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

ObjectiveIn 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 assessme...

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Bibliographic Details
Published in:International journal of technology assessment in health care 2021-09, Vol.37 (1), p.e87-e87, Article e87
Main Authors: Tomaiuolo, Rossella, Derrico, Pietro, Ritrovato, Matteo, Locatelli, Massimo, Milella, Frida, Restelli, Umberto, Lago, Paolo, Giuliani, Francesco, Banfi, Giuseppe
Format: Article
Language:English
Subjects:
Antibodies
Assessment
Asymptomatic
Automation
Clinical trials
Coronaviruses
COVID-19
Disease transmission
Health technology assessment
Immunoglobulins
Infections
Laboratories
Medical diagnosis
Medical personnel
Medical research
New technology
Patient safety
Proteins
Reagents
Serological tests
Serology
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Systematic review
Technology assessment
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Summary:ObjectiveIn 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.
ISSN:0266-4623
1471-6348
DOI:10.1017/S0266462321000441