FDA Approves Emergency Use for Multiplex Zika Test
The Center for Infection and Immunity (CII) at Columbia University’s Mailman School today announced 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.
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).
About Emergency Use Authorization Status
The CII-ArboViroPlex rRT-PCR Test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. The test has been authorized only for the detection of RNA from ZIKV, DENV, CHIKV, and WNV, and diagnosis of corresponding infections, not for any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Several Zika virus outbreaks have occurred in the past few years including the current outbreak ongoing in Brazil and a number of other Central and South American countries. In 2015, the number of suspected Zika virus cases in Brazil was estimated to be between 440,000 and 1.3 million. By February 2017, locally-transmitted cases had been reported from 50 countries and territories in the Americas, including U.S. and U.S. territories, 10 countries and territories in Asia, Oceania, and Pacific islands, and 1 country in Africa. Due to the increasing evidence of a correlation between Zika virus infection and (1) the incidence of Guillain-Barré syndrome and (2) poor pregnancy outcomes, including the development of microcephaly in the fetus or infant, the importance of diagnosing a Zika virus infection is rapidly increasing. Zika virus is primarily transmitted by mosquitoes (including Aedes aegypti). In addition, mother-to-fetus and sexually transmitted infections have been documented. Most cases of Zika virus infection are asymptomatic; however, when symptoms occur they are generally mild and flu-like. Laboratories in the United States are in need of diagnostic tools for use in the acute phase for rapid diagnosis of Zika virus infection. A public health emergency has been declared by the Secretary of Health and Human Services (HHS) on February 26, 2016, justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.