COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection

ABSTRACT

Background In vitro diagnostic tests for SARS-COV2 have rapidly spread. However mostly single-center technical and diagnostic performance's evaluations have been carried out without an intralaboratory validation process and a HTA systematic approach. Therefore, the HTA for evaluating antibody tests for SARS-COV-2 was applied and the following objectives have been pursued -Comparison of tests through the antibody titer in the SARS-CoV-2 vaccination campaign. -Assessment of the strategy implemented in the SARSCoV- 2 vaccination campaign. Materials & Methods A multidisciplinary team conducted the HTA following the DoHTA method. The three methodological and analytical steps used in the HTA were the selection of the tests to be evaluated;the research and collection of information to support the adoption and appropriateness of the technology;and the drafting of the final report which allows its dissemination and communication. In addition, alternative vaccination strategies were evaluated through the application of an algorithm that takes into account the ability to reduce the number of deaths and general containment of the pandemic. Results Serological tests allow to evaluate antibody response at different time points. In particular, disaggregating the data by sex and by age shows that the antibody response is high in women <48 years and is lower in men >60 years. The algorithm showed a better performance of the TEST&VACCINE strategy compared to the VACCINE strategy (94.34%vs 83.87%). Conclusions Thanks to the availability of real world data relating to the serological analysis it was possible to investigate the evolution of the antibody response to vaccination against SARS-CoV-2 in a large cohort of subjects, and the possibility of a harmonization process of the serological laboratory data, through the use of a conversion factor. Finally, the possibility of defining differential temporal priorities in the target population constitute an important element in optimizing the vaccination campaign, due to the ability to reduce the number of deaths and general containment of the pandemic.