Intended Use
Diagnos Celiac Card is a visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of anti tTG IgA, IgG & IgM antibodies in Human Serum or Plasma. The assay is intended to be used as an aid in the recognition and diagnosis of Celiac disease.
Salient Features
- Rapid, Visual and Qualitative Antibody Test.
- Excellent Sensitivity: 99.26% & Specificity: 99.50%.
- Results within 20 minutes.
- Long Shelf life 24 months at 2-8°C.
- Bio-hazard free, fully covered, see-through Device.
- No instrument required.
Principle
Diagnos Celiac Card is a one step immunoassay based on the antigen capture, or “sandwich” principle. The method uses tissue transglutaminase (tTG) antigen conjugated to colloidal gold and the same antigen is immobilized on a nitrocellulose strip. The diluted test sample is introduced to and flows laterally through an absorbent pad where it mixes with the signal reagent. If the sample contains celiac disease specific antibody, the colloidal gold – antigen conjugate binds to the antibody, forming an antibody-antigen-colloidal gold complex. The complex then migrates through the nitrocellulose strip by capillary action. When the complex meets the line of immobilized tTG antigen (Test line) “T”, the complex is trapped forming an antigen-antibody-antigen colloidal gold complex. This forms a pink pad indicating the sample is reactive foe celiac disease specific antibody.