaffe  5 , Fred S Apple  6   7   8 , Paul O Collinson  9 , Nicholas L Mills  1   10 ; High-STEACS Trial Investigators
Affiliations

Impact of high-sensitivity cardiac troponin I assay imprecision on the safety of a single-sample rule-out approach for myocardial infarction

Ziwen Li et al. Clin Chem Lab Med. .
No abstract available

Keywords: high-sensitivity cardiac troponin; imprecision; myocardial infarction; single-sample rule-out.

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Conflict of interest statement

Competing interests: Dr Kavsak has received grants/reagents/consultant/advisor/ honoraria from Abbott Laboratories, Beckman Coulter, Ortho Clinical Diagnostics, Quidel, Randox Laboratories, Roche Diagnostics, Siemens Healthcare Diagnostics, and Thermo Fisher Scientific. McMaster University has the following patent with Dr Kavsak being a listed inventor “Method of Determining Risk of an Adverse Cardiac Event.” McMaster University has also filed the following patent: “Quality Control Materials For Cardiac Troponin Testing” with Dr Kavsak being a listed inventor. Dr Aakre has served on advisory boards for Roche Diagnostics, Siemens Healthineers and SpinChip, received consultant honoraria form CardiNor, lecturing honorarium from Siemens Healthineers, Mindray and Snibe Diagnostics, and research grants from Siemens Healthineers and Roche Diagnostics; she is Associate Editor of Clinical Biochemistry and Chair of the IFCC Committee of Clinical Application of Cardiac Bio-markers. Dr. Apple consults for Mindray, serves on advisory boards for Werfen and Abbott Vascular, is an Associate Editor at Clinical Chemistry, and has received research funding to Hennepin Healthcare Research Institute (non-salaried) from Abbott Diagnostics, Abbott POC, Beckman Dickenson, Beckman Coulter, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthcare, Sysmex, and Quidel/Ortho. Dr Jaffe reports consulting for most of the major diagnostic companies. He also has an equity interest in RCE Technologies. Dr Collinson has consulted for Psyros, LumiraDx, Radiometer, Siemens Healthineers and QuidelOrtho and is Consultant to the IFCC Committee of Clinical Application of Cardiac Bio-markers. Dr Mills is supported by a Research Excellence Award (RE/24/130012) and a Chair Award (CH/F/21/90010) from the British Heart Foundation and reports honoraria or speaker fees from Abbott Diagnostics, Siemens Healthineers, Roche Diagnostics, LumiraDx, and Psyros Diagnostics over the last 3 years. The remaining authors have no conflicts of interest to disclose.

Figures

Figure 1:
Figure 1:
Estimated proportion of patients with suspected acute coronary syndrome reclassified due to hs-cTnI assay imprecision at the rule-out threshold of <5 ng/L and likelihood of MI or myocardial injury in those misclassified as a proportion of the total number of patients at each measured cardiac troponin concentration. (A) Proportion reclassified as higher risk by assay imprecision (%). (B) Proportion reclassified as lower risk by assay imprecision (%). (C) Overall proportion reclassified by imprecision (%). (D) Likelihood of MI in those incorrectly classified as lower risk by imprecision (%). (E) Likelihood of myocardial injury in those incorrectly classified as lower risk by imprecision (%). Patients with STEMI (n=925) were excluded from the modelling.
See this image and copyright information in PMC

References

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