NADAL Campylobacter

General information about this test: The NADAL Celiac Disease (tTG) Test is a rapid immunoassay for detection of IgA/IgG/IgM antibodies against human tissue transglutaminase (tTG), the main autoantigen recognized by anti-endomysial antibodies, in whole blood or serum. samples. The NADAL Celiac Disease (tTG) Test is designed for professional use only. Reagents and material supplied : 10 NADAL Celiac Disease (tTG) test cassettes 10 Sterile lancets 10 Collection pipettes (20 μl) 1 Dilution buffer (3 mL) 1 package insert Test time : 10 min Performance characteristics : The NADAL Celiac Disease (tTG) Test do not show cross reactivity with the following substances: Aspirin (50 mg/mL), Caffeine (10 mg/mL), Ibuprofen (8 mg/mL), Ethanol (500 mg/mL), Folic acid (0,4 mg/mL), Nicotinic acid (20 mg/mL), Haemoglobin (15 mg/mL), hCG (250000 mUI/ml), EDTA (20 mg/ml), Sodium citrate (0,2 M), Heparin (500 mg/ml) Specificity and sensitivity of the NADAL Celiac Disease (tTG) Test were determined by comparison with: ELISA/EIA, EliA-ImmunoCAP 100 (Phadia) Test, Alphadia Immunodot Gliadin-tTG Dot test kit and organized by Eurospital and carried out in a bench-mark CD hospital in Italy. Characteristics in comparison to ELISA/EIA: Sensitivity: 89% Specificity: 92.5% Efficacy: 89.3% Characteristics in comparison to EliA-ImmunoCAP 100 (Phadia) Test: NADAL Celiac Disease (tTG) Test is highly useful for possible CD screening programs. Performance characteristics in comparison to Alphadia Immunodot Gliadin-tTG Dot test kit: Sensitivity concordance: >99% Specificity concordance: 98.9% Concordance percent: 99% Performance characteristics as assessed in comparison to results obtained during a Sensitivity: 94.4% Specificity: 100% Positive Predictive Value: 100% Negative Predictive Value: 96.9% No Hook effect was observed was observed for any positive sample tested. Test principles : The NADAL Celiac Disease (tTG)Test is a rapid immunochromatographic assay for detection of IgA/IgG/IgM antibodies against human tissue transglutaminase (tTG) in blood or serum. In case of positive result, during testing the anti-tTG antibodies bind to latex particles conjugated with human recombinant tTG, forming a complex which migrates along the test strip and reaches the reaction area of the test. There it reacts with recombinant human tTG, 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, 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.