Intended Use
Celiac Self-Test is a visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of anti tTG IgA, IgG & IgM antibodies in Human Whole Blood/ Serum /Plasma. The assay is intended to be used as an aid in the recognition and diagnosis of Celiac disease. This test is intended to be for home use with self-collected whole blood specimens from individuals aged 18 years or above (or collected by adults for individuals below 18 years of age) as well as for professional use with collected venous Whole Blood/ Serum/ Plasma samples. This test is for in vitro diagnostic use only and is designed as an aid in the early diagnosis of celiac disease in patients with clinical symptoms.
Salient Features
- Rapid Visual and sensitive one step test for the Qualitative Detection of Celiac disease associated IgM, IgG & IgA antibodies in Human whole blood/Serum/Plasma.
- Finger prick sample can be used.
- Single test pack.
- All material to perform the test & its disposal are provided with the kit.
- Based on Sandwich principle.
- Reliable diagnosis of Celiac disease.
- 100% Sensitivity & 100 % Specificity.
- Shelf life: 30 months at 2-30 °C.
PRINCIPLE (ANTIGEN-ANTIBODY REACTION)
Celiac Self Test 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 band indicating the sample is reactive for celiac disease specific antibody. Absence of a coloured 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.