Description
Rapid immunochromatographic test that can be used as an aid in the diagnosis of gluten intolerance. Detects IgA anti-transglutaminase (tTG) antibodies from a whole blood sample.
If anti-tTGA IgA antibodies are present, they bind to colloidal gold-labeled anti-IgA antibodies (mouse IgG) and to tTG (derived from lysis of red blood cells by the dilution buffer). 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.

How to use
Before starting the test, bring the cassette and the sample dilution buffer to room temperature (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 then can it be removed, otherwise its function is not guaranteed. The lancing device can only be used once. Press the lancing device with the round opening against the side of the clean fingertip and press the trigger.
Open the plastic container and carefully remove the glass capillary tube. Squeeze a drop of blood from your fingertip. Hold the glass capillary tube horizontally in the drop of blood until the capillary tube is completely filled. Use the provided plaster as needed.
Place the filled glass capillary tube into the container with the sample dilution buffer and close the lid tightly. Shake the container a few times until the blood in the capillary tube is completely mixed with the solution. Wait until the liquid has collected at the bottom of the container before removing the lid from the container. Then open the lid of the container.
Open the foil pouch of the cassette only shortly before use. Remove the test cassette and place it on a flat surface. Use the pipette to 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. Make sure that no liquid gets on the result window, marked T and C. After applying the drops, do not touch or move the test cassette.
After adding the 5 drops, read the result after 10-15 minutes. Low values ​​may not be detected until 10 minutes have passed and false positive results may occur after more than 15 minutes.

Interpretation of results
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 most likely indicates the presence of gluten intolerance. For a definitive diagnosis, consult your doctor.

NEGATIVE: A light to dark red line 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. It is therefore possible to almost completely exclude the presence of gluten intolerance. In case of gastrointestinal disorders or other symptoms, further diagnostic investigation by the doctor is necessary.

INVALID: No red line appears at the control line (C) or only one red line appears at the test line (T).
The test was not performed correctly and is invalid. Make sure you followed all the steps 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 test components. Avoid skin and eye contact with specimen diluent pad.
Keep the test out of the reach of children.
The product can only be used until the expiry date printed on the product itself.
If the instructions for use are not followed correctly and in detail, the test results may be false. 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.

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

Format
The kit contains:
- 1 test cassette;
- 1 pipette;
- 1 glass capillary tube;
- 1 bottle of solution with sample dilution buffer;
- 1 sterile lancet;
- 1 alcohol swab;
- 1 patch;
- 1 leaflet;
- 1 translated information sheet.