Download

Disease/health condition - Endocrine disorders
Thyroid-stimulating hormone (TSH)
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Immunoassay
Information History
First added in 2020
Changed in 2024
Purpose type
Screening, Aid to diagnosis
Purpose
To screen for congenital hypothyroidism in newborns. To screen for hypothyroidism in patients with medical conditions where the incidence of hypothyroidism is higher than in the general population (e.g., type 1 diabetes mellitus). To aid in the diagnosis of hypothyroidism and hyperthyroidism.
Specimen types
Serum, Plasma, Capillary whole blood, Dried blood spots (DBS)
WHO prequalified or recommended products
N/A
GMDN

54383

Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)

A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) 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 2005-2024
EMDN

W0102041O

THYROID STIMULATING HORMONE

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
Hannon, Harry, Therrell, Brad & World Health Organization. Hereditary Diseases Programme. (‎1990)‎. Guidelines on the prevention and control of congenital hypothyroidism / prepared by Harry Hannon, Brad Therrell. World Health Organization. https://iris.who.int/handle/10665/59961
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