Descrizione Clinica
Diagnostics - Xeliac diagnostics test pro iga igg 1pz
Xeliac Test Pro
It detects the presence of class A and class G anti-transglutaminese antibodies associated with celiac disease present in a human blood sample.
Celiac disease is a serious gastrointestinal disorder that lasts all life and can cause a wide spectrum of symptoms such as: diarrhea, abdominal distension, weight loss, malnutrition, skin diseases. It is due to a permanent intolerance to gluten, a protein complex found in wheat, barley, rye, many other cereals and all the foods that contain them. In celiac subjects gluten intolerance is manifested 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 doctor. During a gluten-free diet, both symptoms and 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 level of antibodies is no longer decisive. Therefore if you are following a gluten-free diet you can get a negative result. The application of a gluten-free diet should only take place according to the instructions of a doctor.
Mode of use
XeliacR Test Pro and a simple, reliable and fast home automation test. To perform XeliacR Test Pro an accountant is required. Test in a well-lit place. The test requires only one drop (10 fÄ°l) of blood, and can be read after 5 until 10 minutes from its execution. Sample picking and practically painless.
1. Extract the cassette from the aluminum sachet and place it on a dry horizontal surface. The test must be carried out within 10 minutes.
2. Prepare the plastic pipette and place it in an easily accessible position.
3. Take the stinged hand. Rotate the safety cap and extract it completely. The pointed hand is ready for use. Do not use the sting (sterile) if the safety cap is absent or tampered with.
4. Massage a fingertip gently.
5. Support on the side of the fingertip (in the areas indicated in the figure on the side) the stinged from the side where it stayed the safety cap and crush. Puncture is practically painless. Caution: exert a slight pressure on the fingertip before activating the pointed hand.
6. Fasten the fingertips immediately until a large drop of blood appears. Take the pipette, approach the drop of blood to touch it. The blood will flow automatically into the pipette until the signal indicated on the spout (filling for capillarity). Do not press the bulb during this operation.
7. Once filled, squeeze the pipette, pressing on the bulb, in the hole of the cassette indicated by the arrow so as to empty it completely. In case there were difficulties to expel all the blood, stop with a finger the ventilation hole present on the spout.
8. Wait 60 seconds. In the meantime apply the patch on the fingertips.
9. Open the special diluent spout (DIL) as described by the arrows and dispense 4 drops in the same hole where the pipette was first emptied. Attention: Do not dispense more than 4 drops of diluent, otherwise the interpretation of the test may be difficult.
10. Run 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 transversal 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 additional medical investigations.
Positive result: near the blue cross line there is a red/pink near the letter T (Test). This indicates with high probability the existence of celiac disease. For a final diagnosis, please contact your doctor.
Result not valid: if the blue line of Control does not appear, the test should be considered invalid, even if the red/pink line appears. In this case it may be that the procedure has not been performed correctly, that the reagents have deteriorated or that an incorrect amount of blood has been placed. It is therefore necessary to repeat the test.
The test result is valid whatever the color intensity of the lines.
Warnings
If the instructions for use are not properly observed, the outcome of the test can be false. A final diagnosis must be performed by a doctor, based on clinical symptoms and further laboratory analysis to support. Before starting a gluten-free diet consult your doctor. Do not use the test after the expiry date. Do not use the test if the aluminum bag is damaged. Carefully handle all components. The diluent (DIL) contains Proclin 300. It can cause allergic reaction, do not ingest. All components are disposable. Do not reuse any accessories. Xeliac Test Pro has a sensitivity of 96.5% and a specificity of 97.3%. Local alcohol or anesthetics do not alter the test. The test can give a falsely negative result only in limited cases such as low antibody titles. If the test result is contracted to expectations, consult your doctor. To remove the components used insert them into the packaging and dispose of them as normal household waste. Keep Xeliac Test Pro out of 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 bag containing: - Withdraw (Dir. 93/42/EEC CE0459 Vitrex Medical A/S, Vasekaer 6-8. 2730 Herlev Denmark)
- Blood drop pipette
- Diluent in monodose packaging
- Cerotto (Dir. 93/42/EEC - Class 1 - PromoCare B.V. Gerardus Gullaan 14 NL-1217 LN Hilversum - The Netherlands
Cod. 9124
Celiac disease is a serious gastrointestinal disorder that lasts all life and can cause a wide spectrum of symptoms such as: diarrhea, abdominal distension, weight loss, malnutrition, skin diseases. It is due to a permanent intolerance to gluten, a protein complex found in wheat, barley, rye, many other cereals and all the foods that contain them. In celiac subjects gluten intolerance is manifested 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 doctor. During a gluten-free diet, both symptoms and 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 level of antibodies is no longer decisive. Therefore if you are following a gluten-free diet you can get a negative result. The application of a gluten-free diet should only take place according to the instructions of a doctor.
Mode of use
XeliacR Test Pro and a simple, reliable and fast home automation test. To perform XeliacR Test Pro an accountant is required. Test in a well-lit place. The test requires only one drop (10 fÄ°l) of blood, and can be read after 5 until 10 minutes from its execution. Sample picking and practically painless.
1. Extract the cassette from the aluminum sachet and place it on a dry horizontal surface. The test must be carried out within 10 minutes.
2. Prepare the plastic pipette and place it in an easily accessible position.
3. Take the stinged hand. Rotate the safety cap and extract it completely. The pointed hand is ready for use. Do not use the sting (sterile) if the safety cap is absent or tampered with.
4. Massage a fingertip gently.
5. Support on the side of the fingertip (in the areas indicated in the figure on the side) the stinged from the side where it stayed the safety cap and crush. Puncture is practically painless. Caution: exert a slight pressure on the fingertip before activating the pointed hand.
6. Fasten the fingertips immediately until a large drop of blood appears. Take the pipette, approach the drop of blood to touch it. The blood will flow automatically into the pipette until the signal indicated on the spout (filling for capillarity). Do not press the bulb during this operation.
7. Once filled, squeeze the pipette, pressing on the bulb, in the hole of the cassette indicated by the arrow so as to empty it completely. In case there were difficulties to expel all the blood, stop with a finger the ventilation hole present on the spout.
8. Wait 60 seconds. In the meantime apply the patch on the fingertips.
9. Open the special diluent spout (DIL) as described by the arrows and dispense 4 drops in the same hole where the pipette was first emptied. Attention: Do not dispense more than 4 drops of diluent, otherwise the interpretation of the test may be difficult.
10. Run 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 transversal 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 additional medical investigations.
Positive result: near the blue cross line there is a red/pink near the letter T (Test). This indicates with high probability the existence of celiac disease. For a final diagnosis, please contact your doctor.
Result not valid: if the blue line of Control does not appear, the test should be considered invalid, even if the red/pink line appears. In this case it may be that the procedure has not been performed correctly, that the reagents have deteriorated or that an incorrect amount of blood has been placed. It is therefore necessary to repeat the test.
The test result is valid whatever the color intensity of the lines.
Warnings
If the instructions for use are not properly observed, the outcome of the test can be false. A final diagnosis must be performed by a doctor, based on clinical symptoms and further laboratory analysis to support. Before starting a gluten-free diet consult your doctor. Do not use the test after the expiry date. Do not use the test if the aluminum bag is damaged. Carefully handle all components. The diluent (DIL) contains Proclin 300. It can cause allergic reaction, do not ingest. All components are disposable. Do not reuse any accessories. Xeliac Test Pro has a sensitivity of 96.5% and a specificity of 97.3%. Local alcohol or anesthetics do not alter the test. The test can give a falsely negative result only in limited cases such as low antibody titles. If the test result is contracted to expectations, consult your doctor. To remove the components used insert them into the packaging and dispose of them as normal household waste. Keep Xeliac Test Pro out of 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 bag containing: - Withdraw (Dir. 93/42/EEC CE0459 Vitrex Medical A/S, Vasekaer 6-8. 2730 Herlev Denmark)
- Blood drop pipette
- Diluent in monodose packaging
- Cerotto (Dir. 93/42/EEC - Class 1 - PromoCare B.V. Gerardus Gullaan 14 NL-1217 LN Hilversum - The Netherlands
Cod. 9124
