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T.Cruzi IgG Rapid Test

T.Cruzi IgG test cassette is rapid immunoassay, intended to be used to detect the infection of Trypanosoma Cruzi virus, as an aid in the diagnosis of Chagas disease.

Chagas IgG Rapid Test Kit

Intended Use

The Trypanosoma cruzi IgG Chagas Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibody to the T.Cruzi virus 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 infection.

This T. Cruzi Chagas IgG Rapid Test cassette is an instant IgG antibody test, which detects IgG antibodies to the T. cruzi within 15 minutes without any extra instrument. T. cruzi specific recombinant antigens are adopted, which enables our test kit to detect the T.Cruzi antibodies with high sensitivity and specificity.

T.Cruzi IgG Rapid Test Principle

The Chagas IgG Rapid Test is based on the principle of indirect immunoassay. The test cassette consists of: 1) a colored conjugate pad containing Protein A conjugated with colloid gold, 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.

When an adequate volume of test specimen is added to the sample well, the IgG antibodies to T.Cruzi, if present in the specimen, will bind to the Protein A conjugates. The immunocomplex is then captured on the membrane by the pre-coated T.Cruzi antigen when the compounds moves along the strip under the capillary effect, forming a burgundy colored T band, indicating Chagas IgG positive.

Trypanosomiasis Disease

Trypanosoma cruzi is a species of parasitic euglenoids. The trypanosomes characteristically bore the human tissues and primarily feed on blood and lymph. This behaviour causes the disease of trypanosomiasis in humans, known as American trypanosomiasis or Chagas Disease, which causes a systemic infection with acute manifestations and long term sequelae, even death.

Early infections are treatable with the medication benznidazole or nifurtimox. Medication nearly always results in a cure if given in early stage, but becomes the less effective the later the treatment is administered. So, early diagnosis is helpful to reduce the bad effect of this disease.

Trypanosoma Cruzi Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
CHAG 411 T.cruzi IgG Chagas Test Card serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
How to Use

T.cruzi IgG Chagas Test Card

General Information

(IVD Kit »-» Arthropod Borne Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:CHAG 411
Description:T.cruzi IgG Chagas Test Card
Category:Arthropod Borne Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Lateral Flow Indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Specimen Diluents;
  • Instruction leaflet.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

serum/WB/plasma Storage Condition

Test specimens as soon as possible after collecting.

The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times.

Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Indirect

GICA Indirect Method Illustration

In the lateral flow indirect chromatographic rapid test, recombinant or purified antigens are immobilized in the test band region. In the end of the Conjugate pad of the membrane strip where the samples are supposed to be added, rabbit or mouse anti-human IgG antibodies conjugated with colloidal gold particles is embedded.

During the testing process, specimen is added to the end of the membrane strip. anti-IgG colloidal gold particles resolve into the specimen, where the anti-IgG conjugate will react and bound with the target IgG antibody, if present.

This complex of IgG and anti-IgG will move along the membrane strip to the testing band region, under capillary effect, where the immobilized antigen captures the IgG antibody. When the antigen-IgG-Anti-IgG complex accumulate on the test band region, the congregated colloidal gold particle will develop red or pink color, indicating there are target IgG antibodies in the specimen.

If there is no target IgG antibody in the specimen, the secondary anti-IgG conjugate will not bind to the immobilized antigen in the test band region, and no color will develop.

As a procedural quality control, a secondary antibody or recombinant antigen will be immobilized in the control band region. When the specimen climb to this region, the unbound anti-IgG colloidal gold particle will be captured, thus a red band will always develop. This inner control process ensure that enough specimen is added, proper testing procedure has been followed, and the reagent has not deteriorated.

Information | Packing | Specimen | Principle