2nd February 2016 Content supplied by: altona Diagnostics GmbH
RealStar® Zika Virus RT-PCR Test is CE-IVD Marked
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 quantification 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 detection 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 microcephaly 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 similar 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).
The assay includes a heterologous amplification system (Internal Control) to identify possible RT-PCR inhibition and to confirm the integrity of the reagents of the kit. The test is based on real-time RT-PCR technology, utilizing a reverse-transcriptase reaction to convert RNA into complementary DNA (cDNA), PCR for the amplification of specific target sequences and target specific probes for the detection of the amplified DNA.
The probes are labelled with fluorescent reporter and quencher dyes. Probes specific for Zika virus RNA are labelled with the fluorophore FAM. The probe specific for the Internal Control is labelled with the fluorophore JOE. Using probes linked to distinguishable dyes enables the parallel detection of Zika virus specific RNA and the Internal Control in corresponding detector channels of the real-time PCR instrument. The test consists of three processes in a single tube assay:
- Reverse transcription of target RNA to cDNA
- PCR amplification of target cDNA and Internal Control
- Simultaneous detection of PCR amplicons by fluorescent dye labelled probes
Kit is now CE/IVD Marked.
Products not licensed with Health Canada and not FDA cleared or approved. Not available in all countries.
Date Published: 2nd February 2016
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