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Indication -
HIV infection
Quantitative HIV nucleic acid test (NAT)
Assay formats
NAT
Status history
First added in 2018
Changed in 2020
Purpose type
Diagnosis, Monitoring
Purpose
To monitor response to antiretroviral treatment;
To diagnose HIV infection in infants < 18 months of age (only if validated by the manufacturer)
Specimen types
Dried blood spots (whole blood or plasma), 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=61
WHO supporting documents
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (2016) https://apps.who.int/iris/handle/10665/208825;
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
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.