Expected use
The Chagas Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of T. cruzi infection. Any specimen reactive with the Chagas Ab Combo Rapid Test should be confirmed by alternative test methods and clinical findings.
Summary and explanation
Chagas disease is a zoonotic infection transmitted by insects by the protozoan T. cruzi, which causes a systemic infection in humans with acute manifestations and long-term sequelae. It is estimated that between 16 and 18 million people are infected worldwide and approximately 50,000 die each year from chronic Chagas disease (World Health Organization). Buffy coat examination and xenodiagnosis used to be the most common methods in the diagnosis of acute T. cruzi infection. However, both methods are time consuming or lack sensitivity.
Recently, the serological test has become the mainstay in the diagnosis of Chagas disease. In particular, recombinant antigen-based tests eliminate the false positive reactions commonly seen in native antigen tests. The Rapid Chagas Ab Combo Test is an instant antibody test that detects IgG antibodies to T. cruzi in 15 minutes without the need for instruments. Using the recombinant T. cruzi specific antigen, the test is highly sensitive and specific.
