Lot-to-lot variation: no longer a neglected issue
Author:
Affiliation:
1. Clinical Biochemistry and Clinical Molecular Biology , University of Padova , Padua , Italy
2. QI.LAB.MED, Spin-off of the University of Padova , Padua , Italy
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
Link
https://www.degruyter.com/document/doi/10.1515/cclm-2022-0128/pdf
Reference10 articles.
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2. McCormack, JP, Holmes, DT. Your results may vary: the imprecision of medical measurements. BMJ 2020;368:m149. https://doi.org/10.1136/bmj.m149.
3. Panteghini, M, Ceriotti, F, Jones, G, Oosterhuis, W, Plebani, M, Sandberg, S, et al. Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference. Clin Chem Lab Med 2017;55:1849–56. https://doi.org/10.1515/cclm-2017-0772.
4. van Rossum, HH, Bietenbeck, A, Cervinski, MA, Katayev, A, Loh, TP, Badrick, TC. Benefits, limitations, and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice. Clin Chem Lab Med 2021;59:1213–20. https://doi.org/10.1515/cclm-2021-0072.
5. Loh, TP, Sandberg, S, Horvath, AR. Lot-to-lot reagent verification: challenges and possible solutions. Clin Chem Lab Med 2022;60:675–80. https://doi.org/10.1515/cclm-2022-0092.
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2. Issues in assessing analytical performance specifications in healthcare systems assembling multiple laboratories and measuring systems;Clinical Chemistry and Laboratory Medicine (CCLM);2024-02-09
3. When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias;Clinical Chemistry and Laboratory Medicine (CCLM);2024-02-08
4. 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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