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Disease/health condition -
Vaccine-preventable diseases, Rubella
Rubella IgG antibodies
Assay format
Immunoassay
Information History
First added in 2020
Purpose type
Screening
Purpose
To screen for prior exposure to rubella infection or vaccination, particularly in pregnant women.
Specimen types
Serum, Plasma, Dried blood spots (DBS), Oral fluid
WHO prequalified or recommended products
N/A
GMDN
50265
Rubella virus immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Rubella virus 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
W0105040102
RUBELLA VIRUS IGG
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. (2007). Manual for the laboratory diagnosis of measles and rubella virus infection, 2nd ed. World Health Organization. https://iris.who.int/handle/10665/70211 ; World Health Organization. (2008). Immunological basis for immunization : rubella. World Health Organization. https://iris.who.int/handle/10665/43922
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended the inclusion of the rubella IgG antibody test category in the third EDL:
• as a disease-specific IVD for clinical laboratories (EDL 3; Section II.b, Vaccine-preventable diseases);
• using an immunoassay format;
• to screen for prior exposure to rubella infection or vaccination, particularly in pregnant women. The group further recommended securing the requisite evidence to enable an additional test purpose for the rubella IgG antibody test category of diagnosing acute infection.
• as a disease-specific IVD for clinical laboratories (EDL 3; Section II.b, Vaccine-preventable diseases);
• using an immunoassay format;
• to screen for prior exposure to rubella infection or vaccination, particularly in pregnant women. The group further recommended securing the requisite evidence to enable an additional test purpose for the rubella IgG antibody test category of diagnosing acute infection.
The elimination of rubella is a global priority and requires a concerted effort to identify outbreaks and stop chains of transmission. The rubella IgG test can help by identifying immunity to rubella and preventing congenital rubella syndrome (CRS), and is particularly useful for screening pregnant women. IgG testing forms part of the case definition for rubella and is an important decision-making tool that is widely used in vaccination strategies, both to identify whom to vaccinate and to assess the success of individual campaigns.
This class of IVDs offer good quality, safety and performance for detecting IgG antibodies to rubella virus. A broad range of products are available at all levels, from small, low-tech laboratories to high-throughput commercial laboratories.
Some specific questions remain about the test’s use in very low incidence settings, but these do not negate the overall value of the test for preventing CRS.
WHO guidelines suggest that rubella IgG testing could also be useful as an additional serologic method for case classification, although the submission to the EDL 3 did not include any data to support this test purpose.
Assessment of the accuracy of different tests is challenging, as there is no independent reference standard. Cited studies may be better viewed as assessing equivalence between different tests rather than accuracy.
IgG testing has been shown to be important in vaccination campaigns, both to identify who requires vaccination and to assess the success of campaigns. These include national programmes and institute programmes such as in-hospital staff. There is thus evidence of the clinical utility of the IgG test.
World Health Organization. (2021). The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (including the third WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/339064