The Zika virus (ZIKV) is a mosquito-borne virus originally discovered in the Zika Forest area in Uganda in 1947. The World Health Organization (WHO) declared the Zika Virus a Public Health Emergency of International Concern on 1 February 2016. WHO declared the emergency as over in November 2016 because the organization views Zika as an ongoing threat. There is no vaccine for this viral disease.
The FDA issued Emergency Use Authorization (EUA) for several diagnostic tools for the Zika virus, including the Trioplex Real-Time RT-PCR (rRT-PCR) assay and the Zika MAC-ELISA, which are being distributed to qualified laboratories. A global leader in medical imaging, laboratory diagnostics and healthcare information technology, Siemens Healthineers recently introduced its CE-marked immunoassay – the Novagnost® Zika Virus IgM μ-capture Assay – for Zika virus detection.
Commercially available to laboratories outside of the U.S., the assay is capable of detecting the Zika virus during the acute phase of infection, approximately a few days after the onset of symptoms. This assay enables enhanced patient outcomes through differential diagnostics according to the WHO test algorithm. Along with its real-time molecular VERSANT® Zika RNA 1.0 Assay (kPCR), Siemens Healthineers now offers laboratories Zika assays both for immunoassay and molecular detection.
In a company press release, Franz Walt, President, Laboratory Diagnostics, Siemens Healthineers said, “As the Zika virus continues to rise as a global public health concern, there is an increased focus on detecting the Zika virus during the acute phase of infection. With the introduction of the Novagnost Zika Virus IgM µ-capture Assay, Siemens Healthineers completes laboratories’ virus testing menu by delivering assays for both immunoassay and molecular detection”.