Indication - HIV infection
Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag)
Facility level:
Assay formats
Status history
First added in 2018
Changed in 2020
Purpose type
Screening, Aid to diagnosis
To screen for or to aid in the diagnosis of HIV infection: adults, adolescents, children and infants > 8 months of age
Specimen types
Capillary whole blood, Venous whole blood
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

General In vitro diagnostics tests are the general core and routine laboratory tests for clinical chemistry, haematology, blood transfusion, microbiology (virology, bacteriology, parasitology and mycology) and histopathology. These tests were selected on the basis of the scientific validity of an analyte, i.e. the association between an analyte and a clinical condition or physiological state; and clinical utility. Many of these tests are required for effective management of patients and have already been described in WHO publications.

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.