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Discipline - Serology and Immunology
Human chorionic gonadotropin beta-subunit (beta-hCG)
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 2020
Purpose type
Determination of physiological status
Purpose
To aid in the early detection of pregnancy.
Specimen types
Urine
WHO prequalified or recommended products
N/A
GMDN

66850

Human chorionic gonadotropin beta-subunit 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 the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) 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 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. 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
EMDN

W0102160302

HCG - RT & POC

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
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
Technical specifications
N/A
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.
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