Descrizione Clinica
SCREEN CHECK TEST
Screen Test Celiac
Description
Rapid immunochromatic test that can be used as an aid in the diagnosis of gluten intolerance. It detects anti-transglutaminese antibodies (tTG) IgA from a whole blood sample.
If there are anti-tTGA IgA antibodies, they bind to anti-IgA antibodies (tope IgG) marked with colloidal gold and tTG (derived by the lisis of red blood cells by the dilution buffer). The tTG binds this complex to the static protein line (the test line) and produces a visible reddish line. The test also includes a control system consisting of a reference line.
The result of the test must be confirmed by a doctor who can discuss with the patient the possibility of a gluten-free diet.
Mode of use
Before starting the test, bring the sample dilution box and pad to room temperature (from 15 °C to 27 °C). Open the container with sample dilution pad by removing the cover and position it vertically on the table.
Unscrew the gray cap of the automatic sting until it loosens. So, turn it at least twice. Only at this point you can remove it, otherwise the operation is not guaranteed. Pungidito can only be used once. Press the sting with the round opening against the side of the clean fingertips and push the trigger.
Open the plastic container and carefully remove the glass capillary tube. To squeeze a drop of blood from the fingertips. Keep the glass capillary tube horizontally in the drop of blood until completely fill the capillary tube. Use the supplied patch as needed.
Place the glass capillary tube filled in the container with the sample dilution pad and close firmly with the cover. Shake the container sometimes until the blood of the capillary tube is completely mixed with the solution. Before removing the lid from the container, wait for the liquid to be collected on the bottom of the container. At this point open the lid of the container.
Open the aluminum envelope of the cassette just before use. Extract the test box and place it on a flat surface. With the pipette, take some drops of the diluted sample. Keep the pipette with the sample diluted vertically on the sample well (S) and pour exactly 5 drops. Make sure no liquid is poured on the results window, marked by T and C. After applying the drops, do not touch or move the test cassette.
Once you add the 5 drops, read the result after 10-15 minutes. It is possible that low values are not detected before 10 minutes have passed and false positive results occur after more than 15 minutes.
Interpretation of results
POSITIVE: a clear or dark red line appears at the control line (C) and a clear or dark red line 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 a gluten intolerance. For a definitive diagnosis, consult your doctor.
NEGATIVO: A red line from clear to dark at the control line (C) appears and no red line appears at the test line (T).
The test shows that in the blood sample are not detectable IgA antibodies that indicate a gluten intolerance. It is therefore almost possible to exclude the presence of gluten intolerance. In case of gastrointestinal disorders or other symptoms, further diagnostic analysis is required by the doctor.
NOT VALIDO: no red line appears at the control line (C) or only a red line appears at the test line (T).
The test was not performed correctly and is not valid. Verify that you have followed exactly all instructions for use. Run a new test with a new blood sample.
Warnings
The test is intended exclusively for external use.
Do not ingest the test components. Avoid skin and eyes contact with the diluent sample pad.
Keep the test out of the reach of children.
The product can only be used at the printed expiry date on the product itself.
If the instructions for use are not followed correctly and in detail, the test results can be falsified. 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. Don't freeze. Store in a dry place at temperature between 10 °C and 27 °C.
Validity of whole packaging: 24 months.
Format
The kit contains:
- 1 test box;
- 1 pipette;
- 1 glass capillary tube;
- 1 solution bottle with sample dilution pad;
- 1 sterile hand;
- 1 swab filled with alcohol;
- 1 plaster;
- 1 leaflet;
- 1 information sheet translated.
Rapid immunochromatic test that can be used as an aid in the diagnosis of gluten intolerance. It detects anti-transglutaminese antibodies (tTG) IgA from a whole blood sample.
If there are anti-tTGA IgA antibodies, they bind to anti-IgA antibodies (tope IgG) marked with colloidal gold and tTG (derived by the lisis of red blood cells by the dilution buffer). The tTG binds this complex to the static protein line (the test line) and produces a visible reddish line. The test also includes a control system consisting of a reference line.
The result of the test must be confirmed by a doctor who can discuss with the patient the possibility of a gluten-free diet.
Mode of use
Before starting the test, bring the sample dilution box and pad to room temperature (from 15 °C to 27 °C). Open the container with sample dilution pad by removing the cover and position it vertically on the table.
Unscrew the gray cap of the automatic sting until it loosens. So, turn it at least twice. Only at this point you can remove it, otherwise the operation is not guaranteed. Pungidito can only be used once. Press the sting with the round opening against the side of the clean fingertips and push the trigger.
Open the plastic container and carefully remove the glass capillary tube. To squeeze a drop of blood from the fingertips. Keep the glass capillary tube horizontally in the drop of blood until completely fill the capillary tube. Use the supplied patch as needed.
Place the glass capillary tube filled in the container with the sample dilution pad and close firmly with the cover. Shake the container sometimes until the blood of the capillary tube is completely mixed with the solution. Before removing the lid from the container, wait for the liquid to be collected on the bottom of the container. At this point open the lid of the container.
Open the aluminum envelope of the cassette just before use. Extract the test box and place it on a flat surface. With the pipette, take some drops of the diluted sample. Keep the pipette with the sample diluted vertically on the sample well (S) and pour exactly 5 drops. Make sure no liquid is poured on the results window, marked by T and C. After applying the drops, do not touch or move the test cassette.
Once you add the 5 drops, read the result after 10-15 minutes. It is possible that low values are not detected before 10 minutes have passed and false positive results occur after more than 15 minutes.
Interpretation of results
POSITIVE: a clear or dark red line appears at the control line (C) and a clear or dark red line 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 a gluten intolerance. For a definitive diagnosis, consult your doctor.
NEGATIVO: A red line from clear to dark at the control line (C) appears and no red line appears at the test line (T).
The test shows that in the blood sample are not detectable IgA antibodies that indicate a gluten intolerance. It is therefore almost possible to exclude the presence of gluten intolerance. In case of gastrointestinal disorders or other symptoms, further diagnostic analysis is required by the doctor.
NOT VALIDO: no red line appears at the control line (C) or only a red line appears at the test line (T).
The test was not performed correctly and is not valid. Verify that you have followed exactly all instructions for use. Run a new test with a new blood sample.
Warnings
The test is intended exclusively for external use.
Do not ingest the test components. Avoid skin and eyes contact with the diluent sample pad.
Keep the test out of the reach of children.
The product can only be used at the printed expiry date on the product itself.
If the instructions for use are not followed correctly and in detail, the test results can be falsified. 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. Don't freeze. Store in a dry place at temperature between 10 °C and 27 °C.
Validity of whole packaging: 24 months.
Format
The kit contains:
- 1 test box;
- 1 pipette;
- 1 glass capillary tube;
- 1 solution bottle with sample dilution pad;
- 1 sterile hand;
- 1 swab filled with alcohol;
- 1 plaster;
- 1 leaflet;
- 1 information sheet translated.
