Indication - HIV infection
CD4 cell enumeration
Facility level:
Assay formats
Flow cytometry
Status history
First added in 2018
Changed in 2020
Purpose type
Staging, Monitoring
To stage advanced HIV disease; To monitor response to antiretroviral therapy (in settings where quantifying viral load is not available)
Specimen types
Capillary whole blood, Venous whole blood
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; Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy https://apps.who.int/iris/handle/10665/255884
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.