Colds and flu

26 May 2010

Simplexa H1N1 Test Approved

Detects 'swine flu' infection

This article has not necessarily been edited by Health24.

MONDAY, May 24 (HealthDay News) -- The Simplexa diagnostic test to detect infection with the H1N1 "swine" flu virus has been approved by the U.S. Food and Drug Administration, the agency said Monday in a news release.

Prior to the approval, the test was available under the agency's Emergency Use Authorization, which allows the FDA to sanction use of unapproved medical products during a public health emergency. The agency declared such an emergency on April 26, 2009, and the new approval permits the test's continued use after the emergency declaration expires.

The test uses nasal specimens to detect the presence of the H1N1 virus, although it does not indicate the infection's severity.

The first wave of H1N1 hit the United States in the spring of 2009, followed by a second wave last fall. As many as 88 million people were infected in the United States through March 13, the FDA said.

The Simplexa test is produced by Focus Diagnostics Inc., of Cypress, Calif.

More information

The U.S. Centers for Disease Control and Prevention has more about H1N1 flu.


Read Health24’s Comments Policy

Comment on this story
Comments have been closed for this article.

Ask the Expert

Flu expert

Dr Heidi van Deventer completed her MBChB (Bachelor of Medicine and Bachelor of Surgery) degree in 2004 at the University of Stellenbosch.
She has additional training in ACLS (Advanced Cardiac Life Support) and PALS (Paediatric Advanced Life Support) as well as biostatistics and epidemiology.

Dr Van Deventer is currently working as a researcher at the Desmond Tutu Tuberculosis Centre at the University of Stellenbosch.

Still have a question?

Get free advice from our panel of experts

The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.

* You must accept our condition

Forum Rules