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Disease/health condition - HIV infection, Syphilis, Sexually transmitted infections (STIs)
Combined antibodies to Treponema pallidum and HIV 1/2
Setting:
1. Non-laboratory
Tiered Testing Service:
Primary health care center without laboratory District hospital with laboratory
Assay format
Lateral flow RDT
Information History
First added in 2018
Changed in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of Treponema pallidum and HIV 1/2.
Specimen types
Capillary whole blood, Serum, Plasma
WHO prequalified or recommended products
GMDN

63667

HIV1/HIV2/Treponema pallidum antibody 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 antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) and Treponema pallidum, the bacteria associated with syphilis, 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
WHO supporting publications
World Health Organization. (‎2023)‎. Laboratory and point-of-care diagnostic testing for sexually transmitted infections, including HIV. World Health Organization. https://iris.who.int/handle/10665/374252
Technical specifications
This tool presents technical specifications for 15 IVD tests for syphilis. To review the one(s) of your interest 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.
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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.
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The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
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