L'Auto-test de détection du VIH
L'OMS a préqualifié aujourd'hui le premier auto-test de détection du VIH dans
le but d'augmenter le diagnostic et le traitement du VIH.
Le produit, l'auto-test OraQuick ® HIV (fabriqué par OraSure Technologies Inc.)
utilise du liquide oral comme spécimen et fournit des résultats aussi peu que
HIV self-test WHO today prequalified the first HIV self-test in a move to
increase HIV diagnosis and treatment.
The product, OraQuick ® HIV Self-Test (manufactured by OraSure Technologies
Inc.) uses oral fluid as a specimen and provides results in as little as twenty
“The prequalification of this product means that countries with poor laboratory
infrastructure will be able to safely increase testing capacity, thereby
facilitating treatment of people living with HIV,” said Dr Suzanne Hill,
Director, Essential Medicines and Health Products, WHO.
The move also marks a significant step in allowing countries to implement WHO
guidelines, released in 2016, recommending HIV self-testing as a complementary
approach to reach those who remain undiagnosed due to fear of stigma and
“Over the past year, the number of countries incorporating HIV self-testing
into their policies has increased from 16 to 40. This is impressive progress,”
said Dr Gottfried Hirnschall, WHO’s Director of the HIV Department. “Having
quality-assured self-tests is essential to enable countries to implement more
rapidly. It is a positive step towards making innovative HIV self-testing
accessible to all those who would benefit from it.”
In 2016, an estimated 30% of all people living with HIV remained unaware of
their HIV status, many from higher risk populations who are either less likely
to approach a health facility or are unable to do so.
“As the first HIV self-testing product to obtain WHO prequalification, this is
a major step that will help give governments the confidence they need to adopt
and scale up use of self-testing,” said Philippe Duneton, Deputy Executive
Director of Unitaid.
There is currently great interest from the international community in deploying
tests intended for HIV self-testing, with numerous countries having developed
national guidelines and plans for implementation. Support for procurement and
deployment of these tests has been pledged by most major international
financing and procurement agencies, including a specific agreement on
affordable pricing for 50 lower-middle income countries in Africa and Asia
between the manufacturer and the Bill and Melinda Gates Foundation, a funder of
WHO list of prequalified in vitro diagnostic products
WHO Prequalification of In Vitro Diagnostics
PrequalificationWHO Prequalification assures the quality, safety and efficacy
of priority medicines, vaccines and in vitro diagnostics bought by
international procurers for low-income countries. This is achieved through
rigorous assessment of products and inspection activities, building national
capacity for manufacture and working with regulators to register those products
quickly. Prequalification is now increasingly used by countries.