FDA Approves Emergency Use for Multiplex Zika Test
The Center for Infection and Immunity (CII) at Columbia University’s Mailman School hasannounced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the CII-ArboViroPlex rRT-PCR Test, 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. Available for immediate use in clinical and research settings, the test was developed by CII scientists and an EUA application was submitted to 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,” says Nischay Mishra, the lead project scientist and associate research scientist at CII.
“The FDA decision to issue the EUA gives clinicians and researchers a powerful tool to diagnose and prevent the spread of Zika,” adds W. Ian Lipkin, director of CII and the John Snow Professor of Epidemiology at the Mailman School of Public Health.
Lipkin, Mishra, and CII colleagues Thomas Briese and Rafal Tokarz are named on a pending international patent application for the technology.
ABOUT THE CII-ARBOVIROPLEX RRT-PCR TEST
The CII-ArboViroPlex rRT-PCR Test is an assay that detects viral RNA matching Zika virus (ZIKV), dengue virus types 1-4 (DENV), chikungunya virus (CHIKV), and West Nile virus (WNV) with a human housekeeping gene, viral RNA controls, and extraction controls that ensure the integrity of the test from nucleic extraction to the final result. Named for the four arboviruses it targets and the real-time reverse transcription polymerase chain reaction (rRT-PCR) technique it employs, the test can simultaneously detect ZIKV, DENV, CHIKV, and WNV in up to 88 samples of blood in less than two hours and ZIKV in urine (collected alongside a patient-matched serum specimen). Under the EUA, testing is authorized for patients meeting CDC Zika virus clinical criteria (e.g., signs and symptoms associated with ZIKV infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active ZIKV transmission at the time of travel, or other epidemiologic criteria for which ZIKV testing may be indicated) to aid in the diagnosis of ZIKV infection. The test, the manufacture of which will be overseen by CII, is authorized to be performed with the NucliSENS® easyMag® automated extraction platform (bioMérieux), the RNA UltraSense™ One-Step Quantitative RT-PCR System (Thermo Fisher), and CFX96 Real-Time PCR Detection System (Bio-Rad).