Self-diagnostic celiac disease test

Product Description

The Munus Test Celiachia Auto is a self-diagnostic test for screening for celiac disease, which detects antibodies to deamidated gliadin (anti-Dgp), IgA, and Igg in the blood.

Indications

Self-test for the determination of antibodies to deamidated gliadin (anti-Dgp), IgA and Igg in the blood for screening for celiac disease.

How to use Instructions for Use

• Wash your hands with warm water and soap, rinse with clean water, and dry or use the provided cleansing gauze.

Note: Using warm water facilitates capillary blood sampling as it induces vasodilation.

• Prepare the necessary materials as follows: open the aluminum pouch, take only the cassette, and discard the desiccant sachet. Open the plastic pouch containing the pipette. Open the vial by unscrewing the white cap, being careful not to drop it.
• Carefully rotate the protective cap of the lancet 360° without pulling it. Remove and discard the released cap.
• Carefully massage the fingertip chosen for the puncture (the side of the ring finger is recommended). It is important to massage from the palm of your hand to the knuckle to improve blood flow. Press the lancet, from the side where the cap was removed, against your fingertip. The tip of the lancet 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.
• Keeping your hand facing downward, 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.
• Hold the pipette without squeezing the bulb. Two methods of sampling are recommended:
  • Hold the pipette horizontally without squeezing the bulb and place it in contact with the drop of blood. By capillary action, the blood will flow naturally. Remove the pipette when it reaches the black line. If there isn't enough blood, continue massaging your finger until it reaches that line.
  • Place the pipette on a clean, flat surface, letting the tip protrude. Then, place the drop of blood in contact with the pipette; it will flow naturally by capillary action. Remove your finger when it reaches the black line. If there isn't enough blood, continue massaging your finger until it reaches that line. Whenever possible, avoid interrupting contact between the blood and the pipette to prevent the formation of air bubbles.
• Take the previously opened vial and immediately pour the blood collected with the pipette into it. Press the pipette bulb 2 or 3 times and make sure all the blood has flowed into the diluent solution. Then replace the screw cap on the bottle and mix well for at least 10 seconds.
• Unscrew the blue cap from the dropper bottle (leave the white cap tightly screwed on). Place 3 drops in the indicated well on the cassette (S).
• Wait 10 minutes and interpret the results as follows.

Interpretation of Results

Read the Result After Exactly 10 Minutes

The intensity of the color of the lines has no bearing on the interpretation of the Test result.

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 detectable limit of 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 should therefore be considered positive regardless of the intensity of the T line. This result indicates the presence of anti-Dgp antibodies in the blood and therefore probable Celiac disease. It is You must consult your doctor to continue the diagnostic process.

Invalid Result

No lines appear or only one line appears under the T (Test) sign and not under the C (Control) sign. In this case, the Test result cannot be interpreted and should be considered invalid. We recommend performing a new test.

Warnings

• Read these instructions for use carefully before performing the Test. The Test is reliable if the instructions are carefully followed.
• Keep the Test out of the reach of children.
• Do not use the Test after the expiration date or if the package is damaged.
• Follow the procedure exactly, respecting the indicated quantities of blood and diluent.
• Do not freeze.
• Use the Test and the finger prick only once.
• The Test is for external use only. Do not swallow.
• In vitro diagnostic device for individual use.
• After use, dispose of all components according to local regulations; ask your pharmacist for advice.

Contraindications

Not recommended for use by people taking medications that thin the blood (anticoagulants) or by people with hemophilia.

Storage

Store the Test components at temperatures between +4°C and +30°C.
Shelf life: In unopened packaging: 24 months.

Format

Package containing:

• Hermetically sealed aluminum pouch containing: 1 ###Celiac Test### cassette and 1 desiccant sachet;
• Sterile lancets for self-pricking blood samples;
• Dropper bottle containing ###Celiac Test### diluent, sufficient for 1 test;
• Plastic pouch containing 1 pipette for blood sampling;
• Alcohol-based cleansing gauze;
• 1 instruction sheet.