Export
Indication -
HIV infection
HIV 1/2 antibody (anti-HIV Ab)
Assay formats
RDT
Status history
First added in 2018
Changed in 2020
Purpose type
Aid to diagnosis
Purpose
HIV self-testing to aid in the diagnosis of HIV infection
Specimen types
Oral fluid, Capillary whole blood
WHO prequalified or recommended products
Public reports of WHO prequalified IVDs https://extranet.who.int/pqweb/vitro-diagnostics/prequalification-reports/whopr?field_whopr_category=60
WHO supporting documents
Consolidated guidelines on HIV testing services (December 2019) https://www.who.int/publications/i/item/978-92-4-155058-1 ;
Guidelines on HIV self-testing and partner notification (2016) https://apps.who.int/iris/handle/10665/251655;
WHO implementation tool for pre-exposure prophylaxis (PrEP) of HIV infection, module 10 for testing providers (2017) https://apps.who.int/iris/handle/10665/258516;
WHO HIV molecular diagnostics toolkit to improve access to viral load testing and infant diagnosis: Toolkit (July 2019) https://apps.who.int/iris/handle/10665/325961/ ; https://www.who.int/health-topics/hiv-aids/#tab=tab_1;
Codes
ICD11 code:
1C62.Z
Summary of SAGE IVD recommendation
The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.