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Disease/health condition - HIV infection
Antibodies to HIV 1/2 (anti-HIV 1/2)
Setting:
1. Non-laboratory
Tiered Testing Service:
N/A
Assay format
Self-testing
Information History
First added in 2018
Changed in 2024
Purpose type
Aid to diagnosis
Purpose
HIV self-testing to aid in the diagnosis of HIV infection.
Specimen types
Capillary whole blood, Oral fluid
WHO prequalified or recommended products
GMDN

65848

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
* lateral flow test
EMDN

W0105090302

HIV 1/2 - RT & POC

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2016)‎. Guidelines on HIV self-testing and partner notification: supplement to consolidated guidelines on HIV testing services. World Health Organization. https://iris.who.int/handle/10665/251655
Technical specifications
N/A
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A