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

Ruggero Dittadi^{1

2}, Aline S C Fabricio³, Massimo Gion²

Affiliations

¹ Laboratory Medicine Unit, Department of Clinical Pathology, Ospedale dell'Angelo, Azienda ULSS 3 Serenissima, Mestre, Venice, Italy.
² Regional Center for Biomarkers, Department of Clinical Pathology, Azienda ULSS 3 Serenissima, Venice, Italy.
³ Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.

Comment

Ruggero Dittadi et al. Clin Chem Lab Med. 2022.

. 2022 Mar 10;60(6):e136-e137.

doi: 10.1515/cclm-2022-0047. Print 2022 May 25.

Ruggero Dittadi^{1

2}, Aline S C Fabricio³, Massimo Gion²

¹ Laboratory Medicine Unit, Department of Clinical Pathology, Ospedale dell'Angelo, Azienda ULSS 3 Serenissima, Mestre, Venice, Italy.
² Regional Center for Biomarkers, Department of Clinical Pathology, Azienda ULSS 3 Serenissima, Venice, Italy.
³ Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.

No abstract available

Keywords: biological variation; reference change value; tumor biomarker.

Comment on

Within- and between-subject biological variation data for tumor markers based on the European Biological Variation Study.
Coşkun A, Aarsand AK, Sandberg S, Guerra E, Locatelli M, Díaz-Garzón J, Fernandez-Calle P, Ceriotti F, Jonker N, Bartlett WA, Carobene A; European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation. Coşkun A, et al. Clin Chem Lab Med. 2021 May 10;60(4):543-552. doi: 10.1515/cclm-2021-0283. Print 2022 Mar 28. Clin Chem Lab Med. 2021. PMID: 33964202
A word of caution on using tumor biomarker reference change values to guide medical decisions and the need for alternatives.
van Rossum HH, Meng QH, Ramanathan LV, Holdenrieder S. van Rossum HH, et al. Clin Chem Lab Med. 2021 Oct 15;60(4):553-555. doi: 10.1515/cclm-2021-0933. Print 2022 Mar 28. Clin Chem Lab Med. 2021. PMID: 34648697 No abstract available.

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.
1. 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.
1. 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.
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1. 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.