FDA issues Emergency Use Authorization for multiplex Zika test

The U.S. Food and Drug Administration (FDA) recently issued an Emergency Use Authorization (EUA) for the CII-ArboViroPlex rRT-PCR Test.

The test is the first multiplex assay that simultaneously tests for the presence of Zika virus, all serotypes of dengue virus, chikungunya virus and West Nile virus as well as a host gene that ensures the accuracy of results.

The multiplex test is immediately available for use in clinical and research settings.

“The FDA decision to issue the EUA gives clinicians and researchers a powerful tool to diagnose and prevent the spread of Zika,” said W. Ian Lipkin, director of the Center for Infection and Immunity (CII) and the John Snow Professor of Epidemiology at the Mailman School of Public Health.

CII scientists developed the test and submitted an EUA application to the FDA at the request of the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) for use in its multi-country Zika in Infants and Pregnancy (ZIP) study.

“The ArboViroPlex Test provides an easy and efficient means to simultaneously detect Zika and three other mosquito-borne viral infections that may present with similar clinical features,” Nischay Mishra, the lead project scientist and associate research scientist at CII, said.