Abstract
In vitro diagnostic tests for SARS-COV-2, also known as serological tests, have rapidly spread. However, to date, mostly single-center technical and diagnostic performance's assessments have been carried out without an intralaboratory validation process and a health technology assessment (HTA) systematic approach. Therefore, the rapid HTA for evaluating antibody tests for SARS-COV-2 was applied. The use of rapid HTA is an opportunity to test innovative technology. Unlike traditional HTA (which evaluates the benefits of new technologies after being tested in clinical trials or have been applied in practice for some time), the rapid HTA is performed during the early stages of developing new technology. A multidisciplinary team conducted the rapid HTA following the HTA Core Model® (version 3.0) developed by the European Network for Health Technology Assessment. The three methodological and analytical steps used in the HTA applied to the evaluation of antibody tests for SARS-COV-2 are reported: 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 preparation of the final reports and their dissemination. Finally, the rapid HTA of serological tests for SARS-CoV-2 is summarized in a report that allows its dissemination and communication. The rapid-HTA evaluation method, in addition to highlighting the characteristics that differentiate the tests from each other, guarantees a timely and appropriate evaluation, becoming a tool to create a direct link between science and health management.
Highlights
COVID-19 disease, caused by the coronavirus SARS-CoV-2, has gradually spread around the world since the last months of 2019 [1]
The synthesis of antibodies is a primary immune response to infections [4]: immunoglobulin A (IgA) responses appear between 4 and 10 days after infection; immunoglobulin M (IgM) levels rise during the first week after SARS-CoV-2 infection, peak after 2 weeks, and return to near-background levels in most individuals; immunoglobulin G (IgG) is detectable after 1 week and is kept at a high level for an extended period
By retracing the methodological and analytical phases, we report the rapid health technology assessment (HTA) related to the serological tests of SARS-CoV-2 evaluated and validated in the Covidiagnostix project
Summary
COVID-19 disease, caused by the coronavirus SARS-CoV-2, has gradually spread around the world since the last months of 2019 [1]. The first step in diagnosing SARS-CoV-2 infection is RT-PCR, which detects viral nucleic acids present in nasopharyngeal fluids, allowing viral detection in asymptomatic infected individuals [3]. Known as serological tests, detect the presence of antibodies produced in response to SARS-CoV-2 infection and reveal past infections by identifying antibodies. The synthesis of antibodies is a primary immune response to infections [4]: immunoglobulin A (IgA) responses appear between 4 and 10 days after infection; immunoglobulin M (IgM) levels rise during the first week after SARS-CoV-2 infection, peak after 2 weeks, and return to near-background levels in most individuals; immunoglobulin G (IgG) is detectable after 1 week and is kept at a high level for an extended period.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: International Journal of Technology Assessment in Health Care
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
