8064 – CytoBead^® CeliAK

Highlights

• Slides coated with cryostat tissue sections of monkey esophagus and beads coated with tTG, deamidated gliadin (DG), and anti-human IgA
• Sensitive detection of IgA or IgG antibodies for celiac disease diagnosis
• Ready-to-use reagents (exception: PBS buffer)
• Quality assured handling in routine laboratories
• Short incubation times (30 min / 30 min) at room temperature
• Consistent processing for parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• Automated imaging using the AKLIDES® or akiron® systems
• CE marked

Intended Purpose

The CytoBead^® CeliAK is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgA or IgG antibodies in human serum against endomysium, tissue transglutaminase (tTG) and deamidated gliadin (DG) as well as for control of IgA antibodies. The CytoBead^® CeliAK 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 (CD), also known as gluten-sensitivity, damages the small intestine and leads to a so-called “flat” mucosa. These extensive lesions often cause malabsorption and deplete key nutrients. The immune system produces highly specific autoantibodies that target the common CD autoantigen tTG and antibodies against DG. EmA specifically recognize extracellular tTG. Except for DG antibodies, these antibodies are typically of the IgA class. In IgA deficient patients with celiac disease, the same type of antibodies in IgG class can be detected for diagnosis.

Publications

• Abdukhakimova et al., (2021) Harmonization of ANCA testing by reporting test result-specific likelihood ratios_position paper
• Sowa et al., (2017) Next-Generation Autoantibody Testing by Combination of Screening and Confirmation—the CytoBead® Technology
• Grossmann et al., (2016) Simultaneous detection of celiac disease-specific IgA antibodies and total IgA
• Sowa et al., (2014) Der CytoBead-Assay – Eine neue Möglichkeit der multiparametrischen AutoAbsanalytik bei systemischen Autoimmunerkrankungen