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News Archive

2016-05-13

altona Diagnostics Receives Emergency Use Authorization of RealStar® Zika Virus RT-PCR Kit U.S.

The RealStar® Zika Virus RT-PCR Kit U.S. is a real-time RT-PCR test  intended for the qualitative detection of RNA from the Zika virus in serum or urine (collected alongside a patient-matched serum specimen) from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

2016-01-27

altona Diagnostics launches test for detection of Zika virus

altona Diagnostics developed the RealStar® Zika Virus RT-PCR Kit 1.0 for the qualitative detection of Zika virus specific RNA. The in vitro diagnostic test is based on real-time reverse transcriptase/polymerase chain reaction (RT-PCR) technology and contains an Internal Control for reliable diagnostics.

2015-07-22

altona Diagnostics Receives Emergency Use Authorization of RealStar® MERS CoV RT-PCR Kit U.S.

The RealStar® MERS-CoV RT-PCR Kit U.S. is a real-time reverse transcriptase polymerase chain reaction (rRT-PCR) test for the in vitro qualitative detection of RNA from MERS-CoV in lower respiratory specimens (tracheal aspirate/tracheal secretions) from individuals with signs and symptoms of infection with MERS-CoV in conjunction with epidemiological risk factors. The RealStar® MERS-CoV RT-PCR Kit U.S. consists of two independent assays, one targeting a region upstream of the E gene (upE) and the other targeting open reading frame 1a (orf1a) of the MERS-CoV genome.  Both assays include a heterologous amplification system (Internal Control) to identify possible RT-PCR inhibition and to confirm the integrity of the reagents of the kit.

2015-07-10

altona Diagnostics GmbH - Letter to the editor/The Lancet

We would like to comment on the article by Broadhurst et al. The authors compared the ReEBOV Antigen Rapid Test Kit (Corgenix Inc) with the RealStar® Filovirus Screen RT-PCR Kit 1.0 (altona Diagnostics GmbH) and an in-house developed real-time RT-PCR method referred to as Trombley-assay.

2015-02-25

Detection of drifted Influenza A (H3N2) viruses

The RealStar® Influenza S&T RT-PCR Kit 3.0 and the RealStar® Influenza RT-PCR Kit 1.0 facilitate the detection of the drifted influenza A (H3N2) viruses circulating as dominant subtype in the 2014/15 influenza season in Europe: