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Indication -
HIV infection
Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag)
Status history
First added in 2018
Changed in 2020
Purpose type
Screening, Aid to diagnosis
Purpose
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
Public reports of WHO prequalified IVDs https://extranet.who.int/pqweb/vitro-diagnostics/prequalification-reports/whopr?field_whopr_category=58
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
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.