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

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.

Automated summary

Total testing process harmonization is essential for the effectiveness of laboratory medicine. This opinion paper examines the five phases of the TTP and summarizes the critical issues that arise in each phase, using SARS-CoV-2 serological tests as examples. Testing and screening of the population are crucial for defining seropositivity and guiding public health policies in managing the COVID-19 pandemic. However, differences in terminology, measurement units, reference ranges, and result interpretation parameters hinder comparability of analytical results, leading to general confusion. Through interdisciplinary work, the authors propose solutions to achieve effective total testing process harmonization, positively impacting the diagnostic effectiveness of laboratory tests.