Siemens Healthineers Announces New Immunoassay for Detection of Zika

Siemens Healthineers announced its CE-marked immunoassay—the Novagnost Zika Virus IgM µ-capture Assay¹—is now commercially available to laboratories outside of the U.S.
 
The Novagnost Zika Virus IgM µ-capture Assayenables enhanced patient outcomes through differential diagnostics according to the WHO test algorithm. The assay is capable of detecting the Zika virus during the acute phase of infection, approximately a few days after the onset of symptoms. Together with the recently announced real-time molecular VERSANT Zika RNA 1.0 Assay (kPCR)², Siemens Healthineers is now offering laboratories Zika assays both for immunoassay and molecular detection.
 
The Novagnost Zika Virus IgM µ-capture Assay is user-friendly, utilizing the same dilution and reagents as other Novagnost assays. The assay can be performed on the BEP III¹ and BEP 2000 Advance Systems¹ and is validated for use on plasma and serum.
 
“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,” said Franz Walt, president, Laboratory Diagnostics, Siemens Healthineers. “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.”  
 
Siemens Healthineers aims to enable healthcare providers around the world to meet their current challenges and to excel in their respective environments. Siemens Healthineers is setting new trends in healthcare together with its customers—working under the motto “Engineering Success. Pioneering Healthcare. Together.”
 
¹ Not available for sale in the U.S. Product availability may vary by country.
² The VERSANT Zika RNA 1.0 Assay (kPCR) is intended for research use only (RUO) in regions outside of the U.S. In July 2016, the VERSANT Zika RNA 1.0 Assay received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). EUA allows for unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threats when there are no adequate, approved, and available alternatives. For more information, visit: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/ucm182568.htm.