Another ‘Swine Flu’ Test Gets FDA Approval; Flu Shots for All Children Urged

The Food and Drug Administration has granted emergency approval to another diagnostic test for the 2009 H1N1 influenza virus, also called “swine flu,” as health officials encourage all children to get flu shots this fall.

The Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is made by Focus Diagnostics of Cypress, Calif. It is the third H1N1 diagnostic test the FDA has approved under an Emergency Use Authorization since the H1N1 public health emergency was declared in April.

The deadly strain of influenza was first recognized in Mexico in April and has quickly swept across the world, infecting millions in nearly every corner of the globe. In the United States, as of today, H1N1 has been linked to 302 deaths and more than 43,000 confirmed cases. However, officials say the confirmed cases likely are just the tip of the iceberg and that as many as one million Americans may be infected and either not know it or are not seeking medical treatment.

With the FDA emergency approval, Focus Diagnostics can now distribute the test to laboratories that have been certified to perform high-complexity tests. The test is not typically utilized in a doctor’s office, but rather performed in laboratories with the necessary medical equipment and expertise.

The diagnostic test amplifies the viral genetic material taken from swabs of the nose or throat, or from nasal discharges, the FDA said. While the test can detect whether a person is carrying the H1N1 virus, it does not indicate the stage of the infection, meaning if it is advanced or at an early stage.

Under an emergency use authorization, the FDA can give manufacturers permission to release unapproved medical products and devices in the event of a public health emergency. The permission lasts only as long as the declaration of emergency or until the FDA revokes the authorization.

More Flu Shots Called For

Meanwhile, in other H1N1 influenza virus news, the Centers for Disease Control and Prevention is saying today that all U.S. children aged six months to 18 years should get a seasonal influenza vaccine every year. Doing so is designed to stop the spread among young children, who are among those most at risk of developing severe, deadly complications from H1N1 infections. The frail, elderly, and those with weakened immune systems are also among those who are more likely to suffer severe problems if infected.

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