4044 – Anti-hu tTG IgG

Intended Purpose

The Anti-hu tTG IgG is a quantitative immunoassay for the determination of IgG antibodies against tissue transglutaminase in human serum. The Anti-hu tTG IgG is intended as an aid in the diagnosis of celiac disease in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Celiac disease or gluten-sensitivity is characterized by small intestinal damages leading to a so-called “flat” mucosa. Due to these extensive lesions, malabsorption occurs frequently accompanied with a depletion of key nutrients. The alcohol soluble fraction of gluten, gliadin, a substrate of tissue transglutaminase (tTG), represents a causative agent of celiac disease, by stimulating an inflammatory process in the small intestine. Cellular and humoral immune responses are probably triggered by the cross linking of gliadin into high molecular complexes.

The diagnosis of celiac disease involves small intestine biopsy showing a “flat” mucosa prior to a gluten-free diet, which is then followed by reconstitution of the mucosa after onset of the diet. Determination of IgG and IgA to deamidated gliadin by ELISA as well as the detection of Human endomysial autoantigens (EmA) IgA has been considered as the main serological parameters for celiac disease so far.

Serological method of celiac disease diagnosis includes the detection of IgA and IgG antibodies to tTG and deamidated gliadin. IgA antibodies to tTG are considered to have the highest predictive value, however, patients suffering from IgA deficiency, a frequent concomitant disease in celiac patients, demonstrate IgG autoantibodies to only tTG, hence apart from Gliadin IgG antibodies, IgG autoantibodies against tTG are the only serological parameter for the detection of celiac disease in such patients.

Product Specifications

Title Anti-hu tTG IgG
Product code 4044
Indication Celiac disease
Description Enzyme immunoassay for the quantitative determination of IgG antibodies against tissue transglutaminase in human serum
Format Microtiter plate coated with recombinant human tissue transglutaminase
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators + 2 x Controls

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.