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Business, STEM

FDA Approves Quick Test For Detection of Ebola Virus

Image of the Ebola Virus, Source: CDC

Image of the Ebola Virus, Source: CDC

The Ebola virus is still making news, however, today’s news is not all negative. Corgenix Medical Corporation, a Colorado firm that develops and manufactures test kits, announced earlier this month that their ReEBOv Antigen Rapid Test has received FDA approval. [Ref 1]

The rapid test can be used under elevated risk conditions to detect the Ebola Zaire virus in individuals that display symptoms or have visited areas with Ebola outbreaks. This is good news for our global community.

The test will be used in cases where time is of the essence. While molecular tests are more sensitive in detecting Ebola Zaire, the turn-around-time for testing and results can take days. By contrast, Corgenix’s rapid test can diagnose suspected cases in 15 to 25 minutes.

In an earlier post on this topic, Numbers: Ebola Virus Disease (EVD), the U.S. did not see its first diagnosed case of EVD until September 30, 2014. This came 10 days after Thomas Duncan flew from Liberia to Dallas, TX. He complained of not feeling well, made a visit to the hospital, was released and sent home. The delay in identifying the Ebola virus in this patient resulted in the exposure of family members and many others to this deadly virus. He later died of the disease.

Had a rapid test like ReEBOv been available for use six months ago, clinicians could have used it as a first line of defense in making a decision to release, retain or quarantine this patient, and thereby minimize the exposure described above. It is not difficult to see the relationship between business and STEM provided by the ReEBOv Antigen Rapid Test. The reduction from days to less than a half-hour for preliminary test results reinforces protection of public health and minimizes the number of persons that could be potentially exposed to the deadly virus.

The test can be performed in any clinical facility that is sufficiently equipped to administer it, the company said. It is not intended for use in general Ebola virus screenings, such as airport screening or contact tracing. Approval by the FDA follows the World Health Organization’s listing for procurement of the test, making it available worldwide.

Two days ago, media sources reported the arrival of an American healthcare worker that tested positive for the Ebola virus while working in Sierra Leone. The patient is being treated at the National Institutes of Health (NIH) in Bethesda, MD. This patient is the 11th person treated for this deadly virus in the U.S.

References

  1. News Release: Corgenix Receives FDA Authorization and WHO Listing for Emergency Use of Ebola Rapid Diagnostic Test,   February 26, 2015, http://www.corgenix.com/news-releases/corgenix-receives-fda-authorization-and-who-listing-for-emergency-use-of-ebola-rapid-diagnostic-test/
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About Vi Brown

Vi is principal and CEO of Prophecy Consulting Group, LLC, an Arizona firm that provides business and engineering services to private and public clients. Prior to establishing her consulting practice in 2001, Vi worked with Motorola, Maricopa County Government, Pacific Gas & Electric, CH2M Hill, and Procter & Gamble. As an adjunct faculty member, Vi teaches undergraduate calculus classes and graduate level environmental courses. She is also a professional speaker.

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