Celiac disease

Description
Rapid immunochromatographic test for the detection of anti-DGP antibodies of both IgA and IgG class in whole blood for the screening of celiac disease.

How to use
1) Wash your hands with warm water and soap, rinse with clean water and dry or use the cleansing gauze provided. Note: the use of warm water facilitates the collection of capillary blood because it induces vasodilation.
2) Prepare the necessary material as follows: open the aluminum bag, take only the cassette and throw away the desiccant sachet. Open the plastic bag containing the pipette. Open the vial by unscrewing the white cap, being careful not to drop it.
3) Carefully rotate the protective cap of the lancet 360° without pulling it. Remove and discard the released cap.
4) Carefully massage the phalanx chosen for the puncture (the ring finger side is recommended). It is important to massage from the palm of the hand to the phalanx, to improve blood flow. Press the lancet, on the side from which the cap was removed, against the fingertip.
The lancet tip automatically retracts safely after use. If the lancet does not work properly, use the second one provided. If the second one is not needed, it can be disposed of without special precautions.
5) Keeping your hand facing down, massage your finger until a large drop of blood forms. It is important to massage from the palm of your hand to the knuckle, to improve blood flow.
6) Take the pipette without pressing the bulb. Two sampling methods are suggested:
– hold the pipette horizontally without pressing the bulb and put it in contact with the drop of blood, it will enter by capillarity. Move the pipette away when you reach the black line. If the blood is not enough, continue to massage your finger until you reach that line;
- place the pipette on a flat, clean surface, making sure the tip sticks out, then put the drop of blood in contact with the pipette, it will enter by itself by capillary action. Move your finger away when you reach the black line. If there is not enough blood, continue to massage your finger until you reach that line. Avoid, as much as possible, interrupting the contact between the blood and the pipette to prevent the formation of air bubbles.
7) Take the previously opened vial and immediately deposit the blood collected with the pipette inside. Press the bulb of the pipette 2 or 3 times and make sure that all the blood has fallen into the diluent solution. Then replace the screw cap on the vial and mix well for at least 10 seconds.
8) Unscrew the blue cap from the dropper bottle (leave the white cap tightly screwed on).
Place 3 drops in the well indicated on the cassette.
9) Wait 10 minutes and interpret the results.
Negative result: Only one colored line appears under the C (Control) mark. This result indicates that there are no anti-DGP antibodies in the blood or that their level is below the limit detectable by the test.
Positive result: two colored lines appear in the reading window corresponding to the T (Test) and C (Control) marks. The intensity of the T line may be lower than the C line. The test must therefore be considered positive regardless of the intensity of the T test band. This result indicates the presence of anti-DGP antibodies in the blood and therefore a probable Celiac disease. It is necessary to consult your doctor to continue the diagnostic process.
Invalid result: no lines appear or only one line appears under the T (Test) mark and not under the C (Control) mark. In this case, it is not possible to interpret the test result which must be considered invalid, it is recommended to perform a new test.

Warnings
1) Keep the test out of the reach of children.
2) Do not use the test after the expiry date shown on the package or if the package is damaged.
3) Follow the procedure exactly, respecting the indicated quantities of blood and diluent.
4) Do not freeze.
5) Use the test and the lancet only once.
6) The test is for external use only. Do not ingest.
7) In vitro diagnostic device for individual use.
8) Not recommended for use by people taking medicines that thin the blood (anticoagulants) or people who have haemophilia problems.
9) After use, dispose of all components in accordance with local regulations, ask your pharmacist for advice.

Conservation
Store test components at temperatures between +4°C and +30°C.

Format
Hermetically sealed protective aluminum pouch containing: 1 celiac test device and 1 desiccant sachet; 2 sterile lancets for self-pricking to draw blood; 1 dropper bottle containing celiac test diluent sufficient for 1 test; 1 plastic pouch containing 1 pipette for drawing blood; 1 antiseptic skin cleansing gauze and 1 instruction sheet for use.