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Home / Products / RealStar / RealStar® Ebolavirus RT-PCR Kit 1.0*
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RealStar® Ebolavirus RT-PCR Kit 1.0*

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.

 

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

 

_____________________________________________________________________________________________

 

Related product – The RealStar® Ebolavirus Quantification Panel 1.0

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.

 

For use with

QIAamp® Viral RNA Mini Kit

Regulatory status
EUA
RealStar® Ebolavirus RT-PCR Kit 1.0*
Order No
581023
Rxns
96
Transportation
Dry ice
RealStar® Ebolavirus Quantification Panel 1.0
Order No
5810QP
Components
10 x 140 μl
Transportation
Dry ice

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

Manuals RealStar® Ebolavirus RT-PCR Kit 1.0*
Download
Associated documents RealStar® Ebolavirus RT-PCR Kit 1.0*
Download
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Manuals RealStar® Ebolavirus RT-PCR Kit 1.0*
Language
RealStar® Ebola RT-PCR Kit 1.0* - EN
Language: English
Date: 2020-05
Panel: Fever, tropical, emerging (FTE) infections
Regulatory status: EUA
Associated documents RealStar® Ebolavirus RT-PCR Kit 1.0*
Language
Type of document
RealStar® Ebola RT-PCR Kit 1.0* - EN - 1
Language: English
Date: 2014-11-26
Panel: Fever, tropical, emerging (FTE) infections
Regulatory status: EUA
RealStar® Ebola RT-PCR Kit 1.0* - EN - 2
Language: English
Date: 2016-02-12
Panel: Fever, tropical, emerging (FTE) infections
Regulatory status: EUA
RealStar® Ebola RT-PCR Kit 1.0* - EN - 3
Language: English
Date: 2016-02-12
Panel: Fever, tropical, emerging (FTE) infections
Regulatory status: EUA
RealStar® Ebola RT-PCR Kit 1.0* - EN - 4
Language: English
Date: 2015-02
Panel: Fever, tropical, emerging (FTE) infections
Regulatory status: EUA
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