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Disease/health condition -
Cancer
Discipline -
Serology and Immunology
Human chorionic gonadotropin beta-subunit (beta-hCG)
Assay format
Immunoassay
Information History
First added in 2019
Changed in 2024
Purpose type
Determination of physiological status, Aid to diagnosis, Montoring
Purpose
To confirm pregnancy. To aid in the diagnosis and management of ectopic pregnancy, miscarriage and abortion.
To aid in the diagnosis and monitoring of gestational trophoblastic disease and germ cell tumours.
Specimen types
Serum
WHO prequalified or recommended products
N/A
GMDN
66845
Human chorionic gonadotropin beta-subunit 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 the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used for early detection of pregnancy, as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage), or as an indicator of trisomy 21 (Down syndrome) during pregnancy.
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
W0102050205
TOTAL HUMAN CHORIONIC GONADOTROPIN
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
Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health. (2016). https://iris.who.int/bitstream/handle/10665/205490/9789241565028_eng.pdf?sequence=1 ; Urinary and Male Genital Tumours WHO Classification of Tumours, 5th Edition, Volume 8, 2022. https://publications.iarc.who.int/Book-And-Report-Series/Who-Classification-Of-Tumours/Urinary-And-Male-Genital-Tumours-2022 ; Female Genital Tumours WHO Classification of Tumours, 5th Edition, Volume 4, 2020. https://publications.iarc.who.int/Book-And-Report-Series/Who-Classification-Of-Tumours/Female-Genital-Tumours-2020
Technical specifications
N/A
Related Medical Devices in MeDevIS
For pregnancy related recommendations: SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte. It was recognized that the test is a foundational IVD test and is included in clinical guidelines. For cancer related recommendations: the SAGE IVD recommended conditional inclusion on the EDL of the test for the sum of hCG and β-hCG for the diagnosis and surveillance of germ-cell tumours and gestational trophoblastic disease, and requested submission of more evidence of reference ranges for the general population of men and women in the countries and ethnic population in which the test will be used. The group proposed that proficiency testing or an external quality assurance programme be introduced to ensure local performance of the assay.
For cancer related recommendations: use of hCG for monitoring germ-cell tumours, which are generally diagnosed in young patients, permits classification of risk for advanced disease while it is still amenable to curative treatment and to adapt the treatment according to the level of hCG detected. The availability of hCG testing allows accurate treatment and prognosis of cancers, prescription of treatments listed in the WHO EML and avoidance of over-treatment. Moreover, the kinetics of hCG is associated with better prediction of resistance to treatment, as a basis for a timely change of the cytotoxic regimen.
For pregnancy related recommendations the inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test. For cancer related recommendations: although guideline recommendations for using the sum of hCG and β-hCG for the diagnosis and surveillance of germ-cell tumours and gestational trophoblastic disease are clear, the evidence upon which they are based was not evident in the submission. Evidence from trials was provided that showed that tailoring chemotherapy for the treatment of germ-cell tumours with an unfavourable decrease in tumour markers (based in part on hCG assessment) was beneficial and prognostic.
For cancer related recommendations: 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