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FDA Approves First Chagas Disease Blood Test

On December 13, 2006, the U.S. Food and Drug Administration (FDA) approved a first-ever test to screen blood donors for a blood-borne parasitic disease known as Chagas disease.

The disease, named for Brazilian physician Carlos Chagas who discovered it in 1909, is caused by the parasite Trypanosoma cruzi. The parasite is typically transmitted to animals and humans by blood-sucking triatomine bugs, known as “kissing bugs.” The parasites can also be transmitted a number of other ways: from pregnant mother to child, by organ transplants or through blood transfusions.

The new test, ORTHO® T. cruzi ELISA Test System, detects antibodies to T. cruzi. In FDA-reviewed studies, the test was accurate 99% or more of the time. It is licensed by Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company headquartered in Raritan, NJ. Major U.S. blood banks have indicated their willingness to swiftly implement the new test.

Infection with Chagas is life-long. The disease can trigger a range of symptoms, depending on its phase. The acute phase is characterized by mild, flulike symptoms, including fever, fatigue, body aches and headaches and the presence of a skin rash. It usually last a few weeks or months. In the chronic phase, which can last decades, there are often no symptoms. However, complications include damage to the heart, esophagus and colon. It some cases, it can be fatal. People with weakened immune systems and recipients of organ transplants are particularly vulnerable to complications.

Although the disease has been found predominately in rural areas of Latin America, the influx of potentially infected people from Mexico and countries of Central and South America has led to an increase in U.S. cases. These cases have drawn the attention of U.S. health officials at the Centers for Disease Control and Prevention (CDC) and the FDA.

The CDC estimates that as many as 11 million people in Latin America are currently infected by Chagas disease, most of whom are undiagnosed. The parasite causes 50,000 deaths annually worldwide. Roughly, 100,000 people in the U.S. could be infected with Chagas, according to the CDC.

The test will be used to screen whole blood donations, and plasma and serum samples from organ, cell and tissue donors. It has not yet been approved to diagnose the disease in the U.S.

“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 Jay Epstein, MD, Director of the Office of Blood Research and Review in FDA’s Center for Biologics Evaluation and Research.

Click here to read the entire FDA release.

Source: FDA news release dated December 13, 2006, and The New York Times, December 14, 2006


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