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02/01/2016

altona Diagnostics launches worldwide first commercially available CE-IVD real-time PCR test for detection of Zika Virus

The RealStar® Zika Virus RT-PCR Kit 1.0 is an in vitro diagnostic test based on real-time reverse transcriptase/polymerase chain reaction (RT-PCR) technology for the identification of Zika virus. RealStar® Kits are CE-IVD marked test systems for the detection and quantifica-tion of viruses, bacteria, and parasites. The assays meet all applicable requirements of the IVD Directive 98/79/EC. With the development of the RealStar® Zika Virus RT-PCR Kit 1.0 altona Diagnostics enlarges its panel of CE-IVD marked ready-to-use kits for the reliable de-tection of tropical pathogens.

Zika virus is mainly transmitted by mosquitoes of the genus Aedes. In 2007 the virus caused a large outbreak in Micronesia and other islands in the Pacific Ocean. Since 2014 the virus is also endemic to South America, namely Brazil. Fever, rash and arthralgia, which usually are mild and self-limiting, are common symptoms of a Zika virus infection. Since October 2015, the Brazilian Health Authorities reported a clear increase of babies and fetuses with micro-cephaly in regions with high numbers of Zika virus infections.

In cases of suspected Zika virus infection, Dengue and Chikungunya virus infections have to be ruled out as these viruses are endemic to the same geographical regions and cause simi-lar symptoms. A definite identification of the etiological agent causing the aforementioned symptoms is only possible with laboratory testing. altona Diagnostics distributes CE-IVD marked real-time PCR test kits for Zika virus as well as Dengue and Chikungunya (RealStar® Zika Virus RT-PCR Kit 1.0, RealStar® Dengue RT-PCR Kit 2.0 and RealStar® Chikungunya RT-PCR Kit 2.0).

altona Diagnostics, founded in 2007 and based in Hamburg, Germany, is focused on devel-oping and manufacturing molecular diagnostic test systems for the detection and quantifica-tion of pathogens related to human infectious diseases. altona Diagnostics is ISO 13485 cer-tified and manufactures under cGMP guidelines. Among other activities, altona Diagnostics was one of the first companies to make reliable molecular diagnostic kits commercially avail-able during outbreak situations for SARS, avian Flu, swine Flu, EHEC, MERS, and Ebo-lavirus.

 

Source: Press release altona Diagnostics, January 27th, 2016

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