The FDA made the authorization on Monday for the CII-ArboViroPlex rRT-PCR Test developed by the Center for Infection and Immunity, or CII, at Columbia University's Mailman School of Public Health.
"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 in a press release.
The CII-ArboViroPlex rRT-PCR Test is the first multiplex test that can detect the Zika virus and all serotypes of dengue virus, chikungunya virus and West Nile virus simultaneously.
"The FDA decision to issue the EUA gives clinicians and researchers a powerful tool to diagnose and prevent the spread of Zika," W. Ian Lipkin, director of CII and professor of Epidemiology at the Mailman School of Public Health, said.
The authorization does not mean that the FDA has cleared or approved the CII-ArboViroPlex rRT-PCR Test, but has cleared it for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988. The authorization allows only for the detection of RNA form Zika, dengue, chikungunya and West Nile viruses, not other viruses or pathogens.
It authorized testing for patients who meet criteria from the Centers for Disease Control and Prevention, including history of residence or travel to a region with active Zika transmission.
The ArboViroPlex test can simultaneously detect the four viruses in up to 88 samples of blood in less than two hours and Zika in urine.