Lot-to-lot bias for high-sensitivity cardiac troponin I concentrations ≥1000 ng/L
Author:
Affiliation:
1. McMaster University , Hamilton , ON , Canada
2. Hamilton Health Sciences , Hamilton , ON , Canada
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
Link
https://www.degruyter.com/document/doi/10.1515/cclm-2023-0017/pdf
Reference18 articles.
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. https://doi.org/10.1515/cclm-2022-0657.
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. https://doi.org/10.1373/clinchem.2016.265058.
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. https://doi.org/10.1373/clinchem.2014.231530.
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. https://doi.org/10.1093/clinchem/hvaa160.
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. https://doi.org/10.1016/j.cjca.2022.10.014 [Epub ahead of print].
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2. The Clinical Validation of a Common Analytical Change Criteria for Cardiac Troponin for Ruling in an Acute Cardiovascular Outcome in Patients Presenting with Ischemic Chest Pain Symptoms;Journal of Cardiovascular Development and Disease;2023-08-04
3. In reply to: Limitations in using the EFLM WG-A/ISO approach for assessment of reagent lot variability;Clinical Chemistry and Laboratory Medicine (CCLM);2023-06-01
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