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).
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.
The RealStar® Zika Virus RT-PCR Kit U.S.* is ready-to-use and compatible with various real-time PCR platforms.
- 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; and
- 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 Email adress: firstname.lastname@example.org
|Prod. No||Product||For use with|
|591023||RealStar® Zika Virus RT-PCR
|ABI Prism® 7500 SDS and 7500 Fast SDS, CFX96™ Real-Time PCR Detection System and CFX96™ Deep Well Real-Time PCR Detection System, LightCycler® 480 Instrument II, Rotor-Gene® 6000, Rotor-Gene® Q 5/6 plex Platform|
Please find here further important documents:
Letter of Authorization (Date of EUA issuance 2016-05-13) (PDF)
Letter Granting EUA Amendment (2016-31-10) (PDF)
Letter Granting EUA Amendment (2017-03-06) (PDF)
Fact Sheet for Health Care Providers (update 2017-03-06) (PDF)
Fact Sheet for Patients (update 2017-03-06) (PDF)
*only available in USA