Navigation Links
FDA Approves First Supplemental Test for Chagas Disease
Date:11/18/2011

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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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, shelly.burgess@fda.hhs.gov, Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
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:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... Jan. 20, 2017  Palladian Health, a leading ... the launch of an opioid management program which ... opioids and helps stem the growing tide of ... to treat chronic non-cancer pain (back pain, neck ... and lack of evidence regarding long-term effectiveness. ...
(Date:1/20/2017)... VAE, January 20, 2017 ... Bedarf an Nothilfe   Die internationale humanitäre Stadt ... Hilfsgüter zu schaffen   Seine Hoheit ... der VAE sowie Herrscher von Dubai ... Stadt der Hilfe (International Humanitarian City IHC) zu verdreifachen, ...
(Date:1/19/2017)... LONDON , Jan. 19, 2017 ... 2022 Summary GlobalData,s new report, "Germany Cataract ... data on the Germany Cataract Surgery Devices market. The ... (in units) and average prices (USD) within market segements ... The report also provides company shares and distribution shares ...
Breaking Medicine Technology:
(Date:1/21/2017)... ... January 21, 2017 , ... "ProDOF is the perfect set of tools for video editors ... in a scene," said Christina Austin - CEO of Pixel Film Studios. , Video ... create the illusion of a DSLR racking focus from one area into the next. ...
(Date:1/21/2017)... ... January 21, 2017 , ... Pacifica Graduate ... the electrifying line-up of events for its annual meeting “Coming Home 2017,” an ... “Coming Home 2017” will be held on Friday January 27 through Sunday, ...
(Date:1/21/2017)... Pekin, IL (PRWEB) , ... January 21, 2017 , ... ... disorders. Even when individuals experience the freedom of recovery, they often feel shame for ... abuse and post-traumatic stress disorder (PTSD). In the workshop, “Rising Strong in Life After ...
(Date:1/20/2017)... ... 20, 2017 , ... A new partnership between Goodwill® and Roadie, Inc. aims ... need, from clothes to couches to dressers and bicycles. Roadie — the national on-the-way ... nearest Goodwill donation center through February 28th. , “January is an exciting time ...
(Date:1/20/2017)... ... January 20, 2017 , ... Doctor C LLC, a company based ... ECRM trade show to continue the marketing and distribution of its product, The Right ... providing 400 percent better absorption than traditional vitamin C supplements. At the trade show, ...
Breaking Medicine News(10 mins):