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Disease/health condition - HIV infection
Qualitative HIV nucleic acid amplification test
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Low-complexity automated NAAT
Information History
First added in 2018
Changed in 2024
Purpose type
Diagnosis
Purpose
To diagnose HIV infection in infants < 18 months of age.
Specimen types
Capillary whole blood, Dried blood spots (DBS), Venous whole blood
WHO prequalified or recommended products
GMDN

48441

HIV1/HIV2 nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using a nucleic acid technique (NAT).

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
EMDN

W0105030405

HIV MULTIPLE - NA REAGENTS

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. (‎2019)‎. Toolkit: HIV molecular diagnostics toolkit to improve access to viral load testing and infant diagnosis: HIV treatment and care. World Health Organization. https://iris.who.int/handle/10665/325961 ; Organisation mondiale de la Santé. (‎2020)‎. Des tests de diagnostic moléculaire de l’infection à VIH destinés à améliorer l’accès à la mesure de la charge virale et au diagnostic du VIH chez le nourrisson. Organisation mondiale de la Santé. https://iris.who.int/handle/10665/331805 ; World Health Organization. (‎2021)‎. Guidelines: updated recommendations on HIV prevention, infant diagnosis, antiretroviral initiation and monitoring. World Health Organization. https://iris.who.int/handle/10665/340190
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.
N/A