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 spectrum of symptoms such as diarrhea, abdominal distension, weight loss, malnutrition, and skin diseases. It is caused by a permanent intolerance to gluten, a complex of proteins found in wheat, barley, rye, many other cereals, and all foods containing them. In celiac subjects, gluten intolerance manifests with an immune response that involves the production of specific antibodies (IgA and IgG).
Xeliac® Test Pro is used as a support in the diagnosis of celiac disease, which must be confirmed by a physician. During a gluten-free diet, both the symptoms and the level 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 level is no longer detectable. Therefore, if you are following a gluten-free diet, it is possible to get a negative result. The application of a gluten-free diet should only be done under the instructions of a physician.

Instructions for use
XeliacR Test Pro is a simple, reliable, and rapid home self-test. A timer is required to perform XeliacR Test Pro. Perform the test in a well-lit area. The test requires only one drop (10 µl) of blood and can be read after 5 to 10 minutes from its execution. Sample collection is practically painless.
1. Remove the cassette from the aluminum 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 lancet (sterile) if the safety cap is missing or tampered with.
4. Gently massage a fingertip.
5. Place the lancet on the side of the fingertip (in the areas indicated in the figure) on the side where the safety cap was housed and press. The prick is practically painless. Caution: apply slight pressure to the fingertip before activating the lancet.
6. Immediately squeeze the fingertip until an abundant drop of blood appears. Take the pipette, bring it close to the blood drop until it touches it. The blood will automatically flow into the pipette up to the signal indicated on the nozzle (capillary filling). Do not press the bulb during this operation.
7. Once filled, squeeze the pipette, pressing on the bulb, into the hole of the cassette indicated by the arrow to empty it completely. If there is difficulty expelling all the blood, cover the ventilation hole on the nozzle with a finger.
8. Wait 60 seconds. In the meantime, apply the plaster to the fingertip.
9. Open the appropriate diluent nozzle (DIL) as described 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 the interpretation of the test may be difficult.
10. After performing this procedure, wait at least 5 minutes and then read the result. This result must appear within 10 minutes. After 10 minutes, the test is no longer reliable, whatever 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 must always appear. In this case, the presence of celiac disease can be practically excluded. In the presence of gastrointestinal symptoms, perform further medical investigations.
Positive result: near the blue transverse line, a red/pink one appears near the letter T (Test). This indicates a high probability of the existence of celiac disease. For a final diagnosis, consult your doctor.
Invalid result: if the blue Control line does not appear, the test is to be considered invalid, even if the red/pink line appears. In this case, it may be that the procedure was not performed correctly, that the reagents have deteriorated, or that an incorrect amount of blood was used. It is therefore necessary to repeat the test.
The test result is valid regardless of the intensity of the color of the lines.

Warnings
If the instructions for use are not correctly followed, the test result may be inaccurate. A final diagnosis must be made by a physician, based on clinical symptoms and further supporting laboratory analyses. Before starting a gluten-free diet, consult your doctor. Do not use the test after the expiration date. Do not use the test if the aluminum pouch is damaged. Handle all components with care. The diluent (DIL) contains Proclin 300. It may cause an allergic reaction, do not ingest. All components are single-use. Do not reuse any accessory. 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 falsely negative result only in limited cases such as low antibody titers. If the test result is contrary to expectations, consult your doctor. To dispose of used components, place them in the packaging and dispose of them as normal household waste. Keep Xeliac Test Pro out of the reach of children.

Storage
Store all test components at room temperature (+8° + 25° C). The product must be used by the date indicated on the label.

Components
Aluminum pouch containing: - Finger prick lancet (Dir. 93/42/EEC CE0459 Vitrex Medical A/S, Vasekaer 6-8. 2730 Herlev Denmark)
- Pipette for blood drop collection
- Single-dose diluent
- Plaster (Dir. 93/42/EEC - Class 1 - PromoCare B.V. Gerardus Gullaan 14 NL-1217 LN Hilversum - The Netherlands)

Cod. 9124