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Disease/health condition - HIV infection
CD4 cell enumeration
Setting:
2. Laboratory
Tiered Testing Service:
Regional or provincial hospital with laboratory
Assay format
Flow cytometry
Information History
First added in 2018
Changed in 2020
Purpose type
Staging, Monitoring
Purpose
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
GMDN

66463

CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the CD4 cell marker in a clinical specimen, using a fluorescent activated cell sorting/ flow cytometry (FACS/Flow) method.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W0103080699

REAGENTS FOR FLOW CYTOMETRY - OTHER

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2020)‎. Consolidated guidelines on HIV testing services, 2019. World Health Organization. https://iris.who.int/handle/10665/336323
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A