We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement
FDA Approves First Supplemental Test for Chagas Disease
News

FDA Approves First Supplemental Test for Chagas Disease

FDA Approves First Supplemental Test for Chagas Disease
News

FDA Approves First Supplemental Test for Chagas Disease

Read time:
 

Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "FDA Approves First Supplemental Test for Chagas Disease"

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

The test, called the ABBOTT ESA Chagas [Trypanosoma cruzi (E. coli, Recombinant) Antigen], is an in vitro enzyme strip assay for the qualitative detection of antibodies to T. cruzi. There are currently two donor screening tests licensed to detect antibodies to T. cruzi; however, this will be the first test licensed as a supplemental test.

“This test will help health care professionals to provide counseling to donors with positive screening test results,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Chagas disease is mainly spread by blood-sucking insects infected with T. cruzi. Chagas disease can also be spread through blood transfusion, organ transplants, and from mother to unborn child. The estimated number of persons living in the United States infected with T. cruzi, and at risk for developing Chagas disease, is 300,000 or more.

More than 5,000 donors with positive test results on a screening test have been identified since national screening of the blood supply was instituted in early 2007.

Advertisement