Prima Test Celiac Test has the function of checking the presence of specific antibodies against DGP, both IgA and IgG, within the blood, in order to verify a possible presence of celiac disease, which must be confirmed by a physician. Celiac disease, also known as “celiac sprue”, is an autoimmune disorder that involves the digestive process of the small intestine. It’s a chronic inflammatory disorder produced by the ingestion of dietary gluten products in susceptible people. It can have both environmental and hereditary factors: those who have celiac family members, in fact, are more likely to incur the disease during their lifetime. Celiac disease is defined as a permanent intolerance to gluten, a substance contained in wheat and composed of gliadin and glutenin. Gluten helps maintain food shape, acting like a glue that holds them together. Gliadin is the protein component of gluten, responsible for the immune system reaction, due to intestinal inflammation. In celiac subjects the immune system reacts against gluten damaging the intestinal wall, responsible for the absorption of nutrients. Cereals which contain gluten are: oats, wheat, barley, kamut, spelled, rye, spelled and triticale.Unlike common Celiac Disease Screening tests, which detect only the presence of IgA antibodies, the PRIMA® Lab Celiac Test identifies anti-DGP antibodies of both class A and G. This because many subjects have an IgA deficiency, often unknown, which could lead to false results if the parameter detected is only the immunoglobulin A. Celiac Test is based on an immunochromatographic reaction: if the antibodies IgA and IgG are present into the sample, they will react with the deamidated gliadin and a red band will appear in the test area. A positive result indicates that the antibody concentration is close to the determined cut-off. TECH SPECS CELIAC TEST is a lateral flow immunochromatographic device for the detection of IgA and IgG anti-DGP antibodies in whole blood. If antibodies are present in the sample, they will react with the deamidated gliadin. A positive result indicates that the antibody concentration is close to the cut-off of 20 U/mL. Specificity 94.1% Sensitivity 81.25% Accuracy 90.0% CONTENT 1 test cassette 1 vial with dropper containing the diluent 2 sterile lancets 1 pipette for blood sampling 1 cleanser gauze instructions for use USE PROCEDURE Draw a blood sample by using the sterile lancet provided; Collect the sample indicated with the black line by using the capillary pipette provided; Deposit the collected specimen into the vial, previously opened, then screw it; Add 3 drops of the obtained liquid into the sample well (S) indicated on the test cassette and wait 10 minutes before reading the result. RESULTS INTERPRETATION Negative no anti-DGP antibodies have been detected in the sample or their concentration is below the cut-off of 20 U/mL. Positive anti-DGP antibodies have been detected in the sample, thus a possible celiac disease. It is necessary to check with a specialist. BENEFIT: Test can be performed if you notice the typical symptoms related to a celiac condition A positive result indicates that the antibody concentration is close to the determined cut-off Results can be done at home, privately, quickly with results in just 10 minutes
