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Disease/health condition -
Arboviral diseases, Zika virus infection
Zika virus nucleic acid amplification test
Assay format
NAAT
Information History
First added in 2019
Changed in 2020
Purpose type
Diagnosis
Purpose
To diagnose acute zika virus infection (within the first week of infection).
Specimen types
Cerebrospinal fluid, Serum, Plasma, Urine, Venous whole blood
WHO prequalified or recommended products
N/A
GMDN
49102
Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Zika virus in a clinical specimen, using a nucleic acid technique (NAT).
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
W0105040531
ZIKA VIRUS - NA REAGENTS
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 inclusion on the EDL of the test for ZIKV nucleic acid for diagnosis or confirmation of early ZIKV infection, noting that it is specific for confirming infection and detecting outbreaks; its sensitivity and specificity appear to be acceptable. There is no cross-reactivity with other flaviviruses.
The Group noted, however, that no studies of use in the field have been reported. Use of NAT for diagnosis of ZIKV infection is included in WHO laboratory guidance published in 2016 and in updated guidance by the WHO Regional Office for the Americas in 2018.
The Group also recommended that simple NAT tests be developed for use in primary care settings or in district hospitals.
Recommended test purpose: to diagnose acute ZIKV infection.
The importance of monitoring and controlling ZIKV transmission globally was underscored when WHO declared ZIKV infection and its associated complications a PHEIC. Several studies have shown valid results of ZIKV NAT tests in patients with acute infection, pregnant women, fetal deaths (stillbirths) and children born with neurological and other congenital clinical outcomes, as confirmed by PCR methods. Studies in selected, sometimes artificial samples provide some evidence for the accuracy of ZIKV NAT tests.
Two tests have published small evaluation studies which show agreement with confirmed PCR methods. Studies have been undertaken in small stored sample banks or spiked sera.
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