Gluten - self-test for gluten intolerance

Product Description

Rapid test for the detection of antibodies against tissue transglutaminase associated with gluten intolerance and celiac disease in whole blood.

Indications

Sofarmapiù's Gluten Test is a highly specific rapid immunodiagnostic test for the detection of IgA antibodies against tissue transglutaminase from fingerstick whole blood samples.

Directions for use

Place the contents of the box on a clean, dry, flat surface and perform the test. Wash your hands thoroughly. Use warm water and soap. Dry your hands with a clean towel. Prepare the test device and pipette. Remove them from the protective pouch (tear at the notch) and place them within reach. Discard the desiccant sachet. Prepare the lancet. Hold the lancet without touching the trigger button. Unlock the lancet cap by twisting it 1/4 turn until you feel it detach from the lancet, then continue twisting (2-3 turns). Do not pull. Twist and discard the cap when finished. Clean the tip of your middle or ring finger with cotton moistened with alcohol. Rub the chosen finger toward the tip for 10-15 seconds to increase blood flow. Press the device firmly against the lateral side of the previously cleaned finger and press the trigger release button. The tip automatically retracts into the body of the device. Rub the tip of your finger to obtain a sufficient whole blood sample. Without squeezing the bulb, touch the plastic pipette to the blood sample. The blood will migrate through the pipette by capillary action to the line indicated on the pipette. You can rub your finger again to obtain more blood if the line is not reached. Avoid air bubbles as much as possible. Pipette the collected blood into the sample well of the device by pressing on the bulb of the pipette. Wait 30-40 seconds for the blood to be completely absorbed into the sample well. Unscrew the blue cap of the diluent dropper bottle (leave the white cap tightly screwed on) and add the diluent. Hold the dropper vertically and slowly add 4 drops to the sample well of the device, waiting 2-3 seconds between each drop. Read the result after 15 minutes. Do not interpret the result after 20 minutes.

Reading the Results

• Positive: Two colored lines appear, the test line (T) and the control line (C). The test line (T) may have the same color intensity as the control line (C) or a lower color intensity. However, the intensity and color have no bearing on the interpretation of the test results. This result means that the blood sample contains anti-t-TG antibodies. Consult your doctor.
• Negative: Only one colored line, the control line (C), appears. The test line (T) does not appear. This result means that no IgA antibodies to t-TG were detected in the blood sample.
• Invalid: Neither the test line (T) nor the control line (C) appears, or only the test line (T) appears. In this case, the test should be considered invalid. Repeat the test with a new test device and a new blood sample.

Warnings

Read the instructions carefully before performing the test. For in vitro diagnostic self-testing only. For external use only. Do not swallow. Strictly follow the indicated times and the indicated quantities of blood and diluent. The test is interpretable only if the instructions are followed correctly. Do not use if the pouch is opened or damaged. The test is for single use only: do not reuse. Keep out of reach of children. Not suitable for children under 2 years of age.

Storage

Store between 4°C and 30°C. Do not freeze. Do not use after the expiration date. Shelf life if packaged intact: 24 months.

Format

The kit contains: test device, pipette, diluent, sterile lancet, and package insert.