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

Instructions for use
Before starting the test, bring the cassette and 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 vertically on the table.

Unscrew the gray cap of the automatic lancing device by turning it until it loosens. Then, rotate it at least two more times. Only at this point can it be removed, otherwise operation 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 push 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 supplied patch as needed.
Place the filled glass capillary tube into the container with the sample dilution buffer and close 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 until the liquid has collected at the bottom of the container. At this point open the lid of the container.
Only open the foil pouch of the cassette shortly 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 on the sample well (S) and pour exactly 5 drops into it. Make sure that no liquid is spilled on the result window, marked with T and C. After applying the drops, do not touch or move the test cassette.
Once the 5 drops have been added, 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 were 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 almost possible to exclude the presence of glute intolerance