Intended use
The RealStar® Zika Virus RT-PCR Kit U.S.* is a real-time RT-PCR test intended for the in vitro qualitative detection of RNA from the Zika virus in serum, EDTA plasma or urine (collected alongside a patient-matched serum or EDTA plasma specimen):
- From individuals meeting U.S. Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or
- U.S. 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).