Siemens Healthcare Diagnostics has secured the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its real-time PCR Zika Virus assay, the VERSANT Zika RNA 1.0 Assay (kPCR) Kit.

The VERSANT Zika RNA 1.0 Assay (kPCR) Kit can facilitate an early detection of the Zika virus.

Siemens molecular diagnostics head and vice-president Fernando Beils said: “The FDA’s emergency use authorisation of the VERSANT Zika RNA 1.0 Assay (kPCR) Kit from Siemens can lead us one step closer to stopping the spread of the Zika virus.

"The VERSANT Zika RNA 1.0 Assay (kPCR) Kit can facilitate an early detection of the Zika virus."

“Being able to quickly diagnose patients will help physicians to more efficiently manage those affected.”

The molecular test can be performed on specimens like plasma, serum, and urine derived from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and / or CDC Zika virus epidemiological criteria.

The epidemiological criteria is considered on the basis of a person’s history of travelling to places which have experienced a Zika virus outbreak.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The test kit has been designed to operate on the Siemens VERSANT kPCR Sample Prep automated platform, along with several commercially available thermal cyclers.

Zika virus is carried by Aedes mosquitoes which cause symptoms such as mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise or headache which last for several days to a week.

Infection of a pregnant woman can cause the fetus to develop microcephaly, which is an abnormal smallness of the head causing incomplete brain development.