RealStar® Zika Virus RT-PCR Kit 1.0 receives ANVISA approval
São Paulo, Brazil, 25th of June 2018.
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 such as blood plasma, serum and urine. The RealStar® Zika Virus RT-PCR Kit 1.0 (Cat. No. 591013) is part of altona´s broad portfolio of tests for tropical and emerging diseases based on real-time PCR. The test previously got WHO´s emergency use and assessment listing (EUAL) as well as FDA emergency use authorization (EUA) after it was CE-IVD marked in 2016. Validation with clinical human sample material was performed at the Virology Lab and National Reference Centre for Arboviruses at Institute Pasteur in Cayenne, French Guiana. Following altona´s open platform strategy the PCR kit can be used with a variety of real-time PCR cyclers, most commonly found in diagnostic laboratories.
“Since one of the focus areas of altona has been and continues to be tropical and emerging diseases, and Latin America, especially Brazil, has shown a history of these diseases as well as major outbreaks of already known human pathogens, it has been a natural development for altona to get closer to its Latin American collaborators and customers by opening subsidiaries, both in Brazil and in Argentina,” explained Hans Kuhn, heading the operations at both sites. altona opened its operation in São Paulo in 2017 in order to serve the Brazilian market with its diagnostic tests as well as for technical support during implementation and routine use.
altona Diagnostics Brasil LTDA
Rua São Paulino 221 - Vila Mariana
São Paulo, CEP 04019-040
Tel/Fax: +55 (11) 5083-1390