5014 – DotDiver CeliAK IgA

Highlights

• Detection of IgA antibodies against deamidated gliadin and tissue transglutaminase
• Supports the diagnosis of celiac disease in combination with clinical and laboratory findings
• Semi-automated use with the DotDiver instrument for standardized processing
• High diagnostic specificity and sensitivity for detecting celiac disease
• Ready-to-use test strips and cartridges for efficient workflow
• Reliable and reproducible results for routine laboratory testing
• Suitable for monitoring disease progression and gluten-related immune response
• CE marked
• Automatable

Intended Use

The DotDiver CeliAK IgA is a qualitative dot immunoassay for the determination of IgA antibodies against deamidated gliadin (d-gliadin) and tissue transglutaminase (tTG) in human serum. The DotDiver CeliAK IgA is intended as an aid in the diagnosis of celiac disease in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Detection of autoantibodies in patient samples is a cornerstone in the diagnosis and management of systemic autoimmune diseases. Autoantibodies directed against nuclear and cytoplasmic components serve as key biomarkers for disease identification and classification. For example, antibodies against double-stranded DNA (dsDNA) and nucleosomes are highly specific for systemic lupus erythematosus (SLE), while anti-Scl-70 and anti-PM/Scl antibodies are associated with systemic sclerosis and polymyositis-scleroderma overlap syndromes, respectively. Anti-SSA/Ro and anti-SSB/La antibodies are characteristic of Sjögren’s syndrome and may indicate an increased risk of extraglandular complications.

The detection of these antibodies not only assists in confirming diagnoses but also helps to stratify disease subtypes, monitor disease activity, and guide treatment decisions. Autoantibodies against ribosomal proteins, U1-snRNP, and histones are useful in identifying mixed connective tissue disease (MCTD) or drug-induced lupus. Anti-centromere antibodies (CENP-A/B) are predictive of limited systemic sclerosis, while antibodies against Jo-1, PCNA, M2, DFS-70, and f-Actin provide additional insights into rare or atypical autoimmune presentations. By enabling simultaneous screening of multiple antibody specificities, the ANA 18 LINE facilitates an integrated and efficient approach to autoimmune diagnostics, complementing clinical assessment and other laboratory tests.