Basics
Celiac disease is a common digestive condition where the small intestine becomes inflamed and unable to absorb nutrients. It affects about 1% of the Global population, with experts warning that the actual amount of people affected will be much higher because milder cases may go undiagnosed or be misdiagnosed as other digestive conditions, such as irritable bowel syndrome (IBS). Reported cases of celiac disease are two to three times higher in women than men and it can develop at any age.
Celiac disease is caused by an adverse reaction to gluten.
What foods contain gluten?
Gluten is a dietary protein found in any food that contains wheat, barley and rye, including pasta, cakes, bread, breakfast cereal and beer.
What are the symptoms of coeliac disease?
Eating foods containing gluten can trigger a range of gut-related symptoms, such as diarrhoea, abdominal pain, bloating and flatulence (passing wind), indigestion and constipation.
It can also cause a number of more general symptoms, including fatigue, unexpected weight loss and an itchy rash.
Why do I need this test?
There is no cure for coeliac disease, but switching to a gluten-free diet should help control symptoms and prevent the long-term consequences of the condition. Even if you have non-existent or mild symptoms, changing your diet is still recommended because continuing to eat gluten can lead to serious complications. Therefore, it is important to get a diagnosis so that you can make the necessary changes.
What's included in the box?
- Test cassette,
- Vial with dropper containing the diluent sterile lancets,
- Pipette for blood sampling,
- Cleanser gauze,
- Instructions for use
- Please note, the box displayed for this product is only for display purposes
What is required, but not included box?
View the full test instructions here
Principle: Chromatographic Immunoassay
Analyte: IgA and IgG anti-DGP antibodies
Approval: CE
Cut-Off: 20 U/mL/mL
Accuracy: 90%
Country of Origin: Italy
HOW DOES THE CELIAC TEST WORK?
Gliadin is a protein component in gluten responsible for the immune reaction that causes intestinal inflammation in patients suffering from celiac disease. Recent studies of the diagnosis of celiac disease have shown that deamidated gliadin peptides in particular can trigger strong immune reactions. Antibodies directed against these peptides allow to diagnose celiac disease very accurately. The Celiac Test reveals the presence of IgA and IgG antibodies against deamidated gliadin peptides (anti-DGP). A positive result means that the concentration of these antibodies is approximately 20 U/ml (units/ml).
WHEN CAN THE TEST BE USED?
The Celiac Test can be performed when symptoms such as diarrhoea, abdominal pain and swelling, weight loss, fatigue and/or skin reactions are present. The Test can be performed at any time of the day, on a full or empty stomach.
CAN THE RESULT BE INCORRECT?
The result is correct if the instructions are followed carefully. However, the result may not be correct if: the device comes into contact with other liquids before being used, if part of the diluent is accidentally spilt, if the amount of blood mixed with the diluent is not enough or the number of drops dispensed in the well is less than 3 or more than 4. The plastic pipette supplied allows users to be sure they have collected the right amount of blood.
IF I AM ON A GLUTEN-FREE DIET, CAN I TAKE THE TEST?
No. In celiac disease patients on a gluten-free diet the symptoms and the level of disease associated antibodies decrease until they are no
longer detectable.
HOW DO I INTERPRET THE TEST IF THE COLOUR AND INTENSITY OF THE TEST AND CONTROL BANDS ARE DIFFERENT?
The colour and the intensity of the bands are not important for the interpretation of the result. The bands must be full and homogeneous. The test is positive regardless of the intensity and the colour of the test band.
IS THE RESULT RELIABLE IF READ AFTER 15 MINUTES?
No. The test must be read 10 minutes after the procedure is completed (point 9) and no later than 15 minutes from this time.
WHAT SHOULD I DO IF THE RESULT IS POSITIVE?
A positive result means that the levels of class IgA and class IgG anti-DGP antibodies is approximately 20 U/ml. In this case you should consult your GP, who will decide how to proceed.
WHAT SHOULD I DO IF THE RESULT IS NEGATIVE?
A negative result means that the levels of class IgA and class IgG anti-DGP antibodies are below the test’s detection limit. If symptoms persist, seek medical advice.
HOW ACCURATE IS THE CELIAC TEST? The
Test is very accurate. Assessment reports show a concordance rate above 90% (CI 95%: 82-98%) with reference method.
