Siemens gets FDA emergency use authorisation for VERSANT Zika kPCR Kit

1 August 2016 (Last Updated August 1st, 2016 18:30)

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.

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.

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.