Indication - HIV infection
Quantitative HIV nucleic acid test (NAT)
Facility level:
Assay formats
Status history
First added in 2018
Changed in 2020
Purpose type
Diagnosis, Monitoring
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
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
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.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.