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Licensed Unlicensed Requires Authentication Published by De Gruyter August 4, 2023

The total testing process harmonization: the case study of SARS-CoV-2 serological tests

  • Alessandra Colombini , Carla Divieto , Rossella Tomaiuolo ORCID logo EMAIL logo , Leonardo Mortati , Jessica Petiti , Chiara Di Resta and Giuseppe Banfi


The total testing process harmonization is central to laboratory medicine, leading to the laboratory test’s effectiveness. In this opinion paper the five phases of the TTP are analyzed, describing, and summarizing the critical issues that emerged in each phase of the TTP with the SARS-CoV-2 serological tests that have affected their effectiveness. Testing and screening the population was essential for defining seropositivity and, thus, driving public health policies in the management of the COVID-19 pandemic. However, the many differences in terminology, the unit of measurement, reference ranges and parameters for interpreting results make analytical results difficult to compare, leading to the general confusion that affects or completely precludes the comparability of data. Starting from these considerations related to SARS-CoV-2 serological tests, through interdisciplinary work, the authors have highlighted the most critical points and formulated proposals to make total testing process harmonization effective, positively impacting the diagnostic effectiveness of laboratory tests.

Corresponding author: Rossella Tomaiuolo, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy; and Vita-Salute San Raffaele University, 20132 Milan, Italy, E-mail:

Funding source: Ministero della Salute

Award Identifier / Grant number: COVID-2020-12371619

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

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

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

  5. Research funding: The study was funded by Ministero della Salute (COVID-2020-12371619).


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Received: 2023-04-06
Accepted: 2023-07-19
Published Online: 2023-08-04
Published in Print: 2023-11-27

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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