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Disease/health condition -
Vaccine-preventable diseases, Rubella
Rubella IgM antibodies
Assay format
Immunoassay
Information History
First added in 2020
Purpose type
Diagnosis
Purpose
To diagnose active rubella infection or recent exposure.
Specimen types
Serum, Plasma, Dried blood spots (DBS), Oral fluid
WHO prequalified or recommended products
N/A
GMDN
50268
Rubella virus immunoglobulin M (IgM) 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 M (IgM) 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
W0105040103
RUBELLA VIRUS IGM
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 IgM 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 diagnose active rubella infection or recent exposure.
• as a disease-specific IVD for clinical laboratories (EDL 3; Section II.b,Vaccine-preventable diseases);
• using an immunoassay format;
• to diagnose active rubella infection or recent exposure.
Rubella IgM testing is a routine part of investigating possible infections, as indicated in WHO rubella surveillance standards. Screening for rubella serostatus is recommended, in certain countries, as part of standard prenatal screening if a pregnant woman has no record of past immunity and no proof of immunization. The use of rubella IVDs to ensure eventual eradication is key to reducing inequity globally. The submission does not include data quantifying the usefulness of the test. But SAGE IVD acknowledged that IgM testing is used as a standard diagnostic tool across the world and forms an integral part of the case definition for rubella. Furthermore, while not included in the submission, the recent literature includes a body of recommendations on assay accuracy that document and analyse decades of work with IgM assays.
Sensitive and specific assays for detection are available to match a wide range of laboratory and testing capacities.
Rubella IgM testing is a routine part of investigating possible infections, as indicated in WHO measles and rubella surveillance standards.
Little evidence was provided that quantifies the usefulness of the rubella IgM test. However, the GMRLN tests approximately 100 000 serum specimens annually using an IgM EIA, signalling the availability of data supporting the use of the 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