The FDA has approvedthe first West Nile Virus blood test to screen donors of blood, organs, cells, and tissues.
“This new test will help protect patients who receive blood and other such products against West Nile infection,” states the FDA in a news release. The test checks for viral genetic material.
To date, there have been 30 documented cases of people who most likely acquired West Nile virus from a blood transfusion, including nine who died.
"This approval is the result of a tremendous cooperative effort among FDA, other public health agencies, the test kit manufacturers and the blood industry," says Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research, in the news release.
"To develop an investigational test to screen blood, tissue and organ donors, and to get this test in blood banks throughout the country, and then licensed this quickly is a remarkable achievement for public health and patient safety,” Goodman says.
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About West Nile Virus
West Nilevirus is typically transmitted to humans by mosquito bites.
It was first detected in the U.S. in 1999 and has reoccurred each year for seven consecutive years, causing close to 20,000 human cases of disease and at least 762 deaths since 2002.
It is estimated that between 1 million and 2 million people have been infected with West Nile virus, according to the FDA.
Not everyone who is infected with West Nile virus becomes ill.
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West Nile and Blood Donation
In 2002, it was discovered that West Nile virus could be transmitted in blood, and an urgent effort to develop a blood test began.
With support from the FDA, the CDC, and the National Institutes of Health, manufacturers developed investigational West Nile tests that were rapidly put in place both to evaluate their effectiveness and as an interim measure to protect the blood supply.
Blood banks across the U.S. participated in these efforts, resulting in the detection and removal of approximately 1,600 infected donations, safeguarding the nation’s blood supply and providing the needed data for today's approval, says the FDA.
By Miranda Hitti, reviewed by Michael W. Smith, MD
SOURCE: News release, FDA.
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