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The first test to diagnose West Nile virus infections has been approved by the Food and Drug Administration.
The West Nile virus IgM Capture ELISA is intended to diagnose patients who have clinical symptoms of viral encephalitis/meningitis. The test is manufactured by PanBio Limited in Windsor, Australia.
"Emerging infectious diseases such as West Nile virus present a challenge to the public health community," said Tommy Thompson, secretary of Health and Human Services. "When industry and government collaborate closely to meet a public health need, the resulting new technology will strengthen our joint efforts to confront diseases earlier and should lower rates of infection."
The new test works by detecting the levels of a particular type of antibody, IgM, to the disease in a patient's serum. IgM antibodies can be detected within the first few days of the illness.
The test was evaluated by using 1,000 patients' sera, which were tested at four different clinical sites. The test correctly identified the antibody in up to 90 to 99 percent of West Nile virus disease cases.
But federal experts said that even though the new test is a valuable aid in diagnosing West Nile virus, the results should be confirmed by additional testing because of the similarities between West Nile virus and other viruses in the same family.
West Nile virus is a mosquito-borne virus that first appeared in the United States in 1999. While the virus often presents as a mild infection that clears without further treatment, some patients develop severe infection resulting in neurological disease and even death.
The disease is most prevalent during the peak mosquito season, which is expected to begin in July and end in October. Over the past several years, the virus has spread in numbers as well as geography, and it now covers most of the continental United States.
In mid June, blood testing centers began testing blood donations for West Nile virus, using experimental test kits that the FDA has evaluated and permitted to be used. The screening has already successfully identified the first human West Nile virus infection in a blood donor without symptoms.
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