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Despite Regulatory Nod, Cheap Ebola Test Still Undeployed

According to an article in Nature, the researchers who developed an inexpensive, reliable field test for the Ebola virus are frustrated by the delay they've seen in actually having that test deployed. Known as the Corgenix test after the company which developed it, this diagnostic tool "could not replace lab confirmation, but it would allow workers to identify infected people and isolate them faster, greatly reducing the spread of disease," according to infectious-diseases physician Nahid Bhadelia. However, though it's been approved both by the US FDA (for emergency use) and the World Health Organization, its practical use has been hampered by country-level regulations. Just why is unclear; the test seems to be at least as effective as other typical tests, and in some ways better. One concern was that the test might fail to detect the virus in some cases of Ebola. But the independent field-validation1 (in Sierra Leone) shows that the kit was as sensitive at catching cases as the gold-standard comparison — a real-time polymerase chain reaction (RT-PCR) test that amplifies and detects genetic sequences that are specific to Ebola in blood and other bodily fluids.

25 comments

  1. Asian Dad by Anonymous Coward · · Score: 0

    EPLOY?
      Y U NO APLOY?

  2. stil? by turkeydance · · Score: 1

    hat's a sham.

  3. "...country-level regulations..." by magusxxx · · Score: 1

    Translation: Another drug company paid the government to use the country as lab rats.

    --
    Care killed the cat, but satisfaction brought it back.
    1. Re:"...country-level regulations..." by Anonymous Coward · · Score: 0

      Actually the reverse: The argument is that because the FDA says it's OK to use, everyone else should follow suit right away, or be labeled obstructionist.

      As much as *cough* some people *cough* like to think, actually blindly unthinkingly assume, otherwise, the USoA does not actually rule the world.

    2. Re:"...country-level regulations..." by Anonymous Coward · · Score: 0

      Or that the right government officials didn't get their pockets lined with international aid money. Constituency dying? There are no problems which couldn't be solved with a private militia during the next elections.

  4. Operating in Africa by rmdingler · · Score: 3, Interesting
    Overcoming tribal belief sets, sometimes even nationwide backwater thinking, is one of the key obstacles to stemming the flow of disease on the African continent.

    There is an inherent mistrust of outsiders that has been compounded by centuries of bad behavior by folks who look just like the people who are just here to help you.

    I suspect many tribal people would rather not be diagnosed at all.

    --
    Happiness in intelligent people is the rarest thing I know.

    Ernest Hemingway

    1. Re:Operating in Africa by sribe · · Score: 3, Insightful

      I suspect many tribal people would rather not be diagnosed at all.

      Exactly. They have not grown up being educated as the causes of disease and its spread. During the outbreak, people were hiding sick relatives from aid workers because they observed that once your name was put on the list, you got taken away and died. Cause and effect in their minds, because they lack the knowledge to understand the real cause, and the likely outcomes of different actions. This is not a problem that can be solved overall in the midst of an epidemic--it's something that requires a generation or two of effective universal public education, which is a big project.

    2. Re:Operating in Africa by PopeRatzo · · Score: 1

      Overcoming tribal belief sets, sometimes even nationwide backwater thinking, is one of the key obstacles to stemming the flow of disease on the African continent.

      Tribal belief sets and backwater thinking is a problem in a lot of highly developed parts of the world too. (I'm looking at you, Southern USA)

      --
      You are welcome on my lawn.
    3. Re:Operating in Africa by Immerman · · Score: 3, Insightful

      Probably also a generation or two of "we're here to help" medical programs not being hideously abused, as was done in various population-control endeavours and other programs. Involuntary sterilization under the guise of vaccinations? Really? That's the sort of horror story that can take generations to fade, and it seems like every time we start building back some trust among the population, someone decides to abuse it yet again.

      --
      --- Most topics have many sides worth arguing, allow me to take one opposite you.
    4. Re:Operating in Africa by Anonymous Coward · · Score: 1

      I suspect many tribal people would rather not be diagnosed at all.

      I am genuinly surprised how people feel this is an African or tribal thing. Imagine yourself at home with your child being sick. Would you let men in biohazard suits take your loved one away into an environment where everyone else is definitely infected with ebola and where they will almost certainly die alone and terrified, far beyond your reach?

      I think most western people would also irrationally hope that their child is not infected with ebola, or might rather risk getting infected themselves and at least be there in their final moments.

    5. Re:Operating in Africa by Anonymous Coward · · Score: 0

      Involuntary sterilization under the guise of vaccinations

      Citation needed.

    6. Re:Operating in Africa by Anonymous Coward · · Score: 0

      Do not be rude... do not take Ebola from Africans... it is not beliefs, it is biological needs. If they no longer have Ebola or other diseases, how in hell can they tell each other **you are shit**? Just like dandruff in NYC, no one wants it cured because Africans are used to it since primeval times and People simply have no idea...

  5. of course by Anonymous Coward · · Score: 0

    For a moment there it appeared that self interest had made place for common sense, there was a real threat that this could become a global outbreak. However, the immediate ebola crisis is over, there is no reason to expect the previous status quo not to be reinstated.

  6. Ebola burial practices pinpoints risks .. by nickweller · · Score: 1

    "An early September assessment of burial practices in some of Sierra Leone's Ebola hot spots revealed a host of problems that were probably helping fuel ongoing virus transmission in the country" ref

  7. as other typical tests by houghi · · Score: 1

    "as other typical tests" sounds to me that it would be competition for other companies. It would not be too absurd to think that these companies try to avaoid competition by bribery and other means.

    --
    Don't fight for your country, if your country does not fight for you.
  8. overcoming backwater thinking by harvey+the+nerd · · Score: 1, Interesting

    Combined with IV vitamin C, a powerful viricide, this test could protect world borders. Maimstream medicine never supports tests of IV vitamin C to treat viruses, not since the 1930-40s. Intravenous vitamin C is a great general viricide, extraordinarily successful in early or acute viral infections. Pity they don't use it on Ebola. Read this book online, Injectable Vitamin C by Robert McCracken, PhD, to see what I mean. Also see "Curing the Incurable: Vitamin C, Infectious Diseases, and Toxins" by Thomas Levy, MD (Introduction).

    The life you save may be your own.

    1. Re:overcoming backwater thinking by Anonymous Coward · · Score: 1

      Combined with IV vitamin C, a powerful viricide, this test could protect world borders. Maimstream medicine never supports tests of IV vitamin C to treat viruses, not since the 1930-40s. Intravenous vitamin C is a great general viricide, extraordinarily successful in early or acute viral infections. Pity they don't use it on Ebola. Read this book online, Injectable Vitamin C by Robert McCracken, PhD, to see what I mean. Also see "Curing the Incurable: Vitamin C, Infectious Diseases, and Toxins" by Thomas Levy, MD (Introduction).

      The life you save may be your own.

      Make sure to dilute the vitamin C first, to make it more potent. But the big vitamin companies don't want you to know their miracle cures are even more ffective if you dilute it 10:1 a few dozens times. Also see "Culling the Uneducated: Companies making a buck off the gullible through Homeopathy Vitamin C, Infectious Diseases, and Toxins" by WhackJob, NotARealMD (Introduction).

    2. Re:overcoming backwater thinking by harvey+the+nerd · · Score: 0

      The IV vitamin C is based on high doses, like 700-1500 mg per kg of body weight. Real MD doctors like Klenner, Duke, or Cathcart, Stanford. Vitamin C is very cheap in its bulk USP powder. Maimstream doctors are the ones likely to allow homeopathic vitamin C doses, like less than 60 mg oral, and often cannot even recognize scorbutic patients.

    3. Re:overcoming backwater thinking by Anonymous Coward · · Score: 0

      According to the Mayo Clinic (http://www.mayoclinic.org/drugs-supplements/vitamin-c/safety/hrb-20060322), high doses of vitamin C (and the maximum daily recommended dose is 2g, above which can cause stomach upset and other digestive issues) are associated with "multiple adverse effects. These include blood clotting, death (heart-related), kidney stones, pro-oxidant effects, problems with the digestive system, and red blood cell destruction." You're suggesting that a reasonable single dose for a 175 lb adult, at 1.5g/kg of body weight, would be over 100g. Do you have data on the risk analysis associated with that dosage?

      If the millions of people getting the recommended minimum dose of less than 100mg/day of vitamin C had really been scorbutic for much of their lives, do you believe that they wouldn't be showing symptoms, like swollen gums, joint pain, shortness of breath, easily bruised skin, and jaundice? The thresholds are set such that symptoms go away. If people are asymptomatic, then presumably they feel healthy and able to function and are not in need of additional vitamin C. Science certainly doesn't seem to support (at least on a cursory reading) the notion that doses in excess of 2g/day _reduce_ the overall risk associated with vitamin C intake.

    4. Re:overcoming backwater thinking by cwsumner · · Score: 1

      You are talking about two entirely different things. Avoiding scurvey is a lot different from fighting an invasion of virus organisms. For one thing the virus fighting dosage is not continuous, just temporary.

    5. Re:overcoming backwater thinking by harvey+the+nerd · · Score: 1

      For anybody still reading these exchanges, although there are exclusionary conditions, most people can tolerate high strength IV vitamin C.

      Typically they will quickly get and feel better. The stuffs KILLS acute viruses. Even overrun, terminal cancer patients within a few days of death. The IV vitamin C likely will allow them to temporarily eliminate pain and to be energetic for a day or so.