La variabilità biologica e gli indicatori di neoplasia: un update (2022)

The assessment of biological variability (BV) of tumour markers is of particular interest to laboratory medicine professionals who are frequently consulted for their opinion or interpretation of a result compared to one or more previous values. In the database maintained by Ricos et al. were reported intra-subject biological variability (CVI) values of several tumour markers which had been often obtained with outdated instrumentation and reported in articles dated and of limited impact. For example, the CVI values of the tumour markers most frequently requested in clinical laboratories in the data-base maintained by Ricos et al. and available on Westgard‘s website through 2018 were obtained from sixteen articles (ten for CEA, five for CA 15-3, four for CA 125, three for PSA and two for CA 19-9); five of these references were conference abstracts, one was a dissertation, and only four had been published after 2000. The limits of the data-base had been pointed out and correctives such as checklists were proposed to standardize the evaluation of articles and multicenter studies were planned that would comply with them and allow for calculating more correctly CVI in order to generate a new BV data-base. The European Federation of Clinical Chemistry and Laboratory Medicine made this very challenging commitment in 2014. It must be acknowledged (and known) that as of 2015 the work done has been truly relevant and laboratory medicine professionals from our country have played a significant role. A real open-air mine of what has been unearthed and what is still being excavated is now available. This review aims to document which aspects have been clarified and corrected and which ones remain undefined (for example, the comparability of CVI in the healthy subject and that in the subject with cancer and other severe non-neoplastic disease). Finally, the main points related to the state of the art on the BV and indicators of neoplasia have been summarized.