One Step Chagas Rapid Test Kit Diagnostic Igg Anti Trypanosoma Cruzi Whole Blood

INTENDED USE
The Chagas 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 infection with T. cruzi. Any reactive specimen with the Chagas Rapid Test must be confirmed with alternative testing method(s) and clinical finding.
For professional use only.
For in vitro diagnostic use only.

INTRODUCTION
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)1.
Buffy coat examination and xenodiagnosis used to be the most commonly used methods2,3 in the diagnosis of acute T. cruzi infection. However, both methods are either time consuming or lack sensitivity. Recently, serological tests have become the mainstay in the diagnosis of Chagas's disease. In particular, recombinant antigen based tests eliminate false-positive reactions which are commonly seen in the native antigen tests.
The Chagas Ab Combo Rapid Test is an instant antibody test which detects IgG antibodies to T. cruzi within 15 minutes without any instrument requirements. By utilizing T. cruzi specific recombinant antigen, the test is highly sensitive and specific.

PRINCIPLE
The Chagas Rapid Test is a lateral flow chromatographic immunoassay based on the principle of indirect immunoassay. The test cassette consists of: 1) a burgundy coloured conjugate pad containing Protein A conjugated with colloid gold (Protein A conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with recombinant T. cruzi antigens, and the C band is pre-coated with anti-Protein A antibodies.

MAIN CONTENTS
• Rapid test cassette with desiccant.
• Buffer
• Disposable pipettes
• Package insert

SAMPLE COLLECTION

• The Chagas Rapid Test is intended for use with human whole blood, serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.