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faster west nile diagnostic test gets fda nod

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    Faster West Nile diagnostic test gets FDA nod
    The rapid-acting blood test is indicated for patients with encephalitis or meningitis.
    By Susan J. Landers, AMNews staff. Sept. 1, 2003.


    Washington -- The Food and Drug Administration has approved a new rapid-acting test for West Nile virus just as the number of mosquitoes carrying the potentially deadly virus peaks in the United States.

    As of mid-August, the Centers for Disease Control and Prevention reported 446 human cases of West Nile with 10 deaths. Last year 4,156 people were infected and 284 died.

    Nearly half the states are reporting human West Nile virus cases so far this year with the majority in Colorado, which is reporting 247 cases including six deaths. Colorado reported no human cases last year.

    The new test, developed by PANBio an Australian medical diagnostics company, takes about two hours to detect antibodies to the virus in the patient's blood. Earlier tests took two days, and there was often a backlog of cases pushing the waiting time for results to as long as two weeks.

    The test, West Nile Virus IgM Capture ELISA, is intended for use in patients with clinical symptoms of viral encephalitis or meningitis. It costs about $25.

    The new test was evaluated on more than 1,000 patients at four clinical sites and correctly identified antibody in 90% to 99% of West Nile virus cases, according to the FDA. However, given similarities with other viruses, there is still a need to confirm positive results with an additional test.

    Although most cases of West Nile are mild and are likely not even identified, approximately 20% of those infected with the virus will develop a range of symptoms that include nausea, headache and rash. One in 150 infections, primarily among the elderly, chronically ill and those with weak immune systems, can develop into fatal encephalitis and meningitis.

    It is estimated that as many as 200,000 Americans may have been exposed to West Nile since 1999 when it first appeared in this country.

    The FDA has also been encouraging the development of screening tests for blood donors. In mid-June, blood testing centers began testing the blood supply for West Nile virus using experimental test kits that the FDA has evaluated and permitted to be used. The new procedure has identified the first human West Nile virus infection in an asymptomatic donor, according to the FDA
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