Home Celiac Disease Test
CE medical device, home celiac disease test.
Determines the presence of class A and class G anti-transglutaminase antibodies associated with celiac disease in a human blood sample.
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 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 level is no longer detectable. Therefore, if you are following 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.
Directions for use
A timer is required to perform the test.
Perform the test in a well-lit place.
The test requires only 1 drop (10 µl) of blood and can be performed and read in approximately 5 - 10 minutes.
Sample collection is virtually painless.
Before performing the test, arrange the components in an accessible manner.
Remove the cassette from the aluminum pouch and place it on a dry, horizontal surface.
The test must be performed within 10 minutes.
1. Prepare the plastic pipette and place it in an easily accessible position.
2. Take the lancet. Twist the gray cap several times to make it click and remove it completely. Never press the button during this operation.
3. Gently massage a fingertip and then clean it with the disinfectant wipe. Let the finger dry.
4. Place the sterile lancet on the side of the fingertip where the gray cap was located and press the button. The puncture is practically painless.
5. Squeeze the fingertip until a drop of blood appears. Take the pipette, bring it close to the drop of blood until it touches it, and use it to collect the blood up to the mark indicated on the nozzle. Filling occurs by capillary action. Do not press the bulb during this operation.
6. 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 nozzle with your finger.
7. Wait 60 seconds.
8. Open the single-dose container marked DIL and dispense 3 drops of the contents into the same hole where the pipette was previously emptied.
9. After completing this procedure, wait at least 5 minutes and then read the result. As soon as 1 blue line appears in the central hole, the test is considered to have been performed correctly. If 1 red line also appears on the other side of the central hole, the result is considered positive. This result must appear within 10 minutes. After these 10 minutes, the test is no longer valid. reliable, whatever the result.
Test Components
- Cassette with test stick in aluminum pouch;
- sterile lancet for fingerstick UNISTIK 3;
- pipette for blood collection;
- single-dose containing diluent;
- disinfectant wipe;
- plaster.
The test result is Positive if 1 blue line and 1 red line appear in the central hole of the cassette.
The test result is Negative if only one blue line appears in the central hole. If the blue control line does not appear, it is likely that you did not follow the instructions correctly. In this case, repeat the procedure using a new test.
Positive: the test indicates the presence of IgA and IgG antibodies associated with celiac disease in the blood sample. In the case of an IgA deficiency, it indicates the presence of IgG. This has no impact on the color of the line. The presence of at least one of these two antibodies highly likely indicates the presence of celiac disease. For a final diagnosis, consult your doctor.
Negative: The test indicates that there are no IgA and/or IgG antibodies associated with celiac disease in the blood sample detectable by the test. The presence of celiac disease can be virtually ruled out. If gastrointestinal symptoms occur, further medical investigations should be performed. Caution: If the amount of blood was drawn incorrectly or the blood sample was not dispensed correctly, the test may give incorrect results.
Warnings
1. If the instructions for use are not correctly followed, the test result may be distorted.
2. A final diagnosis must be made by a physician based on clinical symptoms and additional supporting laboratory tests.
3. Consult your physician before starting a gluten-free diet.
4. Do not use the test after the expiration date.
5. Do not use the test if the foil pouch is damaged. Do not use damaged accessories.
6. The sample diluent contains Proclin 300 at a concentration of 0.01%. Do not ingest.
7. Xeliac Test Pro is very reliable (92% sensitivity). 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.
8. All components are intended for single use only. Do not reuse any accessories.
9. To dispose of used components, place them in the packaging and dispose of them as normal household waste.
10. Keep Xeliac Test Pro out of the reach of children.
CE mark registration number
0123.
Product Code:FRCM007251
Price Trend
This product has been on sale since 25/09/2017
In the last 30 days, the product's lowest price
was 17,5 €
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