Celiac Microlisa

Test Kit Type: Celiac ELISA Test Kit
Sensitivity & Specificity: 100%
Feature: Unique Break-away wells
Shelf Life: 15 Months at 2-8°C

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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.

 

Ordering Information

Product Name Pack Size Catalog No.
Celiac Microlisa 96 Tests IR091096

Performance Characteristics (Internal Evaluation) Of Celiac Microlisa Test

1) The performance of Celiac Microlisa has been evaluated in house with fresh as well as frozen samples. The testing has been done with clinical samples, samples from random blood donors, cross reacting samples; RA, CRP, ASO and patients with diseases related to Celiac. The results of in-house studies are as follows:

No. of Samples Status Celiac Microlisa + ve Celiac Microlisa – ve
125 All ELISA +ve 125
994 All EIA -ve 994

Sensitivity: 100%
Specificity: 100%

2)Precision:
Within-run and between-run precisions have been determined by testing 10 replicates of seven specimens : two negative, five celiac antibody positive (a strong, two medium and two weak positive). The C.V.(%) of negative and positive sample values were within 10%.

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