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FDA Grants EUA for Columbia University's Zika Test

NEW YORK (GenomeWeb) – Columbia University's Mailman School of Public Health today announced the US Food and Drug Administration granted emergency use authorization for the CII-ArboViroPlex rRT-PCR test for the simultaneous detection of the Zika virus, along with other similar Flaviviruses.

The test, developed by the Center for Infection and Immunity at the Mailman school, can simultaneously detect for Zika, along with all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene that ensures the accuracy of the result. It is immediately available for use in clinical and research settings, Columbia said.

The test can simultaneously detect the viruses in up to 88 samples of blood in less than two hours. It can also be used with urine samples for Zika. Under EUA, testing is authorized for patients who meet the US Centers for Disease Control and Prevention's Zika virus clinical criteria, and/or CDC Zika virus epidemiological criteria.

The test is authorized for use with BioMérieux's NucliSens easyMag automated extraction platform, Thermo Fisher Scientific's RNA UltraSense One-Step Quantitative RT-PCR System, and Bio-Rad Laboratories' CFX96 Real-Time PCR detection system.

Earlier this month, the FDA granted an EAU for Thermo Fisher Scientific's TaqPath Zika Virus Kit.