FDA approves H1N1 diagnostic test

July 1, 2010

A new test to diagnose the 2009 strain of the H1N1 influenza virus was approved by the Food and Drug Administration last week.

The test uses molecular biology to detect the virus, and officials hope it will ensure the accuracy of H1N1 testing in various laboratories. It replaces one test FDA authorized for emergency use in April 2009 at the height of the pandemic. The new test is based on a larger sample of H1N1 information, and is more sensitive and specific than the previous model. The test will be able to provide results within four hours.