Mytest Celiac Disease Kit

Celiac Disease

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

Method of use
1) Wash hands with warm water and soap, rinse with clean water and dry or use the provided cleaning gauze. Note: the use of warm water facilitates capillary blood sampling as it induces vasodilation.
2) Prepare the necessary materials as follows: open the aluminum bag, take only the cassette and discard the desiccant sachet. Open the plastic bag containing the pipette. Open the vial by unscrewing the white cap, being careful not to let it fall.
3) Carefully rotate the protective cap of the lancet 360° without pulling it. Remove and discard the released cap.
4) Gently massage the chosen finger for the puncture (the side of the ring finger is recommended). It is important that the massage goes from the palm to the fingertip to improve blood flow. Press the lancet from which the cap was removed against the fingertip.
The tip of the lancet retracts automatically and safely after use. If the lancet does not work properly, use the second one provided. If the second is not needed, it can be discarded without special precautions.
5) Keep your hand facing downward, massage the finger until a large drop of blood forms. It is important that the massage goes from the palm to the fingertip 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 bring it into contact with the blood drop, which will enter automatically by capillarity. Move the pipette away when reaching the black line. If the blood is not enough, continue massaging the finger until reaching this line;
- place the pipette on a clean flat surface with the tip exposed, then bring the blood drop into contact with the pipette, which will enter by capillarity. Remove the finger when reaching the black line. If the blood is not enough, continue massaging the finger until reaching this line. Avoid breaking contact between the blood and pipette as much as possible to prevent air bubbles.
7) Take the previously opened vial and immediately deposit the collected blood into it with the pipette. Press the pipette bulb 2 or 3 times and ensure all blood has gone into the diluent solution. Then screw the cap back on and mix well for at least 10 seconds.
8) Unscrew the blue cap from the dropper vial (leave the white cap tightly screwed).
Deposit 3 drops into the designated well on the cassette.
9) Wait 10 minutes and interpret the results.
Negative result: only a colored line appears below the C mark (Control). This result indicates no anti-DGP antibodies in the blood or that their level is below the test's detection limit.
Positive result: two colored lines appear in the reading window at the T (Test) and C (Control) marks. The intensity of the T line may be lower than the C line. The test is considered positive regardless of the T band intensity. This indicates the presence of anti-DGP antibodies in the blood and likely Celiac Disease. Consult your doctor to continue the diagnostic process.
Invalid result: no lines appear or only a line appears below the T (Test) mark and not below C (Control). In this case, the test result cannot be interpreted and is considered invalid; a new test is recommended.

Precautions
1) Keep the test out of reach of children.
2) Do not use the test after the expiration date on the packaging or if it is damaged.
3) Follow the exact procedure 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 blood-thinning medications (anticoagulants) or with hemophilia.
9) After use, dispose of all components according to local regulations; ask your pharmacist for advice.

Storage
Store the test components at temperatures from +4°C to +30°C.

Format
Sealed aluminum protective bag containing: 1 celiac test device and 1 desiccant sachet; 2 sterile lancets for self-puncture blood sampling; 1 dropper vial containing the celiac test diluent sufficient for 1 test; 1 plastic bag containing 1 pipette for blood sampling; 1 antiseptic gauze for skin cleaning and 1 instruction sheet for use.