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Diagnostic HYBRIDS test is not approved to detect swine flu virus

“The D3 Ultra kit has been shown to detect the 2009 H1N1 influenza A virus in two culture isolates; the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza A virus have not been established,” the company stated in a press release. “The D3 Ultra kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.”

Updated

ATHENS, Ohio — Diagnostic HYBRIDS has corrected a release that claimed the U.S. Food & Drug Administration had approved its D3 Ultra test kit to detect the swine flu virus.

“The D3 Ultra kit has been shown to detect the 2009 H1N1 influenza A virus in two culture isolates; the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza A virus have not been established,” the company stated in a press release. “The D3 Ultra kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.”

The swine flu, or Novel H1N1, a type of Influenza A, is creeping around the globe, according to the World Health Organization, which signaled on June 11 that the virus is causing a pandemic. The novel virus first was detected in the United States in April, according to the Centers for Disease Control and Prevention (CDC) in Atlanta.

So far, most Americans who have gotten sick from Novel H1N1 have experienced mild symptoms and recovered without hospitalization, the CDC says. However, 556 people in the United States who had compromised immune systems have died from the virus, as of Aug. 22. Health officials are worried that the virus will mutate further and cause severe symptoms and a lot more deaths.

Several companies have been developing vaccines for Novel H1N1, and several companies make anti-viral medications that can help lessen flu symptoms. Diagnostic HYBRIDS invents, develops and makes test kits and other diagnostic and analytical products for a range of viral respiratory diseases, herpes virus infections, and other specific viral and thyroid diseases. Its D3 Ultra test kit can detect many types of flu viruses from respiratory specimens.