GlutenView Gluten Test

Key Benefits

• Rapid at-home celiac screening test
• Designed for private, convenient at-home use
• Detects IgA antibodies to tissue transglutaminase (tTG)
• Uses a minimally invasive, small finger-prick blood sample
• Provides reliable results in approximately 10 minutes
• Offers clear visual, easy-to-read results
• Includes all components needed for testing
• SAHPRA-licensed medical device company

Directions for Use

• Wash your hands before beginning and prepare all test components.
• Use the sterile lancet to obtain a small drop of blood.
• Fill the capillary dropper to the marked line.
• Dispense the blood into the sample well on the test cassette.
• Add 2 drops of buffer.
• Wait 10 minutes before reading the result.
• Two lines at C and T indicate that coeliac-associated antibodies have been detected.
• One line at C indicates that coeliac-associated antibodies have not been detected.
• No line at C indicates an invalid result; repeat the test with a new device.
• Follow the enclosed instruction leaflet for further, more detailed instructions and before interpreting the result.

Safe Handling Guidelines

• Wash your hands before and after sample collection.
• Cover all cuts and abrasions on your hands with a waterproof dressing.
• If using any collection container, ensure it is thoroughly washed and clean, with no soap residue remaining.
• Take precautions whenever handling body fluids and immediately clean and disinfect any spills.
• Always wear gloves and appropriate protective equipment when handling another person’s body fluids.
• Dispose of the used lancet and blood-contaminated components safely after use.

Storage Instructions

• Store in a cool, dry place.
• Keep sealed until ready to use.
• Keep out of reach of children.

Warnings & Precautions

• For single use only.
• Continue eating gluten for 2–4 weeks before testing to support accurate antibody detection.
• This test is a screening tool and does not diagnose coeliac disease or gluten intolerance.
• A positive result should be discussed with a healthcare professional for further assessment and confirmatory testing.
• A negative result does not completely exclude coeliac disease, especially if symptoms persist.
• Consult your healthcare provider before making dietary, treatment or lifestyle changes based on the result.
• This product is not intended to diagnose, treat, cure or prevent any disease.
• Do not reuse the test cassette, lancet or other single-use components.
• Follow the enclosed manufacturer instructions in full before use.

Specifications

• Contains 1 x test unit
• Shelf Life: 12 months

Materials
Plastic.

Allergens
None.

Packaging
Cardboard box.

Country of Origin
Made in South Africa.