FDA Issues Emergency Use Authorization for Multiplex Zika Virus Test
The ArboViroPlex test is named for the 4 arboviruses it targets and the real-time reverse transcription polymerase chain reaction technique it uses.
The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the CII-ArboViroPlex rRT-PCR Test. The ArboViroPlex test, developed by scientists at the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health, is the first multiplex assay that tests for viral RNA matching Zika virus, all serotypes of dengue virus, chikungunya virus, and West Nile virus simultaneously.
The EUA application was submitted to the FDA at the request of the National Institute of Allergy and Infectious Diseases (NIAID) for use in its multicountry Zika in Infants and Pregnancy (ZIP) study. The test is only authorized by the FDA under the EUA for use by laboratories certified under the United States Clinical Laboratory Improvement Amendments of 1988.
The ArboViroPlex test, named for the 4 arboviruses it targets and the real-time reverse transcription polymerase chain reaction technique it uses, can detect the viruses in up to 88 samples of blood in less than 2 hours and can also detect Zika virus in urine samples, according to a press release by CII.
“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, CII director in the press release.
FDA approves emergency use for multiplex Zika test [press release]. New York, NY: Columbia University Mailman School of Public Health. Published August 14, 2017. Accessed August 15, 2017.