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Disease/health condition -
HIV infection, Meningitis
Cryptococcal antigen
Assay format
Lateral flow RDT
Information History
First added in 2018
Changed in 2020
Purpose type
Screening, Diagnosis
Purpose
To screen for and diagnose cryptococcal meningitis in people with advanced HIV disease.
Specimen types
Capillary whole blood, Venous whole blood
WHO prequalified or recommended products
N/A
GMDN
65815
Cryptococcus complex species antigen IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from yeast species of the Cryptococcus complex (e.g., C. neoformans, C. gattii) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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* lateral flow test
EMDN
W010509
INFECTIOUS IMMUNOLOGY - RAPID TESTS & POINT OF CARE
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/emdnWHO supporting publications
World Health Organization. (2018). Guidelines for the diagnosis, prevention, and management of cryptococcal disease in HIV-infected adults, adolescents and children, March 2018: supplement to the 2016 consolidated guidelines of the use of antiretroviral drugs for treating and preventing HIV infection. World Health Organization. https://iris.who.int/handle/10665/260399
Technical specifications
This tool presents technical specifications for one IVD test for Cryptococcal antigen RDT. To review it, download the file and go to the “Test menu” tab to make your selection. You will find more details in the “Content” tab of this file.
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