Abbott introduces the first FDA-approved supplemental blood test for Chagas disease
Posted: 21 November 2011 | | No comments yet
Abbott received approval from the U.S. FDA for a new Chagas in vitro diagnostic test…
Abbott received approval from the U.S. Food and Drug Administration (FDA) for a new Chagas in vitro diagnostic test. The ABBOTT ESA Chagas is the first FDA-approved supplemental test that detects antibodies to Trypanosoma cruzi (T. cruzi), a parasite found only in the Americas and commonly acquired through contact with the blood-sucking triatomine, also known as a “kissing bug.” The test will be used as an additional, more specific test on human serum or plasma specimens found repeatedly reactive using a licensed screening test.
According to the U.S. Centers for Disease Control and Prevention (CDC), as many as 11 million people worldwide are infected with Chagas disease. Chagas disease belongs to a group of neglected tropical diseases (NTD) that disproportionately affects the world’s poor and rural populations. In the United States, more than 300,000 individuals are estimated to be infected with Chagas disease.
Amid concerns about the transmission of Chagas disease through blood, the FDA mandated donor screening in 2007. The American Association of Blood Banks (AABB) Chagas Biovigilance Network reports that nearly 1,500 donors with Chagas disease have been identified in the four years since mandatory donor screening was implemented.
“Chagas disease can cause significant and debilitating symptoms for those infected,” said John Coulter, divisional vice president, Diagnostics, Abbott. “The new ABBOTT ESA Chagas test provides organizations that screen blood with an approved testing method to help keep the blood supply safe and enable them to confidently counsel infected donors.”
Chagas disease is caused by the parasite T. cruzi, which is transmitted to animals and people by insects through contact with the feces of an infected triatomine bug. Infection also occurs congenitally, through transfusions of contaminated blood products, or through an organ transplant from an infected donor. If left untreated, Chagas disease develops from an acute to a chronic illness, which could result in constipation, digestive problems, abdomen pain, and abnormal heart rhythms or heart failure, which may result in death. Chagas disease is endemic throughout much of Mexico, Central America and South America.
Important Product Usage and Safety Information
ABBOTT ESA Chagas is an in vitro enzyme strip assay (ESA) intended for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum and plasma specimens. The assay is intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed screening test for antibodies to T. cruzi. It is not intended for use on cord blood specimens or for the laboratory diagnosis of Chagas infection. This assay has not been validated for use with plasmapheresis specimens, cadaveric specimens, pooled specimens, umbilical cord blood, or bodily fluids such as urine, saliva, semen, amniotic fluid, cerebrospinal fluid, or pleural fluid. These specimens should not be tested using ABBOTT ESA Chagas. This product contains human sourced and /or potentially infectious components.
For complete information, see the assay specific package insert on www.abbottdiagnostics.com.
About Neglected Diseases
Chagas disease belongs to a group of neglected tropical diseases (NTDs) that disproportionately affect the world’s poor and rural populations. According to the World Health Organization (WHO), more than a billion people or one-sixth of the global population suffer from one or more NTDs. Important progress in the prevention, diagnosis and treatment of NTDs is occurring through public-private partnerships, drug donations from pharmaceutical companies, increased country and international agency commitment, and more effective intervention strategies.