altona Diagnostics’ RealStar® Zika Virus RT-PCR Kit 1.0 received Emergency Use Authorization (EUA) from the Korea Centers for Disease Control & Prevention (KCDC).
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.
20.05.2016 - 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.