4033 – Anti-huTransG

Highlights

• Use of purified tissue transglutaminase (tTG) as target antigen
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times (60 min / 30 min / 15 min) at room temperature
• Quantitative determination of IgA antibodies
• Excellent diagnostic sensitivity and specificity shortly after onset of the disease
• Results expressed in IU/mL
• High precision and linearity within the measurement range
• CE marked
• For manual professional in-vitro use

Intended Purpose

The Anti-huTransG is a quantitative immunoassay for the determination of IgA antibodies against tissue transglutaminase (tTG) in human serum. The Anti-huTransG is intended as an aid in the diagnosis of 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 this extensive lesions, malabsorption occurs frequently accompanied with a depletion of key nutrients. Dermatitis herpetiformis, an autoimmune chronic relapsing skin disease, demonstrates celiac-like changes in the intestine, resembling the inflammatory process in celiac patients. This disease forms sub-epidermal blisters, and IgA antibodies reside in the basal membrane, associated with neutrophil and eosinophil infiltration.

Diagnosis of celiac disease and dermatitis herpetiformis comprises small intestine biopsy demonstrating a “flat” mucosa prior to a gluten-free diet and the following 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.

Publications

• Grossmann et al., (2016) Simultaneous detection of celiac disease-specific IgA antibodies and total IgA
• Conrad et al., (2012) A new dot immunoassay for simultaneous detection of celiac specific antibodies and IgA-deficiency