RealStar Ebolavirus RT-PCR Kit 1.0

The RealStar Ebolavirus RT-PCR Kit 1.0 (altona Diagnostics GmbH) has not been FDA cleared or approved.

The RealStar Ebolavirus RT-PCR Kit 1.0 is designed to detect RNA from Ebolaviruses. The test is based on real-time reverse transcription-polymerase chain reaction (RT-PCR) technology, utilizing reverse transcription to convert RNA into complementary DNA (cDNA), PCR for the amplification of specific target sequences, and target-specific probes for detection of the amplified DNA. Master A and Master B reagents contain all components (buffer, enzymes, primers, and probes) to perform reverse transcription, PCR-mediated amplification, and target detection (Ebolavirus-specific RNA and Internal Control) in one reaction setup. The probes are labeled with fluorescent reporter and quencher dyes. The Ebolavirus L gene, which codes for the viral polymerase and contains highly conserved sequence elements, serves as the target sequence for the test. Prepared samples are analyzed with a real-time PCR instrument.

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. The RealStar Ebolavirus RT-PCR Kit 1.0 is configured for use with only the ABI Prism 7500 SDS instrument, the ABI Prism 7500 Fast SDS instrument, the LightCycler 480 instrument II, and the CFX96 system/Dx real-time system.

Probes specific for Ebolavirus RNA are labeled with the fluorophore FAM. The probe specific for the target of the Internal Control is labeled with the fluorophore JOE. Using probes linked to distinguishable dyes enables the detection of Ebolavirus-specific RNA as well as the Internal Control in the corresponding detector channels of the specified real-time PCR instrument.

Note

The RealStar Ebolavirus RT-PCR Kit 1.0 is authorized for the presumptive detection of RNA from Ebolaviruses in plasma from individuals with signs and symptoms of Ebolavirus infection in conjunction with clinical and epidemiological risk factors.

This assay has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories.
This assay has been authorized only for the detection — not differentiation — of RNA from Ebolaviruses (such as Zaire ebolavirus, [including the Zaire ebolavirus strain detected in the West Africa outbreak 2014], Sudan ebolavirus, Taï Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus) and not for any other viruses or pathogens.

This assay 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 Ebola Zaire 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.

Additional terms and conditions for the usage of the RealStar Ebolavirus RT-PCR Kit 1.0 can be found on the FDA website.