Dewei Medical Equipment Co., Ltd |
Verified Suppliers
|
|
One Step Chagas Rapid Test 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