Download
Disease/health condition -
Cardiovascular health
Troponin I
Assay format
Immunoassay
Information History
First added in 2018
Changed in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of acute myocardial infarction.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
54009
Troponin I IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using an enzyme immunoassay (EIA) 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 2005-2024EMDN
W01021306
TROPONIN I/T
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
WHO list of priority medical devices for management of cardiovascular diseases and diabetes. (2021). https://iris.who.int/handle/10665/341967
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