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Diagnostic Validation of the RealStar® Zika Virus Reverse Transcription Polymerase Chain Reaction Kit for Detection of Zika Virus RNA in Urine and Serum Specimens

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  • 1 altona Diagnostics GmbH, Hamburg, Germany;
  • | 2 Laboratoire de Virologie, CNR des Arbovirus, Institut Pasteur de la Guyane, Cayenne, French Guiana

With the Zika virus outbreak in South America starting in 2015 and its potential to cause malformation of the fetus in infected women, the need for diagnostic methods became obvious. Until now, only limited data are available on the diagnostic performance of commercial kits. Here, we present data comparing the RealStar® Zika Virus RT-PCR Kit 1.0 for detection of Zika virus from 208 serum and urine samples collected in French Guiana with a reference method. Of these, 114 samples tested positive with the RealStar® Kit and 111 with the reference method.

Author Notes

Address for correspondence to Stephan Ölschläger, altona Diagnostics GmbH, Mörkenstrasse 12, 22767 Hamburg, Germany. E-mail: stephan.oelschlaeger@gmail.com

Authors’ addresses: Stephan Ölschläger and Mareen Zaruba, altona Diagnostics GmbH, Research and Development, Hamburg, Germany, E-mails: stephan.oelschlaeger@gmail.com and mareen.zaruba@altona-diagnostics.com. Antoine Enfissi, Mirdad Kazanji, and Dominique Rousset, Laboratoire de virology Institut Pasteur de la Guyane, Laboratoire de virology, Cayenne, French Guiana, E-mails: aenfissi@pasteuer-cayenne.fr, mkazanji@pasteur-cayenne.fr, and drousset@pasteur-cayenne.fr.