Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter March 10, 2022

Biological variation and reference change value as decision criteria in clinical use of tumor biomarkers. Are they really useful?

  • Ruggero Dittadi ORCID logo EMAIL logo , Aline S.C. Fabricio ORCID logo and Massimo Gion ORCID logo

Corresponding author: Ruggero Dittadi, Laboratory Medicine Unit, Department of Clinical Pathology, Ospedale dell’Angelo, Azienda ULSS 3 Serenissima, Mestre, Via Paccagnella 11, 30174, Venice, Italy; and Regional Center for Biomarkers, Department of Clinical Pathology, Azienda ULSS 3 Serenissima, Venice, Italy, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

References

1. van Rossum, HH, Meng, QH, Ramanathan, LV, Holdenrieder, S. A word of caution on using tumor biomarker reference change values to guide medical decisions and the need for alternatives. Clin Chem Lab Med 2022;60:553–5. https://doi.org/10.1515/cclm-2021-0933.Search in Google Scholar PubMed

2. Coşkun, A, Aarsand, AK, Sandberg, S, Guerra, E, Locatelli, M, Díaz-Garzón, J, et al.. Within- and between-subject biological variation data for tumor markers based on the European Biological Variation Study. Clin Chem Lab Med 2022;60:543–52. https://doi.org/10.1515/cclm-2021-0283.Search in Google Scholar PubMed

3. Coşkun, A, Sandberg, S, Unsal, I, Cavusoglu, C, Serteser, M, Kilercik, M, et al.. Personalized reference intervals in laboratory medicine: a new model based on within-subject biological variation. Clin Chem 2021;67:374–84.10.1093/clinchem/hvaa233Search in Google Scholar PubMed

4. Dittadi, R, Peloso, L, Gion, M. Within-subject biological variation in disease: the case of tumour markers. Ann Clin Biochem 2008;45:226–7.10.1258/acb.2007.072441Search in Google Scholar PubMed

5. Ricós, C, Iglesias, N, Garcia-Lario, JV, Simon, M, Cava, F, Hernandez, A, et al.. Within-subject biological variation in disease: collated data and clinical consequences. Ann Clin Biochem 2007;44:343–52.10.1258/000456307780945633Search in Google Scholar PubMed

6. Aarsand, AK, Røraas, T, Fernandez-Calle, P, Ricos, C, Díaz-Garzón, J, Jonker, N, et al.. The biological variation data critical appraisal checklist: a standard for evaluating studies on biological variation. Clin Chem 2018;64:501–14.10.1373/clinchem.2017.281808Search in Google Scholar PubMed

7. Moritz, R, Muller, M, Korse, CM, van den Broek, D, Baas, P, van den Noort, V, et al.. Diagnostic validation and interpretation of longitudinal circulating biomarkers using a biomarker response characteristic plot. Clin Chim Acta 2018;487:6–14.10.1016/j.cca.2018.09.015Search in Google Scholar PubMed

8. Muller, M, Hoogendoorn, R, Moritz, RJG, van der Noort, V, Lanfermeijer, M, Korseb, CM, et al.. Validation of a clinical blood-based decision aid to guide immunotherapy treatment in patients with non-small cell lung cancer. Tumor Biol 2021;43:115–27.10.3233/TUB-211504Search in Google Scholar PubMed

9. Ceriotti, F, Fernandez-Calle, P, Klee, GG, Nordin, G, Sandberg, S, Streichert, T, et al.. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med 2017;55:189–94.10.1515/cclm-2017-0772Search in Google Scholar PubMed

10. Etzioni, RD, Ankerst, DP, Weiss, NS, Inoue, LY, Thompson, IM. Is prostate-specific antigen velocity useful in early detection of prostate cancer? A critical appraisal of the evidence. J Natl Cancer Inst 2007;99:1510–5.10.1093/jnci/djm171Search in Google Scholar PubMed

11. Connolly, D, Black, A, Murray, LJ, Napolitano, G, Gavin, A, Keane, PF. Methods of calculating prostate-specific antigen velocity Eur Urol 2007;52:1044–50.10.1016/j.eururo.2006.12.017Search in Google Scholar PubMed

12. Zhou, C, Clamp, A, Backen, A, Berzuini, C, Renehan, A, Banks, RE, et al.. Systematic analysis of circulating soluble angiogenesis-associated proteins in ICON7 identifies Tie2 as a biomarker of vascular progression on bevacizumab. Br J Cancer 2016;115, 228–35.10.1038/bjc.2016.194Search in Google Scholar PubMed PubMed Central

Received: 2022-01-18
Accepted: 2022-02-23
Published Online: 2022-03-10
Published in Print: 2022-05-25

© 2022 Walter de Gruyter GmbH, Berlin/Boston

Downloaded on 4.5.2024 from https://www.degruyter.com/document/doi/10.1515/cclm-2022-0047/html
Scroll to top button