Description
Rapid immunochromatographic test that can be used as an aid in the diagnosis of gluten intolerance. It detects anti-tissue transglutaminase (tTG) IgA antibodies from a whole blood sample.
If anti-tTG IgA antibodies are present, they bind to anti-IgA antibodies (mouse IgG) labeled with colloidal gold and to tTG (derived from the lysis of red blood cells by the dilution buffer). The tTG binds this complex to the static protein line (test line) and produces a visible reddish line. The test also includes a control system consisting of a reference line.
The test result must be confirmed by a doctor who can discuss with the patient the possibility of a gluten-free diet.

Instructions for Use
Before starting the test, bring the cassette and the sample dilution buffer to room temperature (from 15 °C to 27 °C). Open the container with the sample dilution buffer by removing the lid and place it upright on the table.

Unscrew the gray cap of the automatic lancing device by turning it until it loosens. Then, turn it at least two more times. Only at this point can it be removed; otherwise, proper functioning is not guaranteed. The lancing device can be used only once. Press the lancing device with the round opening against the side of the clean fingertip and pull the trigger.
Open the plastic container and carefully remove the glass capillary tube. Squeeze a drop of blood from the fingertip. Hold the glass capillary tube horizontally in the drop of blood until the capillary tube is completely filled. Use the provided bandage as needed.
Place the filled glass capillary tube into the container with the sample dilution buffer and close it tightly with the lid. Shake the container a few times until the blood from the capillary tube is completely mixed with the solution. Before removing the lid from the container, wait for the liquid to settle at the bottom of the container. At this point, open the lid of the container.
Open the aluminum pouch of the cassette just before use. Remove the test cassette and place it on a flat surface. With the pipette, take a few drops of the diluted sample. Hold the pipette with the diluted sample vertically over the sample well (S) and add exactly 5 drops. Ensure that no liquid is spilled on the results window marked by T and C. After applying the drops, do not touch or move the test cassette.
Once the 5 drops are added, read the result after 10-15 minutes. It is possible that low values may not be detected before 10 minutes and that false positive results may occur after more than 15 minutes.

Result Interpretation
POSITIVE: a light or dark red line appears at the control line (C) and a light or dark red line appears at the test line (T).
The test shows that IgA antibodies associated with gluten intolerance have been detected in the blood sample. The detection of these antibodies likely indicates the presence of gluten intolerance. For a definitive diagnosis, consult your doctor.

NEGATIVE: a red line from light to dark appears at the control line (C) and no red line appears at the test line (T).
The test shows that no IgA antibodies indicating gluten intolerance are detectable in the blood sample. Therefore, the presence of gluten intolerance can be almost excluded. In case of gastrointestinal disturbances or other symptoms, further diagnostic investigation by a doctor is necessary.

INVALID: no red line appears at the control line (C) or only a red line appears at the test line (T).
The test has not been performed correctly and is invalid. Ensure that you have followed all the points in the instructions for use exactly. Perform a new test with a new blood sample.

Warnings
The test is intended for external use only.
Do not ingest the test components. Avoid contact of skin and eyes with the sample dilution buffer.
Keep the test out of reach of children.
The product can only be used until the expiration date printed on the product itself.
If the instructions for use are not followed correctly and in detail, the test results may be inaccurate. The final diagnosis must be made by a doctor.
Do not use the test if the packaging is damaged. Do not use damaged test components.

Storage
Do not expose the test to direct sunlight or freezing. Do not freeze. Store in a dry place at a temperature between 10 °C and 27 °C.
Validity in intact packaging: 24 months.

Contents
The kit contains:
– 1 test cassette;
– 1 pipette;
– 1 glass capillary tube;
– 1 bottle of dilution buffer solution;
– 1 sterile lancet;
– 1 alcohol swab;
– 1 bandage;
– 1 instruction leaflet;
– 1 translated information sheet.