Luminex Corp, Austin, Tex, has received FDA emergency use authorization (EUA) for a multiplex nucleic acid test designed to detect Zika virus RNA in potentially infected patients using blood serum, plasma, or urine specimens.
Designed by Luminex partner GenArraytion Inc, Rockville, Md, the xMap MultiFlex Zika RNA assay detects Zika viral RNA in serum, plasma, or urine collected alongside a patient-matched serum or plasma specimen. The Zika virus can be detected in blood and urine, and in July 2016 the US Centers for Disease Control and Prevention updated its guidance to clinicians to recommend serum and urine testing for specimens collected less than 14 days after symptom onset.
The xMap MultiFlex Zika RNA assay from GenArraytion.
The assay is available for purchase by laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests. The multitarget assay uses the Luminex 100/200 or Magpix instrument, or other authorized instruments, to simultaneously test for six genetic targets of the Zika virus.
Luminex’s xMap technology combines advanced fluidics, optics, and digital signal processing with proprietary microsphere technology to deliver multiplexed assay capabilities. Featuring a flexible, open-architecture design, the technology can be configured to perform a wide variety of protein or nucleic acid assays, and enables multiplexing of biological tests. Using the technology, systems can perform discrete assays on the surface of color-coded beads known as microspheres, which are then read in a compact analyzer. Using multiple lasers or LEDs and high-speed digital-signal processors, the analyzer reads multiplex assay results by reporting the reactions occurring on each individual microsphere.
Homi Shamir, Luminex.
“We are pleased that our innovative xMap MultiFlex Zika RNA assay has been granted emergency use authorization by FDA,” says Nachum “Homi” Shamir, president and CEO of Luminex. “Together with our partner, GenArraytion Inc, we have responded to this crisis and are currently in discussions with key public health, reference, and hospital laboratories. As a leader in multiplex diagnostic testing for infectious diseases, we are proud to help enable healthcare providers to rapidly detect Zika virus with this assay today, and we intend to expand our coverage to include a broader array of mosquito-borne disease agents in the future to aid in treatment decisions for potentially afflicted patients.”
“Luminex molecular assays simultaneously detect multiple Zika targets and can detect the disease-causing viral pathogen earlier than serology assays,” says R. Paul Schaudies, CEO of GenArraytion Inc. “We are excited to use the highly flexible Luminex platforms for the development of key emerging infectious disease markers.”
The xMap MultiFlex Zika RNA assay has not been FDA cleared or approved, and is authorized for use only for the duration of the declaration justifying such emergency use. For more information, visit Luminex or GenArraytion.
