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Xpert® Ebola

Xpert® Ebola

Product catalog summary

Introduction
The document discusses the Xpert® Ebola diagnostic test, an in vitro diagnostic medical device designed for the accurate and reliable detection of the Ebola Zaire Virus. The need for such a test is underscored by the sporadic outbreaks of Ebola virus disease (EVD) in West Africa and its potential to spread globally, as seen in recent outbreaks.

The Need
EVD is a severe and highly contagious illness with a fatality rate that can reach up to 90%. Early supportive care can significantly improve survival rates. The global spread of EVD highlights the necessity for fast and accurate diagnostics.

The Solution
The Xpert® Ebola test offers unprecedented sensitivity and accuracy through a dual target design, similar to Cepheid’s Anthrax test. It features a sample reagent that reduces biohazard risks and provides on-demand results, empowering physicians to manage crises effectively. The self-contained cartridge system minimizes contamination risks.

Workflow
The test involves a simple three-step process: adding the sample to the reagent tube, incubating, and then inserting the sample into the cartridge for testing. The total hands-on time is less than one minute, with results available in 98 minutes.

Impact
The test's impact on biosafety is significant, as inactivated samples can be handled in BSL2 laboratories. The dual target assay design ensures high accuracy, and the virucidal efficacy of the sample reagent is demonstrated through internal data.

Specifications
The Xpert® Ebola test is a qualitative real-time reverse transcriptase PCR test. It is available in packages of 10 or 50 tests, with a sample collection device available separately.

Contact Information
Corporate and European headquarters contact details are provided for further inquiries.

References
The document cites several WHO publications and a poster session presented at the 7th International Symposium on Filoviruses.

Catalog excerpts

Xpert Ebola Accurate and reliable detection of Ebola Zaire Virus In Vitro Diagnostic Medical Device

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The goal of interrupting chains of Ebola virus transmission depends heavily on laboratory support. This support is needed to confirm or discard suspected cases, guide triage and clinical decisions, aid contact tracing, and facilitate the early detection of cases.” World Health Organization. As reported in Ebola situation assessment. 18 Nov 2014.1 Since the first discovery of Ebola virus in 1976, Ebola virus disease (EVD) has occurred sporadically throughout West Africa. Xpert Ebola delivers: EVD is a severe and highly contagious illness. The fatality rate can be as high as 90%. However, the survival...

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Xpert® Ebola will accelerate your laboratory's workflow with on-demand, random-access flexibility. In combination with other available Xpert® tests (including Flu/RSV XC, GBS, MRSA, C. difficile, CT/NG, and MTB/RIF), Cepheid's GeneXpert® System delivers proven productivity increases in overall laboratory service. Be Prepared • Fast turn-around time - results in 98 minutes • Ultrasensitive: can detect as few as 0.13 PFU/mL of Ebola Zaire Virus • Simple sample processing makes the test ideal for emergency use • Accepts whole blood (EDTA or finger-stick) or buccal swab specimens * IMPACT OF DUAL...

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3 EASY STEPS Total hands-on time: <1 Minute Add sample to the Sample Reagent Tube and incubate for 20 minutes at room temperature Pipette inactivated sample into cartridge 3 Insert cartridge and start test Xpert® Ebola is a qualitative real-time reverse transcriptase PCR test for automated detection of Ebola Zaire virus. CATALOG NUMBER Xpert Ebola (10 tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GXEBOLA-CE-10 Xpert Ebola (50 tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....

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