Description
Intended use
The RealStar® Ebolavirus RT-PCR Kit 1.0* is for the presumptive detection of RNA from Ebolavirus (including Zaire ebolavirus detected in the West Africa outbreak in 2014) on specified instruments in EDTA plasma specimens from individuals with signs and symptoms of Ebolavirus infection in conjunction with epidemiological risk factors.
Specifications
Sample type
Human EDTA plasma
For use with
ABI Prism® 7500 SDS (Applied Biosystems)
ABI Prism® 7500 Fast SDS (Applied Biosystems)
LightCycler® 480 Instrument II (Roche)
CFX96™ 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 Ebolavirus (such as Zaire ebolavirus (including Zaire ebolavirus strain detected in the West Africa outbreak in 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus and Reston ebolavirus) and not for any other viruses or pathogens; 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 Zaire ebolavirus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- The RealStar® Ebolavirus RT-PCR Kit 1.0* is ready-to-use and compatible with various real-time PCR platforms.
