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Press archive

2020-04-30

altona Diagnostics launches CE-IVD certified RT-PCR test for SARS-CoV-2 detection

 

Hamburg, April 30th 2020, altona Diagnostics GmbH announced today the launch of the CE-IVD marked RealStar® SARS-CoV-2 RT-PCR Kit 1.0 an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of lineage B-beta coronavirus (lineage B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA. It is intended to be used as an aid for diagnosis in individuals with signs and symptoms of coronavirus disease 2019 (COVID-19) in conjunction with clinical and epidemiological risk factors.

 

Furthermore, on April 23, 2020 altona Diagnostics also received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the RealStar® SARS-CoV-2 RT-PCR Kit U.S. whose components are chemically identical with the ones included in the CE-IVD marked RealStar® SARS-CoV-2 RT-PCR Kit 1.0. The RealStar® SARS-CoV-2 RT-PCR Kit U.S. intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory samples from individuals who are suspected of COVID-19 by their healthcare provider.

2020-02-20

Assay development for SARS-CoV-2 testing successfully completed

 

Hamburg, February 20, 2020, altona Diagnostics GmbH, today announced the launch of the RealStar® SARS-CoV-2 RT-PCR Kit 1.0. The assay is based on real-time RT-PCR technology, for the detection of SARS-CoV-2 (previously 2019-nCoV) which is the causative agent of coronavirus disease 2019 (COVID-19).

2019-02-07

altona Diagnostics receives CE-IVD mark for HCV RT-PCR test

 

Hamburg, February 07, 2019 altona Diagnostics GmbH, today announced the launch of the AltoStar® HCV RT-PCR Kit 1.5, an in vitro diagnostic test, based on real-time RT-PCR technology, for the detection and quantification of hepatitis C virus (HCV) specific RNA (genotypes 1 to 6). Read more

2018-06-25

RealStar® Zika Virus RT-PCR Kit 1.0 receives ANVISA approval

altona Diagnostics Brasil LTDA, São Paulo, the Brazilian subsidiary of the German infectious disease specialist altona Diagnostics GmbH (altona), Hamburg, got registration approval of ANVISA for its real-time PCR kit to detect RNA of Zika virus in human sample material.

2018-04-19

altona Diagnostics launches CE-IVD marked AltoStar® Molecular Diagnostic Workflow

altona Diagnostics celebrates the launch of the AltoStar® Molecular Diagnostic Workflow.The recently developed CE-IVD marked system will be shown at the ECCMID 2018 which will take place in Madrid, Spain, from 21 - 24 April 2018.