PRIMA Celiac (Celiac Disease) Home Test Self-test for the detection of antibodies against deamidated gliadin (anti-DGP), IgA and IgG, in the blood for screening for celiac disease Contents: 1 test Celiac disease and anti-DGP antibodies Celiac disease is a chronic autoimmune disease in which the small intestine becomes inflamed due to the ingestion of gliadin: gliadin is the protein component of gluten, which is found in various grains (oats, wheat, barley, kamut, spelt, rye, and triticale). Gliadin is a water-soluble peptide component that acts as a glue, helping to maintain the shape of food and allowing it to pass through the intestinal epithelium. Recent studies have shown that, due to the action of transglutaminase, celiac patients produce specific antibodies against gliadin-deamidated peptides (anti-DGP), IgA and IgG, which exhibit high specificity and sensitivity for celiac disease and allow for highly accurate disease screening. WHO IS THE TEST FOR? The CELIAC TEST is useful for anyone who wants to test for a possible gluten intolerance, which then needs to be confirmed by a doctor. It is particularly useful for individuals with symptoms suggestive of celiac disease, such as abdominal pain and swelling, chronic diarrhea, constipation, vomiting, weight loss, and irritability, or for those with a genetic predisposition to the disease. Even in the absence of the above symptoms, the test is helpful in case of a deficiency in iron, vitamin B, or folic acid, which could indicate an inadequate intake of essential nutrients. TECHNICAL DATA The CELIAC TEST is an immunochromatographic lateral flow instrument for the detection of IgA and IgG class anti-DGP antibodies in whole blood. If antibodies are present in the sample, they react with the deamidated gliadin. A positive result indicates that the antibody concentration is close to the cutoff value of 20 U/mL. Specificity 94.1% Sensitivity 81.25% Accuracy 90.0% CONTENTS - 1 test cassette - 1 dropper bottle containing the thinner - 2 sterile lancets - 1 pipette for blood collection - 1 antiseptic cleaning gauze - Instructions for use MISSION 1. Take a blood sample using the supplied sterile lancet; 2. Take the sample marked by the black line using the supplied capillary pipette; 3. Place the collected sample into the previously opened dropper bottle containing the buffer and screw it back on tightly; 4. Place 3 drops of the liquid obtained in this way into the well (S) indicated on the cassette and wait 10 minutes to read the result. INTERPRETATION OF THE RESULTS Negative: No anti-DGP antibodies were detected in the sample, or their concentration is below the limit of 20 U/mL. Positive: Anti-DGP antibodies were detected in the sample, suggesting a possible case of celiac disease. A medical examination is necessary. QUESTIONS & ANSWERS: What happens if the times for reading the results are not adhered to? The test was performed correctly if the instructions for use were followed, including the reading time and the interpretation of the results as specified in the INTERPRETATION OF RESULTS section of the instructions for use. How can you verify if the test worked correctly? A colored line appears in the control area (C) of the test device, indicating that the test has been performed correctly. If this line is not present, the test should be repeated with a new device and a new sample. How should the test be interpreted if the control and test lines show different intensities? The color and intensity of the lines are not important for interpreting the result. The test is considered positive regardless of the intensity of the test line color (T).