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 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).

*only available in USA - For use under the Emergency Use Authorization (EUA) only.

The RealStar^® Zika Virus RT-PCR Kit U.S.* can also be used with other authorized specimen types and is authorized for a workflow consisting of nucleic acid extraction using the QIAamp^® Viral RNA Mini Kit (QIAGEN), the MagNA Pure 96 Instrument (Roche) in combination with the MagNA Pure 96 DNA and Viral NA Small Volume Kit (Roche) and the NucliSENS^® easyMAG^® Instrument (bioMérieux) in combination with the NucliSENS^® easyMAG^® reagents and disposables (bioMérieux), followed by the amplification and detection of Zika virus specific RNA using the RealStar^® Zika Virus RT-PCR Kit U.S.*.

The test performance for the use with serum and urine samples was validated by the Institute Pasteur de la Guyane, Cayenne, French Guiana.

Please remark:

This test has not been FDA-cleared or approved
This test has been authorized by FDA under an EUA for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories
This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection and not for any other viruses or pathogenes
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

Any adverse events should be sent to the following e-mail address: support@altona-diagnostics.com