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Disease/health condition -
Cancer
Total prostate-specific antigen (tPSA)
Assay format
Immunoassay
Information History
First added in 2019
Changed in 2024
Purpose type
Aid to diagnosis, Prognosis, Monitoring
Purpose
To aid in diagnosis, prognosis and monitoring of prostate cancer.
Specimen types
Venous whole blood
WHO prequalified or recommended products
N/A
GMDN
54664
Total prostate specific antigen (tPSA) 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 total prostate specific antigen (tPSA) 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
W0102030113
TOTAL PROSTATIC SPECIFIC ANTIGEN
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. (2017). WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended that the test for determination of total PSA be included on the EDL, based on the evidence for its use as an aid in the diagnosis of prostate cancer and for prognosis and monitoring. The Group noted that the
test is not suitable for use in screening or for a definitive diagnosis. The Group recommended that rapid, semi-quantitative point-of-care tests for use in primary care be evaluated at a future meetings. Recommended test purpose: as an aid in the diagnosis, prognosis and monitoring of prostate cancer.
PSA is recommended for use in the diagnosis of prostate cancer and in risk stratification and surveillance. The levels of evidence for these recommendations are considered to be moderate to high.
PSA has a stated role in prognostic models for recurrence, in the diagnostic workup of symptomatic patients and in post-treatment surveillance, as per the supporting evidence (available at: https://iris.who.int/handle/10665/329527)
World Health Organization. (2019). The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (including the second WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/329527