Description
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).
Specifications
Sample types
Human serum
Human EDTA plasma
Human urine
For use with
- ABI Prism® 7500 SDS (Applied Biosystems)
- ABI Prism® 7500 Fast SDS (Applied Biosystems)
- LightCycler® 480 Instrument II (Roche)
- Rotor-Gene® 6000 (Corbett Research)
- Rotor-Gene® Q 5/6 plex/MDx Platform (QIAGEN)
- CFX96™ Real-Time PCR Detection System (Bio-Rad)
- CFX96™ Deep Well Real-Time PCR Detection System (Bio-Rad)
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
