Reasons for Emergency Use Authorization of Swine Flu Test Kit

April 29, 2009 1:45 AM ET

A public health emergency has been declared by the Secretary of Health and Human Services because of the 2009 outbreak of swine influenza (swine flu).

Due to a significant increase in demand for swine influenza testing throughout the country, the Centers for Disease Control and Prevention (CDC) has developed the Swine Influenza Virus Real-time RT-PCR Detection Panel (Swine Flu Test Kit) for the presumptive presence of swine influenza A (H1N1) virus from the nasal or nasopharyngeal swab.

Currently, there are no FDA-cleared tests for the swine influenza A (H1N1) strain in the United States. Therefore, the Food and Drug Administration (FDA) has authorized the emergency use of Swine Flu Test Kit to test for the presence of swine flu virus. We don’t know for sure if this test can identify all people who may get sick with swine flu.
This test could help to determine whether you may be infected with the swine flu virus, so that public health officials could quickly identify a case and limit its spread. Also, the results of this test, along with other information, may also help your doctor take better care of you.

*Any significant new findings observed during the course of the emergency use of Swine Influenza Test Kit will be made available on the CDC H1N1 Flu website.

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