Celiac screen test - rapid test for gluten intolerance

Product Description

Rapid immunochromatographic test that can be used as an aid in the diagnosis of gluten intolerance.

Indications

The Celiac Disease Screen Test can be used as an aid in the diagnosis of gluten intolerance. It detects IgA anti-transglutaminase (tTG) antibodies from a whole blood sample.

If IgA anti-tTG antibodies are present, they bind to colloidal gold-labeled anti-IgA antibodies (mouse IgG) and to tTG (derived from the 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 physician who can Discuss the possibility of a gluten-free diet with the patient.

Directions for Use

Preparing the Test

1. Bring to room temperature (15 °C - 27 °C)
   • Test Cassette
   • Sample Dilution Buffer
2. Opening the Container
   • Remove the lid of the sample dilution buffer and place it upright.

Collecting the Blood Sample

1. Preparing the Lancing Device
   • Unscrew the gray cap of the automatic lancing device by turning it until it clicks into place. does not come loose.
   • Rotate two more times to remove it.
2. Using the Lancing Device
   • Press the lancing device against the side of your clean fingertip and pull the trigger.
3. Collecting Blood
   • Open the plastic container and carefully remove the glass capillary tube.
   • Squeeze a drop of blood from your fingertip.
   • Hold the tube horizontally in the drop of blood until it is completely filled.
   • Use the provided patch as needed.

Preparing the Sample

1. Mixing the Blood
   • Place the Fill a glass capillary tube with the sample dilution buffer and close tightly.
   • Shake the container until the blood is completely mixed with the solution.
2. Preparing the container
   • Wait for the liquid to collect at the bottom before removing the lid.

Performing the Test

1. Preparing the cassette
   • Open the cassette's foil pouch only shortly before use and place it on a flat surface.
2. Applying the sample
   • Use the pipette to remove a few drops of the diluted sample.
   • Hold the pipette vertically over the sample well (S) and dispense exactly 5 drops.
   • Make sure not to spill any liquid on the result window (T and C).
   • Do not touch or move the cassette after applying the drops.

Interpreting Results

1. Reading Results
   • Read the result after 10-15 minutes.
   • Low values ​​may not be detectable for up to 10 minutes.
   • After more than 15 minutes, results may be false positives.
2. Possible Results
   • POSITIVE: One red line (C) and one red line (T). The test indicates the presence of IgA antibodies associated with gluten intolerance. Consult your doctor for a definitive diagnosis.
   • NEGATIVE: One red line (C) and no red line (T). No IgA antibodies for gluten intolerance are detectable. Consult your doctor if symptoms persist.
   • INVALID: No red line (C) or only one red line (T). The test is invalid and must be repeated following the instructions carefully.

Warnings

The test is for external use only.
Do not ingest test components. Avoid contact with skin and eyes with the sample diluent pad.
Keep the test out of reach of children.
The product may cause allergic reactions. Use only until the expiration date printed on the product.
If the instructions for use are not followed correctly and in detail, test results may be distorted. 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 frost. Do not freeze. Store in a dry place at temperatures between 10°C and 27°C.
Shelf life 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 plaster;
• 1 package insert;
• 1 translated information leaflet.