The Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with T. cruzi. Any reactive specimen with the Chagas Ab Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.

Chagas disease is an insect-borne, zoonotic infection by the protozoan T. cruzi, which causes a systemic infection of humans with acute manifestations and long-term sequelae. It is estimated that 16-18 million individuals are infected worldwide, and roughly 50,000 people die each year from chronic Chagas disease (World Health Organization).

Buffy coat examination and xenodiagnoses used to be the most commonly methods in the diagnosis of acute T. cruzi infection. However, both methods are either time consuming or lack sensitivity. Recently, serological test becomes the mainstay in the diagnosis of Chagas’s disease. In particularly, recombinant antigen-based tests eliminate false-positive reactions which are commonly seen in the native antigen tests.

“Chagas disease is named after the Brazilian physician Carlos Chagas, who discovered the disease in 1909. It is caused by the parasite Trypanosoma cruzi, which is transmitted to animals and people by insect vectors and is found only in the Americas (mainly, in rural areas of Latin America where poverty is widespread). Chagas disease (T. cruzi infection) is also referred to as American trypanosomiasis.” (1)