NADAL C. difficile GDH Ag

General information about this test : The NADAL Celiac Disease tTG & Gliadine Test is 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. Test principle : The NADAL Celiac Disease tTG & Gliadine Test is a rapid immunochromatographic assay for detection of anti-gliadin antibodies and IgA antibodies against human tissue transglutaminase (tTG) in blood. In case of positive result, during testing the anti-tTG antibodies (and anti-gliadin antibodies among them) bind to latex particles conjugated with anti-IgA antibodies, forming complexes (colloidal particles/anti-IgA antibodies/anti-tTG IgA and colloidal particles/anti-IgA antibodies/anti-gliadin IgA complexes) which migrate along the test strip and reach the reaction area of the test. There they react with recombinant human tTG and wheat gliadin, which leads to the formation of a red line in the test region (T) of the cassette. A blue line should always appear in the control (C) line region of the test cassette. This is internal procedural control, indicating that enough sample has been used and that the assay was run properly. Clinical significance : Celiac Disease (CD) is an autommune enteropathy caused by permanent intolerance to gluten (especially to one of its fractions - gliadin), a protein found in products containing rye, barley or wheat. In patient genetically predisposed to CD, regular consumption of such products can lead to occurrence of cause serious lesions of the intestinal mucosa. The most common symptoms of CD include chrnonic diarrhea, abdominal destention, malabsorption, loss of apetite and growth failure in children. Symptoms may vary and may be absent esepcially in patients older than 2 years. Although it is usually found in young age (6 months – 2 years) CD can be diagnosed at any age. It has been associated with other autoimmune diseases such as diabete mellitus type 1, thyroiditis, etc. Celiac Disease is diagnosed on the basis of histological alteration (crypt hyperplasia with complete or incomplete atrophy of intestinal villi) observed in intestinal biopsies. Immunological assays for detection of circulating anti-gliadin, anti-tTG and anti-endomysial antibodies is specific, cheaper and less invasive approach for diagnosis of CD.