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Disease/health condition -
Measles, Vaccine-preventable diseases
Measles IgM antibodies
Assay format
Immunoassay
Information History
First added in 2020
Purpose type
Diagnosis
Purpose
To diagnose clinically suspected measles infection.
Specimen types
Serum, Plasma, Dried blood spots (DBS), Oral fluid
WHO prequalified or recommended products
N/A
GMDN
49280
Measles 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 Measles 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
W0105040703
MEASLES 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 including the measles IgM test category in the third EDL:
• as a disease-specific IVD for use in clinical laboratories (EDL 3, Section II.b, Vaccine-preventable diseases);
• using an immunoassay format;
• to diagnose clinically suspected measles infection.
• as a disease-specific IVD for use in clinical laboratories (EDL 3, Section II.b, Vaccine-preventable diseases);
• using an immunoassay format;
• to diagnose clinically suspected measles infection.
Measles is a highly infectious disease of public health concern, and eradication requires concerted effort to identify outbreaks and stop chains of transmission. Despite being a common and severe condition, there is currently no test category listed for measles in the EDL.
Detection of measles IgM is part of the case definition within WHO guidelines and is already established as the gold standard method for diagnosing acute measles. It is especially critical for confirming cases in an outbreak context. SAGE IVD noted that in all settings the test should be reserved for people with clinically suspected measles and is not appropriate as a screening tool for asymptomatic patients.
The reviews submitted show that the test has good clinical accuracy and performance.
SAGE IVD members acknowledged that the test is available in some RDT formats; but this application is only considering an EIA format for use in clinical laboratories. To that end, the group noted that the test is technically easy
to perform by laboratory technicians with basic training but it does require a laboratory with ambient environmental conditions and a regular power supply; moreover, it may be costly in LMICs and resource-constrained settings
(although it is still cheap compared with PCR tests).
IgM is part of the standard diagnosis of measles; it is often part of the reference standard; and it is recommended in WHO guidelines. There are no studies comparing the results of this test against an independent reference standard (given that it is effectively part of the case definition). The test is embedded in WHO protocols for testing for measles.
Many clinical cases are confirmed by a positive IgM. Evidence supporting the inclusion of IgM is largely based on experience that it confirms a measles diagnosis in most cases outside elimination settings.
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