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Indication -
HIV infection
Antibodies to HIV-1/2 (anti-HIV Ab)
Assay formats
Immunoassay
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 > 18 months of age
Specimen types
Serum, Plasma
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 (July 2015) https://apps.who.int/iris/handle/10665/179870;
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
Codes
ICD11 code:
1C62.Z
Summary of SAGE IVD recommendation
The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.