Photo by William Weinert
Blood samples
The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the CII-ArboViroPlex rRT-PCR Test.
It is 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.
The EUA does not mean the CII-ArboViroPlex rRT-PCR Test is FDA cleared or approved.
An EUA allows for the use of unapproved medical products in an emergency. The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The EUA for the CII-ArboViroPlex rRT-PCR Test means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.
About the 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 4 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 2 hours and ZIKV in urine (collected alongside a patient-matched serum specimen).
The CII-ArboViroPlex rRT-PCR Test was developed by scientists at the Center for Infection and Immunity (CII) at Columbia University’s Mailman School of Public Health in New York, New York. The manufacture of the test will be overseen by CII.
The CII-ArboViroPlex rRT-PCR Test is authorized to be used by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-US laboratories.
The CII-ArboViroPlex rRT-PCR Test 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).
“The ArboViroPlex Test provides an easy and efficient means to simultaneously detect Zika and 3 other mosquito-borne viral infections that may present with similar clinical features,” said Nischay Mishra, of CII.
“The FDA decision to issue the EUA gives clinicians and researchers a powerful tool to diagnose and prevent the spread of Zika,” added W. Ian Lipkin, director of CII.
More information on the CII-ArboViroPlex rRT-PCR Test Virus Kit and other Zika tests granted EUAs can be found on the FDA’s EUA page.
