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News Archive

2016-08-19

WHO has accepted the first Zika virus Diagnostic test eligible for procurement agencies and Member States. The RealStar® Zika Virus RT-PCR Kit 1.0 manufactured by altona Diagnostics was assessed under the Emergency Use Assessment and Listing Procedure (EUAL) opened to candidate in vitro diagnostics (IVDs) intended for Zika virus diagnosis in February 2016.

2016-08-05

altona Diagnostics’ RealStar® Zika Virus RT-PCR Kit 1.0 received Emergency Use Authorization (EUA) from the Korea Centers for Disease Control & Prevention (KCDC).

2016-05-13

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 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

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.