Xeliac Test

CELIAC DIAGNOSIS TEST

Indications:
home celiac disease test.
Determines the presence of class A and class G anti-transglutaminase associated with celiac disease present 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 level of IgA and IgG antibodies associated with celiac disease decrease. Often, a few weeks after changing your diet, or within 6 weeks at the latest, the antibody level is no longer determinable, so if you are on a gluten-free diet you may get a negative result. Applying a gluten-free diet should only be based on a doctor's instructions.

How to use:
a timer is required to perform the test.
Carry out the test in a well-lit place.
The test requires only 1 drop (10 µl) of blood, can be performed and read for approximately 5-10 minutes.
The sampling is practically painless.
Arrange the components in an accessible manner before running the test.
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. Turn the gray cap several times so that it clicks and pull it out completely. During this operation, never press the button.
3. Gently massage a fingertip and then clean it with the disinfectant wipe. Let your finger dry.
4. Place the sterile lancet on the side of the fingertip on the side 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 with it collect the blood up to the signal indicated on the spout. The filling takes place by capillarity. 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 in order to empty it completely. If you find it difficult to expel all the blood, plug the vent hole on the spout with your finger.
7. Wait 60 seconds.
8. Open the single dose marked DIL and dispense 3 drops of the contents into the same hole where the pipette was previously emptied.
9. After 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 to be considered correctly performed. If there is also 1 red line on the other side of the central hole, the result is to be considered positive. This result must appear within 10 minutes. After these 10 minutes the test is no longer reliable, whatever the result.

Characteristics:
test components:
- cassette with reactive stick in aluminum sachet;
- UNISTIK 3 sterile lancet for sampling;
- pipette for blood drop sampling;
- single-dose containing diluent;
- disinfectant wipe;
- bandaid.
The test result is Positive if 1 blue line and a red line appear in the center hole of the cassette.
The test result is Negative if only one blue line appears in the center hole. If the blue control line does not appear, it is likely that you have not followed 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 signals the presence of IgG. This has no implications for the color of the line. The presence of at least one of these two antibodies indicates with a high probability the existence of celiac disease. For a final diagnosis, contact your doctor.
Negative: The test indicates that there are no IgA and / or IgG class antibodies associated with celiac disease in the blood sample detectable by the test. The presence of celiac disease can be virtually excluded. If gastrointestinal symptoms are present, further medical investigation should be performed. Attention, if the quantity of blood has been drawn incorrectly or the blood sample has not been dispensed correctly, the test may give incorrect results.

Warnings:
1. If the instructions for use are not properly observed, the test result may be falsified.
2. A final diagnosis should be made by a physician, based on clinical symptoms and additional supporting laboratory tests.
3. Before starting a gluten-free diet consult your doctor.
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 in a concentration of 0.01%. Do not swallow.
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 doctor.
8. All components are intended for single use only. Do not reuse any accessories.
9. To dispose of used components, place them in the package and dispose of them as normal household waste.
10. Keep Xeliac Test Pro out of the reach of children.

Cod. 9124