REF:

C3109 (Cassette)

INTENDED PURPOSE:

NOVAtest® Chagas IgG Antibody Test is a immunoassay that uses immuno-capture method for the qualitative detection of IgG antibodies against to Trypanosoma cruzi (T.cruzi) in human serum, plasma and whole blood specimens. It is intended to be used as an aid to diagnosis chagas disease.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Chagas disease, also known as American trypanosomiasis, is a potentially life-threatening illness caused by the protozoan parasite Trypanosoma cruzi, which causes a systemic infection of humans with acute manifestations and long-term sequelae. With an annual incidence of 28,000 cases in the region of the America, it is estimated that chagas disease affects around six million people and causes nearly 12,000 deaths each year.

During the acute phase of infection, the diagnosis of chagas disease can be made by parasitological tests. Nevertheless, the majority of T.cruzi acute infections progresses onto chronic phase, throughout which parasitaemia is low and intermittent. The current WHO/PAHO recommendation is to use at least two serological tests based on different technical principles.

The Chagas IgG Antibody Test is an instant antibody test which detects anti-T.cruzi IgG antibodies within 15 minutes without any instrument requirements.