Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2

Objectives In scenarios of vaccine scarcity or contexts of organizational complexity, it is necessary to define prioritization strategies for allocating vaccine doses in compliance with the criterion of equity and efficiency of health resources. In this context, the COVIDIAGNOSTIX project, based on the health technology assessment (HTA), assessed the role of SARS-CoV-2 serological tests as a companion diagnostic in the definition of the vaccination strategies for the vaccine administration. To guarantee evidence support for health policy choices, two different vaccine strategies were analyzed, one based on administering the vaccine booster dose to the entire population (VACCINE strategy) and the other based on allocation criteria (TEST&VACCINE strategy). Methods The decision-oriented HTA (DoHTA) method, integrated with specific modeling and simulation techniques, helped define the perimeter to make health policy choices. Results The processing of the scores attributed to the key performance indicators concerning all the evaluation domains shows a performance of 94.34% for the TEST&VACCINE strategy and 83.87% for the VACCINE strategy. Conclusions TEST&VACCINE strategy can be the most advantageous in various scenarios due to greater speed from an operational and an economic point of view. The assessment schemes defined by COVIDIAGNOSTIX (i.e., technologies/intended use/settings) can easily and quickly be exported and adapted to respond to similar health "policy questions".