14 April is World Chagas Disease Day, one of the WHO global health days. Worldwide about 6–7 million people are currently infected with the parasite T. cruzi and most of them are living in Central and South America. Testing is crucial to fight Chagas disease. With the RealStar® Chagas PCR Kit 1.0 altona Diagnostics provides an in vitro diagnostic test for the qualitative detection of Trypanosoma cruzi specific DNA.
The CE-IVD version of the FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 from altona Diagnostics is available now. It’s an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza virus specific RNA in human respiratory swab specimens. The FlexStar® (RT-)PCR Amplification Mix 1.5 is also CE marked now.
In recent years altona Diagnostics has made preparations for the original date of application (May 26, 2022) of the European Regulation 2017/746 on in vitro diagnostic medical devices(IVDR). In October 2021, extended transition periods were proposed by the European Commission. Nevertheless, we go forward with our IVDR projects regarding our AltoStar® kits. On Dec 20, 2021, eighteen AltoStar® (RT-)PCR kits and sample preparation reagents are relaunched.
The FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 (RUO) is out now. It’s the first product of the gastrointestinal panel of the FlexStar® product line. A CE-IVD version will be available soon. The FlexStar® HAdV & HAstV & SaV RT-PCR Detection Mix 1.5 will be the next product available in the gastrointestinal panel.