Abstract：
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.
摘要：
整个测试过程的统一是实验室医学的核心，导致实验室测试的有效性。本文分析了TTP的五个阶段，描述，并总结了SARS-CoV-2血清学测试在TTP每个阶段出现的影响其有效性的关键问题。检测和筛查人群对于定义血清阳性和，因此，在COVID-19大流行的管理中推动公共卫生政策。然而,术语的许多差异，计量单位,解释结果的参考范围和参数使分析结果难以比较，导致影响或完全排除数据可比性的普遍混乱。从SARS-CoV-2血清学检测相关的这些考虑出发,通过跨学科的工作，作者强调了最关键的要点，并提出了使整体测试过程协调有效的建议，积极影响实验室测试的诊断有效性。
