Technology Bundle ID: TAB-3161

CDC Trioplex – A Real-Time RT-PCR Assay for the Diagnosis of Zika, and Differentiation from Dengue & Chikungunya Virus Infections

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Licensing Contact:
Primary Inventors: 
Jorge Munoz-Jordan (CDC)
Co-Inventors: 
Gilberto Santiago (CDC), Robert Lanciotti (CDC)
Institute or Center: 
CDC

As of March 2017, 64 countries and territories had travel notices for active Zika virus transmissions. CDC developed the Trioplex rRT-PCR test to detect evidence of Zika virus infection and aid in differentiating this infection from dengue and chikungunya virus infections, all of which are spread by the same types of Aedes species mosquitoes and cause similar illness. The Trioplex Real-time RT-PCR assay is for qualitative detection and differentiation of RNA from dengue, chikungunya and Zika viruses in serum, whole blood, urine, amniotic fluid and cerebral spinal fluid, and for the qualitative detection of Zika virus RNA in urine and amniotic fluid. This assay protocol is designed to facilitate simultaneous testing for the three viruses using a single sample in the same plate well (multiplex). A singleplex reaction (measuring one analyte at a time) is also an option for chikungunya and dengue testing in serum, whole blood, and cerebrospinal fluid (other specimen types if one primer/probe set per well is preferred). The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Trioplex assay on March 17, 2016.

Applications:
  • Assay is currently in use by public health labs to support the 2016 Zika outbreak; licensee(s) can potentially take over providing these assays
  • Diagnostic assay for the detection and differentiation of Zika, chikungunya and dengue viruses
  • Quality Assurance/Quality Control (QA/QC) testing
Advantages:
  • Currently, there is no multiplex PCR assay on the market that can detect and differentiate Zika, dengue and chikungunya in one test
  • There is no FDA-approved chikungunya test on the market and current Zika and dengue tests must be run separately
  • This was the second diagnostic assay that tests for Zika to receive FDA's EUA (CDC has the first two tests, Trioplex and the Zika MAC-ELISA assay, to receive FDA's EUA for diagnosing Zika)

Patents

PCT Application PCT/US2017/023021
Filed on 2017-03-17

Publications

Santiago G.A., et al. Performance of the Trioplex Real-Time RT-PCR Assay for Detection of Zika, Dengue, and Chikungunya Viruses, Nature Communications 2018 Apr 11;9(1):1391.
DOI:10.1038/s41467-018-03772-1

Updated

Sep 6, 2017

Data Source: 
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