Navigation Links
FDA Approves First Supplemental Test for Chagas Disease

SILVER SPRING, Md., Nov. 18, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first test for use as an additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi (T. cruzi). T. cruzi causes Chagas disease, a serious and potentially fatal parasitic infection.


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.

The Abbott ESA Chagas assay is manufactured by Abbott Laboratories, based in Abbott Park, Ill.

For more information:
Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay)
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Shelly Burgess, 301-796-4651,, Rita Chappelle, 301-796-4672,
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Erwinaze to Treat a Form of Leukemia
2. FDA Approves New York Blood Centers HEMACORD™ for Stem Cell Transplantation
3. FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer
4. FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
5. FDA Approves U.S. Market Return for octagam® Following Octapharmas Implementation of Enhanced Safety Measures
6. FDA Approves First Artificial Aortic Heart Valve Placed Without Open-Heart Surgery
7. FDA Approves First Generic Olanzapine to Treat Schizophrenia, Bipolar Disorder
8. FDA Approves Onfi To Treat Severe Type of Seizures
9. FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
10. FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
11. FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
Post Your Comments:
(Date:11/25/2015)... Nov. 25, 2015  Amgen (NASDAQ: AMGN ) ... (BLA) with the United States ... a biosimilar candidate to Humira ® (adalimumab). Amgen ... submitted to the FDA and represents Amgen,s first BLA ... E. Harper , M.D., executive vice president of Research ...
(Date:11/25/2015)... Nov. 25, 2015 AAIPharma Services Corp./Cambridge ... of at least $15.8  Million to expand its ... NC . The expansion will provide additional ... the growing demands of the pharmaceutical and biotechnology ... expansion will provide up to 40,000 square feet ...
(Date:11/25/2015)... MELVILLE, N.Y. , Nov. 25, 2015  Henry ... products and services to office-based dental, medical and animal ... Dental (GNYDM) Meeting the Henry Schein ConnectDental® Pavilion ... industry,s broadest array of open solutions designed to help ... Click here for a schedule of ...
Breaking Medicine Technology:
(Date:11/25/2015)... Ill. (PRWEB) , ... November 25, 2015 , ... ... and potentially more aggressive than those found on mammography, according to a study ... findings of additional cancers not seen on mammography may necessitate a change in ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday season ... and pleasing the palates of attendees is of the utmost importance. Whether you ... seasonal get-together, give these recipes a try this holiday season. , Turkey Croquettes ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... recognized once again for its stellar workplace culture with the company’s Cincinnati office ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati Business Courier’s ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... Dr. John ... to learn more about hair loss treatment with the Capillus272™ Pro laser therapy cap. ... solution for thicker and fuller hair, without the need for surgery, prescription pills, or ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... On November ... United States District Court of Connecticut on behalf of a home health care worker ... all current or former home health care workers employed by Humana, Inc., Humana at ...
Breaking Medicine News(10 mins):