Chagas Rapid Test Cassette (Serum/Plasma) With CE

A rapid test for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human’s serum or plasma specimen. For professional in vitro diagnostic use only.

Application:

The Chagas Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human 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 Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Description:

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 xenodiagnosis used to be the most commonly methods in the diagnosis of acute T. cruzi infection. However, both methods are either time consuming or lack of 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 .

The Chagas Rapid Test is an instant antibody test which detects IgG antibodies the T. cruzi within 15 minutes without any instrument requirements. By utilizing T. cruzi specific recombinant antigen, the test is highly sensitive and specific.

How to use?

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15- 30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the cassette on a clean and level surface.Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 ul) to the specimen area, then add 2 drops of buffer (approximately 80 ul),and start the timer, see illustration below.

3. Wait for the colored line(s) to appear. The test result should be read at 15 minutes.Do not interpret the result after 20 minutes.

PRINCIPLE