Intended Use
Celiac Microlisa is an in-vitro qualitative enzyme immunoassay for the detection of anti tTG IgA 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
- Based on Indirect Elisa
- Excellent Sensitivity: 100% and Specificity 100%
- Easy to use on Automated & Semiautomated Processor
- Colour Coded reagents to monitor procedural steps
- Shelf Life : 15 Months at 2-8°C.
- Unique Break-away wells
Principle
Celiac Microlisa test is an enzyme immunoassay based on indirect ELISA.
Activated tissue transglutaminase (human recombinant) immuno-dominant epitopes are coated on the microtiter wells. Specimens and controls are added to the microtiter wells and incubated. Anti-transglutaminase antibodies if present in the specimen, will bind to the specific antigen absorbed on the surface of the wells. The plate is then washed to remove the unbound material. Horseradish proxidase (HRP) conjugated anti-human IgA added to each wells. This conjugate will bind to tTG-Ag-Ab complex present. Finally substrate solution containing chromogen and hydrogen proxide is added to the wells and incubated.A blue colour will develop in proportion to the amount of anti-tranglutaminase antibodies if present in the specimen. The colour reaction is stopped by a stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at wavelength of 450 & 630 nm. If sample does not contain anti-transglutaminase antibody, then enzyme conjugate will not bind and the solution in the well will be either colourless or only a faint background colour develops.