Chagas Diagnostic Test Detects Antibodies to Trypanosoma cruzi

A new Chagas in vitro diagnostic test will be used as an additional, more specific test on human serum or plasma specimens found repeatedly reactive using a licensed screening test.

The Abbott ESA Chagas is the first Food and Drug Administration (FDA; Silver Spring, MD, USA)-approved supplemental test that detects antibodies to Trypanosoma cruzi. It is an in vitro enzyme strip assay (ESA) intended for the qualitative detection of antibodies to T. cruzi in human serum and plasma specimens.

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 (Triatominae) 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.

The US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) reports that 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

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.

Related Links:
Food and Drug Administration
US Centers for Disease Control and Prevention