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Press archive

2021-04-01

 

Hamburg, April 1st, 2021 altona Diagnostics GmbH, today announced the launch of the AltoStar® HIV RT-PCR Kit 1.5, an in vitro diagnostic test, based on real-time RT-PCR technology, for the detection and quantification of human immunodeficiency virus type 1 (HIV-1) specific RNA (groups M, N and O) in human EDTA plasma.

 

Designed as a dual target assay, the AltoStar® HIV RT-PCR Kit 1.5 allows amplification of separate regions of the HIV-1 genome to monitor HIV infected patients. The ready-to-use kit consists of master reagents, a No Template Control and Quantification Standards calibrated against the 4th WHO International Standard for HIV-1 RNA.

 

2020-04-30

 

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

 

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

 

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

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.