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FDA: Zika, arbovirus test approved for emergency use
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The FDA has authorized the ArboViroPlex rRT-PCR Test — a multiplex assay that can simultaneously test for Zika virus, all dengue virus serotypes, chikungunya virus and West Nile virus — for emergency use.
Developed by scientists at the Center for Infection and Immunity at Columbia University’s Mailman School of Public Health, this multiplex test is intended for use in the Zika in Infants and Pregnancy study, an international study launched by the National Institutes of Health to examine the health risks that Zika virus poses to pregnant women and their infants.
“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, PhD, lead project scientist and associate research scientist at the Center for Infection and Immunity at Columbia University’s Mailman School of Public Health, said in a release.
The ArboViroPlex rRT-PCR Test can be used to match the viral RNA to the four mosquito-borne illnesses through the use of a human housekeeping gene, viral RNA controls and extraction controls that promote reliability from extraction of samples to the result. This test can be used to detect dengue virus, chikungunya virus and West Nile virus on up to 88 samples of blood in under 2 hours, as well as Zika virus in urine, which is to be collected alongside a serum specimen from the same patient.
The emergency use authorization allows the test to be administered to those with clinical symptoms of Zika, as defined by the CDC or epidemiological criteria, including history of residence in or travel to an area with active Zika virus transmission.
“The FDA decision to issue the emergency use authorization gives clinicians and researchers a powerful tool to diagnose and prevent the spread of Zika,” W. Ian Lipkin, MD, director of the Center for Infection and Immunity and the John Snow Professor of Epidemiology at the Mailman School of Public Health, said in the release. – by Katherine Bortz