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Disease/health condition -
HIV infection
Antibodies to HIV 1/2 (anti-HIV 1/2)
Assay format
Immunoassay
Information History
First added in 2018
Changed in 2024
Purpose type
Screening, Aid to diagnosis
Purpose
To screen for or to aid in the diagnosis of HIV infection in adults, adolescents, children and infants > 18 months of age. To screen blood donations for HIV.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
GMDN
48451
HIV1/HIV2 antibody IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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 2005-2024EMDN
W0105030402
HIV MULTIPLE ANTIBODY
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/emdnWHO supporting publications
World Health Organization. (2020). Consolidated guidelines on HIV testing services, 2019. World Health Organization. https://iris.who.int/handle/10665/336323 ;
World Health Organization. (2017). WHO implementation tool for pre-exposure prophylaxis (PrEP) of HIV infection: module 10: testing providers. World Health Organization. https://iris.who.int/handle/10665/258516 ; World Health Organization. (2009). Screening donated blood for transfusion-transmissible infections : recommendations. World Health Organization. https://iris.who.int/handle/10665/44202
Technical specifications
N/A
Related Medical Devices in MeDevIS
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.
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The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
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