COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection.
Int J Technol Assess Health Care
; 37(1): e87, 2021 Sep 22.
Article
in English
| MEDLINE | ID: covidwho-1434040
ABSTRACT
OBJECTIVE:
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.METHODS:
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.RESULTS:
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.CONCLUSIONS:
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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Serologic Tests
/
COVID-19 Testing
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
/
Reviews
/
Systematic review/Meta Analysis
Limits:
Humans
Language:
English
Journal:
Int J Technol Assess Health Care
Journal subject:
Health Services Research
Year:
2021
Document Type:
Article
Affiliation country:
S0266462321000441
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