FDA Approves New West Nile Test

The U.S. Food and Drug Administration has approved a new test for the detection of West Nile virus in donated blood and organs.

The cobas TaqScreen WNV test is the second test approved by the FDA for detection of the virus, the agency said Friday in a release.

The automated test can detect the genetic material of the virus itself early in the infection, even before the donor’s body has begun to produce antibodies against the virus.

While West Nile virus is most often transmitted to humans by mosquitoes, the virus can also be transmitted by blood transfusion or organ transplantation from infected donors.

So far this year, 58 donors who are possibly positive for the virus have been reported to the Centers for Disease Control and Prevention as of Aug. 21. The CDC said there were 1 million to 3 million cases of West Nile virus in the United States from 1999-2006.

The cobas TaqScreen WNV test, manufactured by Roche Molecular Systems Inc. of Pleasanton, Calif., isn’t intended as an aid in the diagnosis of WNV infection, the agency said.