AllTest Chagas Rapid Test Cassette

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

Applications:

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 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?

For ICHA-302:

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.

For ICHA-402:

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.
For Serum or Plasma specimen: 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.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 ul) to the specimen area, then add 2 drops of buffer (approximately 80 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 50 ul of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80 ul) and start the timer. See illustration below.
· To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 ul) to fall into the specimen area of test cassette, 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.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE: Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the test region (T).

NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Chagas antibodies present in the specimen. Therefore, any shade of red in the test region should be considered positive.

NEGATIVE : One color line appears in the control region (C). No apparent red or pink line appears in the test region.

INVALID: Controlline fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.