Indication - HIV infection
CD4 cell enumeration
Facility level:
Assay formats
Point-of-care flow cytometry platform
Status history
First added in 2018
Changed in 2020
Purpose type
Staging, Monitoring
For staging of advanced HIV disease; To monitor response to antiretroviral therapy (in settings where HIV viral load is not available)
Specimen types
Capillary whole blood, Venous whole blood
WHO prequalified or recommended products
WHO supporting documents
Consolidated guidelines on HIV testing services (December 2019) https://www.who.int/publications/i/item/978-92-4-155058-1 ; Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy (2017) https://apps.who.int/iris/handle/10665/255884/ ; https://www.who.int/health-topics/hiv-aids/#tab=tab_1
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.