Description
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 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 that contain 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 as an aid in the diagnosis of celiac disease, which must be confirmed by a doctor. 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 on a gluten-free diet, you may get a negative result. The application of a gluten-free diet should only be done according to the instructions 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 place. The test requires only one drop (10 fÊl) of blood, and can be read 5 to 10 minutes after its execution. Taking the sample is practically 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 lancet (sterile) if the safety cap is missing or tampered with.
4. Gently massage a fingertip.
5. Place the lancing device on the side of the fingertip (in the areas indicated in the figure on the side) on the side where the safety cap was located and press. The puncture is practically painless. Caution: apply light pressure on the fingertip before activating 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 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 in order to empty it completely. If there is difficulty in expelling all the blood, cover the ventilation hole on the spout with a finger.
8. Wait 60 seconds. In the meantime, apply the patch to the fingertip.
9. Open the diluent nozzle (DIL) as shown 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 one transverse light blue line appears near the letter C on the cassette. This line is the Control line and should always appear. In this case, the presence of celiac disease can be practically excluded. If gastrointestinal symptoms occur, further medical investigations should be performed.
Positive result: next to the blue transverse line, a red/pink one appears next to the letter T (Test). This indicates with high probability the existence of 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, it may be that the procedure was not performed correctly, that the reagents have deteriorated or that an incorrect 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
If the instructions for use are not followed correctly, the test result may be falsified. A final diagnosis must be made by a doctor, based on clinical symptoms and additional supporting laboratory tests. Consult your doctor before starting a gluten-free diet. Do not use the test after the expiry 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 doctor. To dispose of used components, put them back in 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° + 25° C). The product must be used by the date indicated on the label.
Components
Aluminum pouch containing: - Finger prick for blood collection (Dir. 93/42/EEC CE0459 Vitrex Medical A/S, Vasekaer 6-8. 2730 Herlev Denmark)
- Pipette for blood drop sampling
- Diluent in single-dose packaging
- Patch (Dir. 93/42/EEC - Class 1 - PromoCare BV Gerardus Gullaan 14 NL-1217 LN Hilversum - The Netherlands)
Code 9124
Celiac disease is a serious, lifelong gastrointestinal disorder that can cause a wide range 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 that contain 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 as an aid in the diagnosis of celiac disease, which must be confirmed by a doctor. 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 on a gluten-free diet, you may get a negative result. The application of a gluten-free diet should only be done according to the instructions 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 place. The test requires only one drop (10 fÊl) of blood, and can be read 5 to 10 minutes after its execution. Taking the sample is practically 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 lancet (sterile) if the safety cap is missing or tampered with.
4. Gently massage a fingertip.
5. Place the lancing device on the side of the fingertip (in the areas indicated in the figure on the side) on the side where the safety cap was located and press. The puncture is practically painless. Caution: apply light pressure on the fingertip before activating 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 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 in order to empty it completely. If there is difficulty in expelling all the blood, cover the ventilation hole on the spout with a finger.
8. Wait 60 seconds. In the meantime, apply the patch to the fingertip.
9. Open the diluent nozzle (DIL) as shown 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 one transverse light blue line appears near the letter C on the cassette. This line is the Control line and should always appear. In this case, the presence of celiac disease can be practically excluded. If gastrointestinal symptoms occur, further medical investigations should be performed.
Positive result: next to the blue transverse line, a red/pink one appears next to the letter T (Test). This indicates with high probability the existence of 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, it may be that the procedure was not performed correctly, that the reagents have deteriorated or that an incorrect 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
If the instructions for use are not followed correctly, the test result may be falsified. A final diagnosis must be made by a doctor, based on clinical symptoms and additional supporting laboratory tests. Consult your doctor before starting a gluten-free diet. Do not use the test after the expiry 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 doctor. To dispose of used components, put them back in 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° + 25° C). The product must be used by the date indicated on the label.
Components
Aluminum pouch containing: - Finger prick for blood collection (Dir. 93/42/EEC CE0459 Vitrex Medical A/S, Vasekaer 6-8. 2730 Herlev Denmark)
- Pipette for blood drop sampling
- Diluent in single-dose packaging
- Patch (Dir. 93/42/EEC - Class 1 - PromoCare BV Gerardus Gullaan 14 NL-1217 LN Hilversum - The Netherlands)
Code 9124
