The first test to screen potential blood donors for a tropical disease that has stealthily infected as many as 100,000 Hispanic immigrants gained federal approval Wednesday.
The Food and Drug Administration said the Chagas test, made by Ortho-Clinical Diagnostics, can help prevent donors from unwittingly passing along the sometimes fatal disease.
“The availability of this test offers an important new safety measure to protect recipients of blood, organs and tissues against a potentially very serious, though uncommon infection,” said Dr. Jay Epstein, director of FDA’s Office of Blood Research and Review.
Chagas disease is caused by the parasite Trypanosoma cruzi, which affects millions of people in parts of Mexico and Central and South America. According to the Centers for Disease Control and Prevention is kills 50,000 people a year.
Chagas is spread mostly by blood-sucking “kissing bugs” that live in the cracks of thatch-roofed mud walled homes, only to emerge at night and bite sleepers. It’s also spread by mothers to their unborn children and through transfusions and organ transplants.
Since 1987 there have been five known transfusion-spread cases of Chagas in the United States and two in Canada. Blood banks have eagerly awaited this test as they look to the nation’s burgeoning Hispanic population to expand their pool of donors.
The FDA said studies it reviewed showed the test was 99 percent accurate or more, detecting 198 out of 199 blood specimens from individuals believed to be infected. In field trials of over 70,000 donor samples, the number of individuals falsely identified as positive was extremely small, only two to three per 100,000 test results.
