How does IgA + IgG Gluten Screening Test work?
IgA + IgG Gluten Screening Test gives a positive result if you have antibodies (IgA or IgG) to Tissue Transglutaminase (tTG) that are associated with coeliac disease. If you have an IgA deficiency, which is more common in coeliac patients than normal, the test is positive if you have only IgG antibodies to tTG. The presence of at least one type of these antibodies indicates that there is a high probability that you have coeliac disease. If the test is negative and neither type of antibody has been detected then coeliac disease can be virtually ruled out.
When should the test be used?
If you have one or more of the symptoms of coeliac disease including diarrhoea, abdominal bloating, weight loss, skin ailments or signs of malnutrition, taking the Gluten Plusz test for the condition is recommended.
ABOUT THIS TEST
IgA + IgG Gluten Screening Test is a simple, rapid and reliable home diagnostic test to detect the presence of coeliac disease associated IgA and IgG anti-transglutaminase antibodies in a finger tip sample of human blood.
Coeliac disease is a serious gastrointestinal autoimmune disorder that occurs in predisposed people of all ages from middle infancy onwards. It is a common condition affecting up to 1% of population and causes a wide range of symptoms such as diarrhoea, abdominal bloating, weight loss, skin ailments and signs of malnutrition. Coeliac disease is caused by a permanent intolerance to gluten, a group of proteins found in wheat, barley, rye and many other cereals, which results in an immune response and specific antibodies (IgA and IgG) to tissue transglutaminase being produced.
Gluten Plusz is used to support the diagnosis of coeliac disease, which must then be confirmed by your doctor. The clinical advice is normally to adopt a gluten-free diet to avoid the symptoms of the disease. A gluten-free diet will decrease disease symptoms and also the levels of the coeliac disease-associated IgA and IgG antibodies. These will often become undetectable a few weeks after adoption of the diet, and certainly within 6 weeks so if you are on a gluten-free diet, it is likely that your test result will be negative. A gluten free diet should only be followed in accordance with a physician’s instruction.
1x sealed foil pouch containing:
- 1x test cassette in a sealed foil pouch.
- 1x dropper bottle containing 1ml of test diluent (single use).
- 1x sterile single use lancet for blood sampling (Dir. 93/42/EEC CE0120 Vitrex Medical A/S, Vasekaer 6-8, 2730 Herlev DENMAR).
- 1x micropipette.
- 1x Alcohol Swab (Dir. 93/42/EEC Class 1 Vitrex Medical A/S, Vasekaer 6-8, 2730 Herlev DENMARK).
- 1 x Instruction sheet.
Please note you will also need a watch with a second hand, clean paper tissues and a plaster (optional)
Important – Read these test instructions carefully before use
- Always read the instructions carefully before performing the test as it is only possible to interpret the results if the procedure is carried out exactly as instructed.
- Keep out of the reach of children.
- FOR EXTERNAL USE ONLY. DO NOT SWALLOW; the diluent (DIL) contains 0.01% Proclin 300.
Use only as an in vitro diagnostic device for self-testing purposes.
- Do not use this test if you suffer from a blood clotting disease.
- Alcohol and local anaesthetics do not affect the test.
- If blood comes in contact with any surfaces, wipe clean with disinfectant.
- DO NOT RE-USE. This is a single use test.
- Do not use after the expiry date printed on the box label and on the foil pouch, or if the pouch is damaged.
- Store between +8°C and +25°C. Do not freeze.
- DISPOSAL. After use place the test cassette, used lancet, micropipette, buffer bottle and swab inside the foil pouch, replace in box and dispose of with your normal household waste.
- Open the foil pouch and remove the test cassette. The desiccant bag is not required and can be discarded with the pouch.
- Familiarise yourself with the components of the test.
- Ensure you have plenty of light and a hard flat surface available on which to lay the cassette when you perform the test.
- Ensure all components have reached room temperature before starting.
- Read the instructions thoroughly before taking the test.
- You will also need to have a watch with a second hand ready and a clean paper tissue.
- When ready to start the test wash your hands with soap in warm water to soften the skin and encourage blood flow in your fingers. Rinse thoroughly and dry.
Collect the blood sample
- Hold the lancet by its sides at one end and then twist and pull the blue coloured plastic cap from the other end (1).
Warning: Do not use the Lancet if the cap has been removed or is missing.
- Choose a site on the finger as indicated by the shaded areas of the picture (2). Avoid areas of hard skin.
- Clean the site with the alcohol swab provided in the kit
- Allow the site to dry thoroughly
- Press the end of lancet firmly against the cleaned site on your finger until the lancet is triggered (4).
- A small drop of blood will appear. Massage the finger towards the tip to encourage the blood to flow and a drop to form.
- Touch the end of the micropipette against the blood drop.(6) Do not squeeze the bulb of the pipette as the blood will be drawn into the pipette automatically.
Quickly continue to massage the finger to give the next drop of blood and draw the blood into the pipette in quick succession until it reaches the black line on the pipette
Note: If the blood flow stops during collection let your arm hang loosely at your side for a short time and then massage your finger again. This usually restarts the blood flow.
Testing the sample
- Quickly drop the blood from the pipette into the round well on the cassette labelled with an arrow by squeezing the bulb at the end of the pipette.
- Ensure all of the blood in the pipette is removed and if necessary also squeeze the tube of the pipette and cover the ventilation hole on the nozzle with a finger.
- Wait 60 seconds and then add three drops of test diluent into the round sample well from the single-use dropper bottle (DIL).
- Make a note of the time and wait 5 minutes.
- You will start to see the blood sample/diluent mix migrate up the test cassette. Do not move the cassette until the test time has completed.
- After 5 minutes check for the presence of a blue line in the cassette window near to the ‘C’ control mark and a possible red line near to the ‘T’ test mark.
- Do not read the result after 10 minutes.
Reading the results
Positive: A blue coloured line in the window near to the ‘C’ control mark and a red coloured line near the ‘T’ test mark means that the test is positive.
Negative: A blue coloured line in the window near to the ‘C’ control mark and no red coloured line near the ‘T’ test mark means that the test is negative.
Non Valid result : A blue coloured line should always appear near the ‘C’ control mark. If there is no blue coloured line the test is invalid, even if a red line appears near the ‘T’ test mark.
Please note: In addition to the blue line by the ‘C’ control mark, ANY red line seen near the ‘T’ test mark of the cassette after the 5 minute test time is considered POSITIVE. The intensity of the coloured lines does not matter.
QUESTIONS AND ANSWERS
- Is the test result correct?
Gluten Plusz has been validated against laboratory tests and has been shown to be very reliable, (96.5% sensitivity, 97.3 Specificity), provided the instructions are followed carefully. The test can only give a false negative result in rare cases, such as when the levels of tTG antibodies are very low. Please note however that the test result can be adversely affected if insufficient blood is used or it is dispensed incorrectly.
- How to interpret the test if the colour and intensity of the lines are different?
The intensity of the coloured test lines are of no importance in the interpretation of the result. The coloured lines only need to be uniform and clearly visible and a red line of any intensity by the ‘T’ test mark should be regarded as positive.
- If I read the result after 10 minutes, will the result be reliable?
No, the result should be read within 10 minutes of adding the test diluent and is reliable only up to this time
- What should I do if the test result is positive?
Gluten Plusz is a screening test for coeliac disease and a positive test result indicates that you have coeliac associated IgA or IgG antibodies. We would recommend that you seek medical advice from your doctor who will conduct further supporting laboratory tests and take into account any symptoms of the condition that you may have before making a definitive diagnosis. Only start a gluten-free diet on the advice of your doctor.
- What should I do if the test result is negative?
A negative test result indicates that it is very unlikely that you have coeliac disease. However, as no test is 100% effective and it is known that very low antibody levels the test may give a false negative result, we recommend that you consult your doctor if you have worrying gastrointestinal symptoms or the test result is contrary to your expectations.