RealStar® Ebolavirus RT-PCR Kit 1.0*
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.
*Only available in USA. For use under the Emergency Use Authorization (EUA) only.
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.
RealStar® Ebolavirus RT-PCR Kit 1.0*
| Order No. | 581023 |
| Rxns | 96 |
| Sample types | Human EDTA plasma |
| Transportation | Dry ice |
| For use with | ABI Prism® 7500 SDS and 7500 Fast SDS LightCycler® 480 Instrument II CFX96™ Real-Time PCR Detection System |
Related Product:
The RealStar® Ebolavirus Quantification Panel 1.0 is a five member verification and validation panel representing three different concentrations (low, middle and high) of an in-vitro transcript (IVT) comprising the target sequence of the RealStar® Ebolavirus RT-PCR Kit 1.0. It can be used for the verfication and validation of the RealStar® Ebolavirus RT-PCR KIt 1.0.
The RealStar® Ebolavirus Quantification Panel 1.0 is for research use only and not for use in diagnostic procedures.
RealStar® Ebolavirus Quantification Panel 1.0
| Order No. | 5810QP |
| Components | 10 x 140 μl |
| Transportation | Dry ice |
| For use with | QIAamp® Viral RNA Mini Kit |
RealStar® Ebolavirus RT-PCR Kit 1.0*
| Release date: | 05/2020 |
RealStar® Ebolavirus RT-PCR Kit 1.0*
| Release date: | 26.11.2014 |
| Release date: | 12.02.2016 |
| Release date: | 12.02.2016 |
| Release date: | 02/2015 |