It's a rapid immunoassay for detection of anti-gliadin antibodies and IgA against human tissue transglutaminase (tTG), the main autoantigen recognized by anti-endomysial antibodies, in whole blood samples.
The NADAL® Celiac Disease tTG & Gliadine Test is designed for professional use only and is especially useful in the case of pediatric patients (up to 16 years old).
Reagents and material supplied:
10 NADAL® Celiac Disease tTG & Gliadine test cassettes
10 Sterile lancets
10 Collection pipettes (20 μl)
1 Dilution buffer (3 mL)
1 package insert
Test time: 10 min
Performance characteristics:
Specificity and sensitivity of the NADAL® Celiac Disease tTG & Gliadine Test considering anti-tTG IgA and anti-gliadin antibodies is assesed by comparison with: Eurospital Eu-tTG IgA; Gliatest S IgA Chromo tests and conventional ELISA assay.
Performance characteristics in comparison to Eurospital Eu-tTG IgA; Gliatest S IgA Chromo
Anti-tTG IgA
Sensitivity concordance: 86.7%
Specificity concordance: 95.3%
Concordance: 93.6%
Under 16 years old:
Sensitivity concordance: 90%
Specificity concordance: 92%
Concordance: 91.3%
Anti-gliadin antibodies:
Sensitivity concordance: 30%
Specificity concordance: 97%
Concordance: 88.5%
Under 16 years old:
Sensitivity concordance: 50%
Specificity concordance: 98.8%
Concordance: 93%
Performance characteristics according to conventional ELISA assays:
Concordance for patients with Celiac Disease: 67%
Concordance for control patients: 56%
No Hook effect was observed was observed for any positive sample tested.
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