Diagnos Celiac Card

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.

Absence of a colored band in the test region indicates a non-reactive test result. A red procedural control line should always develop at ‘C’ region to indicate that the test has been performed properly.

Performance Characteristics

In House evaluation: Sensitivity and Specificity studies were carried out on samples, fresh as well as frozen from low as well as high risk groups. The clinical sensitivity of the Diagnos Celiac Card was determined using 273 positive sera from patients with celiac disease having = 200RU/ml (samples taken from Pediatric Deptt., AIIMS, New Delhi) and the specificity was checked with a panel of 2000 plasma and serum sample which were ELISA negative for Celiac antibodies. The results obtained are as follows
Sensitivity: 99.26%
Specificity: 99.50%

Precision: Within-run and between-run precisions have been determined by testing 10 replicates of 6 specimens: one negative and five celiac antibody positive; two weak and two moderate and one strong positive. The C.V (%) of negative, weak positive, moderate positive and strong positive samples were within 10% of the time.

Ordering Information