Indication - HIV infection
Qualitative HIV nucleic acid test (NAT)
Facility level:
Assay formats
Point-of-care NAT
Status history
First added in 2018
Changed in 2020
Purpose type
To diagnose HIV infection in infants < 18 months of age
Specimen types
Capillary whole blood, Venous whole blood, Dried blood spots (DBS)
WHO prequalified or recommended products
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;
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.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.