First West Nile Virus Test Cleared For Use
The U.S. Food and Drug Administration (FDA) has cleared the first test for use as an aid in the clinical laboratory diagnosis of West Nile virus infection. It is expected the test will help doctors diagnose patients who have the clinical symptoms consistent with viral encephalitis/meningitis.
“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 test is manufactured by PanBio, an Australian company with U.S. operations in Maryland, and should soon be available to labs for $6.50.
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 onset of illness and can assist in the diagnosis of these patients.
The FDA’s review found that the test correctly identified the antibody in up to 90 percent to 99 percent of West Nile virus cases. The agency cautions, however, that this test is considered presumptive and should be confirmed by more specific testing.
West Nile virus is a mosquito borne virus which first appeared in the United States in 1999. The disease is most prevalent during the peak mosquito season which begins in July and ends in October.
Last year more than 4,000 West Nile virus cases were reported with the virus reaching 44 states. Only two cases have been reported this year – one in South Carolina and one in Texas.
While the virus often appears as a mild infection that clears up without further treatment, some patients develop severe infection resulting in neurological disease and even death.
Provided by theEnvironmental News Service.