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.
December 1 is World AIDS Day. AIDS is caused by the infection with the human immunodeficiency virus (HIV). Today, viral replication can be suppressed by antiretroviral therapy (ART). With the AltoStar® HIV RT-PCR Kit 1.5, altona provides an CE-marked RT-PCR test to detect and quantify the human immunodeficiency virus type 1 (HIV-1) specific RNA (groups M, N and O) in human EDTA plasma.