New Immunoassay Developed for Zika Virus Detection

The new assay can improve patient care by enabling differential diagnostics according to the World Health Organization (WHO) test algorithm. It is capable of detecting Zika virus during the acute phase of infection, approximately a few days after the onset of symptoms.

The CE-marked Novagnost Zika virus IgM µ-capture assay, developed by Siemens Healthineers of Siemens Healthcare, is now commercially available in many countries (currently not available in the US). The assay is user-friendly, utilizing the same dilution and reagents as other Novagnost assays. It is validated for use on plasma and serum, and can be performed on the BEP III and BEP 2000 Advance Systems (currently not available in the US).

Together with the recently announced real-time molecular VERSANT Zika RNA 1.0 Assay (kPCR), Siemens Healthineers thus now offers Zika assays both for immunoassay and molecular detection. The VERSANT Zika assay is currently intended for research use only (RUO) in regions outside of the US. In July 2016, it received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA), allowing 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.

"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."