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Disease/health condition -
Arboviral diseases, Zika virus infection
IgM antibodies to zika virus
Assay format
Immunoassay
Information History
First added in 2019
Changed in 2020
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of suspected zika virus infection.* .
* Zika virus IgM test results should not be used alone for clinical decision-making in pregnancy
Specimen types
Serum
WHO prequalified or recommended products
N/A
GMDN
49106
Zika 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 Zika 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
W0105040630
ZIKA VIRUS
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. (2016). Laboratory testing for Zika virus infection: interim guidance. World Health Organization. https://iris.who.int/handle/10665/204671 ; Organización Mundial de la Salud. (2016). Pruebas de laboratorio para la infección por el virus de Zika: orientación provisional. Organización Mundial de la Salud. https://iris.who.int/handle/10665/204898 (Other languages available too) ; World Health Organization. (2025). WHO guidelines for clinical management of arboviral diseases: dengue, chikungunya, Zika and yellow fever. World Health Organization. https://iris.who.int/handle/10665/381804
Technical specifications
N/A
Related Medical Devices in MeDevIS
The SAGE IVD recommended conditional inclusion on the EDL of the ELISA for ZIKV anti-IgM, pending provision of further evidence, including a clear recommendation in guidelines and an updated review of the available data.
The Group noted that caution should be used in interpreting the results of ZIKV anti-IgM tests, particularly for pregnant women, in the absence of prior NAT testing. The Group noted the high level of cross-reactivity of anti-IgM with ZIKV, DENV and other flaviviruses, the wide range of specificity and the persistence of Zika IgM antibody, which might reflect infection before pregnancy.
False-negative and false-positive results may occur.
The test should be used only as an aid to diagnosis, with confirmation of positive tests, and should not be used on cerebrospinal fluid samples.
Recommended test purpose: as an aid in the diagnosis of suspected Zika virus infection.
The importance of monitoring and controlling ZIKV transmission globally was underscored when WHO declared ZIKV infection and its associated complications a PHEIC. The tests are currently available under an FDA Emergency Use Authorization. Reliable diagnostic testing is still limited, especially in resource-constrained settings. The availability of simple, affordable tests will improve detection of outbreaks, accurate diagnosis and appropriate strategies for prevention, patient care and disease control.
Zika IgM IVDs have not been extensively validated, and the existing studies have not been published. The evidence base for ZIKV anti-IgM tests is unclear. At least one of the tests has poor performance in patients who are not infected with ZIKV, posing a risk of misdiagnosing dengue.
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