Are there any concerns regarding FDA or WHO prequalification approval prior to its use in PEPFAR countries?

Are there any concerns regarding FDA or WHO prequalification approval prior to its use in PEPFAR countries?

There are no concerns for use in PEPFAR given that the test is not used for clinical management nor will standard of care for newly diagnosed persons change based on recent infection status. Moreover, the new test is not part of the national testing algorithm. It will be used for real-time surveillance of new infections among persons who are confirmed HIV-positive per national testing guidelines and response efforts. There are plans for the RTRI to go through the WHO prequalification process for HIV diagnosis and recent infection testing, though this process is expected to take some time since currently recent infection testing is not part of the WHO prequalification portfolio.

Comment on this FAQ

Your email address will not be published. Required fields are marked *