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Xeliac Test Pro Detects the presence of class A and class G anti-transglutaminase antibodies associated with celiac disease in a human blood sample. Celiac disease is a serious, lifelong gastrointestinal disorder that can cause a wide range of symptoms, including diarrhea, abdominal distention, weight loss, malnutrition, and skin conditions. It is caused by a lifelong intolerance to gluten, a complex of proteins found in wheat, barley, rye, many other grains, and all foods containing them. In celiac patients, gluten intolerance manifests itself with an immune response that involves the production of specific antibodies (IgA and IgG). Xeliac® Test Pro is used to aid in the diagnosis of celiac disease, which must be confirmed by a doctor. While following a gluten-free diet, both the symptoms and the levels of IgA and IgG antibodies associated with celiac disease decrease. Often, a few weeks after changing the diet, or at the latest within 6 weeks, the antibody levels are no longer detectable. Therefore, if you are following a gluten-free diet, you may receive a negative result. Adoption of a gluten-free diet should be done only under the direction of a doctor. How to use XeliacR Test Pro is a simple, reliable, and rapid home self-test. To perform XeliacR Test Pro, you need a timer. Perform the test in a well-lit area. The test requires only one drop (10 fL) of blood and can be read 5 to 10 minutes after completion. Sample collection is virtually painless. 1. Remove the cassette from the foil pouch and place it on a dry, horizontal surface. The test must be performed within 10 minutes. 2. Prepare the plastic pipette and place it in an easily accessible position. 3. Take the lancet. Twist the safety cap and remove it completely. The lancet is ready for use. Do not use the sterile lancing device if the safety cap is missing or tampered with. 4. Gently massage a fingertip. 5. Place the lancing device on the side of your fingertip (in the areas shown in the figure) where the safety cap was located and press down. The puncture is virtually painless. Caution: Apply light pressure to the fingertip before operating the lancet. 6. Immediately squeeze your fingertip until a large drop of blood appears. Take the pipette and bring it close to the drop of blood until it touches it. The blood will automatically flow into the pipette until it reaches the mark on the tip (capillary filling). Do not squeeze the bulb during this operation. 7. Once filled, squeeze the pipette, pressing on the bulb, into the hole in the cassette indicated by the arrow to empty it completely. If you have difficulty expelling all the blood, cover the ventilation hole on the spout with your finger. 8. Wait 60 seconds. Meanwhile, apply the patch to your fingertip. 9. Open the diluent nozzle (DIL) as indicated by the arrows and dispense 4 drops into the same hole where the pipette was previously emptied. Caution: Do not dispense more than 4 drops of diluent, otherwise test interpretation may be difficult. 10. After completing this procedure, wait at least 5 minutes and then read the result. The result should appear within 10 minutes. After 10 minutes, the test is no longer reliable, regardless of the result. 11. Interpretation of results. Negative result: Only a blue transverse line appears near the letter C on the cassette. This line is the Control line and should always appear. In this case, celiac disease can be virtually ruled out. If gastrointestinal symptoms occur, further medical investigations should be performed. Positive result: A red/pink line appears next to the letter T (Test) next to the blue transverse line. This highly likely indicates celiac disease. For a final diagnosis, contact your doctor. Invalid result: If the blue Control line does not appear, the test is considered invalid, even if the red/pink line appears. In this case, the procedure may not have been performed correctly, the reagents may have deteriorated, or the wrong amount of blood was added. The test must therefore be repeated. The test result is valid regardless of the color intensity of the lines. Warnings Failure to follow the instructions for use may result in false test results. A final diagnosis must be made by a physician based on clinical symptoms and additional supporting laboratory tests. Consult your physician before starting a gluten-free diet. Do not use the test after the expiration date. Do not use the test if the foil pouch is damaged. Handle all components with care. The diluent (DIL) contains Proclin 300. May cause an allergic reaction; do not ingest. All components are for single use only. Do not reuse any accessories. Xeliac Test Pro has a sensitivity of 96.5% and a specificity of 97.3%. Alcohol or local anesthetics do not alter the test. The test may give a false negative result only in limited cases, such as low antibody titers. If the test result is contrary to expectations, consult your physician. To dispose of used components, return them to the packaging and dispose of them as normal household waste. Keep Xeliac Test Pro out of the reach of children. Conservation Store all test components at room temperature (8°C to 25°C). The product must be used by the expiration date indicated on the label. Components Aluminum sachet containing: - Finger prick for blood sampling (Dir. 93/42/EEC CE0459 Vitrex Medical A/S, Vasekaer 6-8. 2730 Herlev Denmark) - Pipette for blood collection - Diluent in single-dose packaging - Patch (Dir. 93/42/EEC - Class 1 - PromoCare BV Gerardus Gullaan 14 NL-1217 LN Hilversum - The Netherlands) Cod. 9124
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