TEST
CELIACHIA

AUTODIAGNOST

Description
Self-test for the determination of anti glyadine antibodies (anti-DGP), IgA and IgG, in blood for celiac screening.

Mode of use
1) Wash hands with hot water and soap, rinse with clean water and dry or use the cleaning gauze provided. Note: the use of hot water facilitates the withdrawal of capillary blood since it induces vasodilation.
2) Prepare the necessary material as follows: open the aluminum envelope, take only the cassette and throw away the drying bag. Open the plastic bag containing the pipette. Open the bottle by unscrewing the white cap, paying attention not to drop it.
3) Rotate 360° carefully the protective cap of the pointed hand without pulling it. Extract and eliminate the released cap.
4) Carefully massage the chosen falange for puncture (the side of the ring is recommended). It is important that the massage takes place from the palm of the hand to the falange, to improve the blood flow. Press the hand, on the side from which the cap was extracted, against the fingertip. The tip of the pointed hand is automatically portrayed safely after use. If the hand does not work properly, use the second hand. If the latter is not necessary, it can be disposed of without special precautions.
5) Keeping your hand turned down, massage your finger until a large drop of blood is formed. It is important that the massage takes place from the palm of the hand to the falange, to improve the blood flow.
6) Take the pipette without pressing the bulb Two withdrawal methods are suggested:
- hold the pipette horizontally without pressing the bulb and put it in contact with the drop of blood, it will enter independently for capillarity. Remove the pipette from the black line. If the blood is not enough, continue to massage your finger until you reach that line;
– put the pipette on a flat and clean surface by protruding the tip, at this point to contact the drop of blood with the pipette, it will enter independently for capillarity. Remove the finger from the black line. If the blood is not enough, continue to massage your finger until you reach that line. Avoid, as far as possible, interrupting contact between blood and pipette to prevent the formation of air bubbles.
7) Take the bottle previously opened and immediately deposit the blood collected with the pipette. Press the pipette bulb 2 or 3 times and make sure all the blood has dropped into the diluent solution. Then reposition the screw cap on the bottle and mix well for at least 10 seconds.
8) Avoid the blue cap from the dropper bottle (leave the tightly screwed white cap). Deposit 3 drops in the well indicated on the cassette (S).
9) Wait 10 minutes and interpret the results as below.
INTERPRETATION OF RESULTS
READ THE RESULT AFTER EXACTLY 10 MINUTES
The color intensity of the lines is of no importance for the interpretation of the test result.
NEGATIVE RESULTS
Only a coloured line appears under the sign C (Control). This result indicates that there are no anti-DGP antibodies in the blood or that their level is lower than the limit detected by the test.
POSITIVE RESULTS
Two colored lines appear in the reading window at T (Test) and C (Control). The intensity of the T line can be lower than the C line. The test must therefore be considered as positive regardless of the intensity of the test band T. This result indicates the presence of anti-DGP in the blood and therefore a probable Celiac disease. You need to consult your doctor to continue the diagnostic process.
NATIONAL RESULTS
Lines do not appear or appear only a line under sign T (Test) and not under sign C (Control). In this case it is not possible to interpret the result of the Test that must be considered invalid, it is recommended to carry out a new test.

Warnings
1. Read these instructions carefully for use before testing. The Test is reliable if the instructions are carefully respected.
2. Keep the Test away from the reach of children.
3. Do not use the Test after the expiry date or if the packaging is damaged.
4. Follow exactly the procedure respecting the indicated amounts of blood and diluent.
5. Don't freeze.
6. Use the Test and the tip only once.
7. The Test is only for external use. DON'T DELAY.
8. In vitro diagnostic device for individual use.
9. It is not recommended to use people who take medicines that make blood more fluid (anti-agulants) or people who have hemophilia problems.
10. After use, dispose of all the components according to current local standards, ask for advice to the pharmacist.

Conservation
Store Test components at temperature from +4°C to +30°C.
Validity of whole packaging: 24 months.

Format
Packaging:
- hermetically sealed aluminum envelope containing: 1 box of CELIAC TEST and 1 drying bag;
- sterile stinged hands for self-punture for blood sampling;
- dropper bottle containing CELIAC TEST thinner, sufficient for 1 test;
- plastic bag containing 1 pipette for blood sampling;
- alcohol cleaning gauze;
- 1 sheet of instructions for use.

Cod. MM-CEL