Português

BiocardTM Celiac GLUTEN Self-Test

Available in pharmacies or online :  


Abdominal pain, digestive disorders, weight loss, fatigue...

650,000 people in France are unaware that they are gluten intolerant.

 

Gluten intolerance is also called coeliac disease, which is an autoimmune condition.

 

With just one drop of blood, the Gluten Self-Test effectively tests for gluten intolerance :

 

  • Easy to use

  • Based on the specific detection of tissue transglutaminase IgA antibodies

  • Easy-to-read results in 5 to 10 minutes

Attention, les kits commercialisés à partir d'avril 2017 contiennent une micropipette et non un capillaire de prélèvement. Merci de se référer à la rubrique "Téléchargement des notices"

Who is it for ?

In France, coeliac disease affects 1 person out of 100 or a total of 650,000 people1.

The disease is more common in women : ratio of 2 women for 1 man2.

On average, only 1 person out of 4 is diagnosed2.


Coeliac disease affects both children and adults. There are two at-risk profiles :

  • children and siblings of coeliac patients

  • people with conditions often associated with coeliac disease : autoimmune diseases (type 1 diabetes, active chronic hepatitis), Down's syndrome, Turner syndrome, etc.

  • patients with osteoporosis at an unsual age

  • women with fertility disorders, repeated miscarriages

 

The  BiocardTM Celiac GLUTEN Self-Test is also intended for patients diagnosed with coeliac disease and treated for more than 6 months (who are following a gluten-free diet).

The self-test can also help these patients to make sure that the tissue transglutaminase IgA antibodies have disappeared from their body and therefore that their diet no longer contains any gluten.

 

1Mustalahti K. et al. The prevalence of celiac disease in Europe: results of a centralized, international mass screening project. Ann Med. 2010 Dec;42(8):587-95.

2Fasano A & Catassi C. Clinical practice. Celiac disease, N Engl J Med. 2012 Dec 20;367(25):2419-26.

Why ?

Patients with undiagnosed gluten intolerance are at risk of developing :

  • digestive disorders
  • nutrient and vitamin absoprtion disorders
  • osteoporosis
  • fertility disorders
  • cancer
  • growth retardation in children

 

Coeliac disease is an autoimmune disease:

  • Gluten acts as a food antigen (substance foreign to the body that is able to trigger an immune reaction by developing antibodies). These antibodies include tissue transglutaminase IgA antibodies
  •  It causes chronic inflammation of the intestines


The clinical signs that point to gluten intolerance include :

  • digestive symptoms (nausea, vomiting, intestinal disorders, etc.)
  • and/or non-digestive symptoms (mental, dermatological and/or muscular disorders, deficiencies, etc.)
  • autoantibodies detected following the intake of gluten


Clinical signs alone are not sufficient to diagnose coeliac disease. Serological diagnosis is a crucial step1,2,3,4.

 

The BiocardTM Celiac GLUTEN Self-Test reveals the presence of tissue transglutaminase IgA antibodies that may be associated with coeliac disease. 
The BiocardTM Celiac GLUTEN Self-Test examines the same parameter as the laboratory test.

Potential serious health consequences can be avoided by detecting gluten intolerance early.

This gluten intolerance testing can be done at home using the BiocardTM Celiac GLUTEN Self-Test in the Health self-testing line of products.

 

1Mustalahti K. et al. The prevalence of celiac disease in Europe: results of a centralized, international mass screening project. Ann Med. 2010 Dec;42(8):587-95.

2Fasano A & Catassi C. Clinical practice. Celiac disease, N Engl J Med. 2012 Dec 20;367(25):2419-26.

3Quelles recherches d’anticorps prescrire dans la maladie coeliaque ? Mise à jour en juin 2008 http://www.has-sante.fr.

4Recherche d’anticorps dans la maladie cœliaque : diagnostic et suivi de l’observance du régime sans gluten, Haute Autorité.

How ?

 

1 - Former une goutte de sang 1/2

 

2 - Remplir le capillaire de sang 2/2

 

3 - Diluer l’échantillon de sang dans le tampon de dilution

 

4 - Remplissage de la pipette

 

5 - Déposer 3 gouttes d’échantillon

 

6 - autotest Gluten négatif

 

7 - autotest Gluten positif

 

1 - Former une goutte de sang 1/2

1
2
3
4
5
6
7

The BiocardTM Celiac GLUTEN Self-Test is a serological test that works based on the principle of immunochromatography.
Using one drop of blood taken from the tip of the finger, the  BiocardTMCeliac GLUTEN Self-Test reveals the presence of tissue transglutaminase IgA antibodies. 


The BiocardTM Celiac GLUTEN Self-Test is a screening test for coeliac disease and can be used in both children and adults.

The BiocardTM Celiac GLUTEN Self-Test is sold in all pharmacies in France. It can be done at home. The box contains everything needed to easily perform the screening. .

Users will find the following inside the box :

  • illustrated instructions to help you perform the test
  • a kit for drawing the drop of blood
  • a test used to detect tissue transglutaminase IgA antibodies


The results of the self-test are easy to obtain and read. They appear in the form of a line within only 5-10 minutes.


Characteristics and performance

Packaging : unit kit
Storage : 10 to 27°C
Sample type : capillary blood
Sensitivity*: 96.7%
Specificity*: 93.5%
Feasibility**: 100%


*
Self transglutaminase-based rapid coeliac disease antibody detection by a lateral flow method, RAIVIO et al., Alimentary Pharmacology & Therapeutics, 2006 ; 24 : 147-154.

**Feasibility of a finger prick-based self-testing kit in firstand second-degree relatives of children with coeliac disease, Judith Pichler, Matthias Zilbauer, Franco Torrente, Robert Heuschkel, Alan Phillips, Camilla Salvestrini. World Journal of Gastroenterology 2011; 17(14): 1840-1843.
 

A - Tube with dilution liquid for the sample  
B - Plastic tube containing the small capillary tube to collect the sample
C - Sterile lancet (self-pricking device) 
D - Compress wetted with alcohol
E - Bandage
F - Kit package leaflet
G - Letter for the doctor
H - Aluminium pouch containing one test case (I) and one pipette (J)


Nouvelle version (avril 2017) :


FAQs


The BiocardTM Coeliac GLUTEN tool

What does the BiocardTM Coeliac GLUTEN Self-Test do?

The BiocardTM Coeliac GLUTEN Self-Test uses one very small drop of blood taken from the tip of the finger to detect the presence of tissue transglutaminase IgA antibodies in your body.

If your blood sample contains tissue transglutaminase IgA antibodies, then two lines (test line and control line) will appear on your GLUTEN Self-Test.

What is the use of the BiocardTM Coeliac GLUTEN Self-Test ?

How reliable is the BiocardTM Coeliac GLUTEN Self-Test ?

Where can I buy the BiocardTM Coeliac GLUTEN Self-Test ?

What are the technical characteristics of the test ?

Performing the BiocardTM Coeliac GLUTEN Self-Test

Can I use my BiocardTM Coeliac GLUTEN Self-Test more than once?

I just bought my BiocardTM Coeliac GLUTEN Self-Test. Do I need any other accessories ?

What handling precautions should I take when performing my test ?

Reading and interpreting the results

What does a positive BiocardTM Coeliac GLUTEN Self-Test mean ? And what should I do ?

What does a negative BiocardTM Coeliac GLUTEN Self-Test mean ? And what should I do ?

Are there diseases or medications that could change my BiocardTM Coeliac GLUTEN Self-Test results ?

How is coeliac disease treated and managed ?

I don't have coeliac disease, but I feel better when I eliminate gluten. Should I continue my diet ?

What is the difference from a wheat allergy ?

Precautions and warnings

If the instructions for use are not followed carefully, the test results may be incorrect.

 

A final diagnosis must only be made by a doctor, together with the clinical symptoms.

 

Do not start a gluten-free diet without seeing a doctor.

 

Put all of the items back in the original test box and discard them in the household waste bin.

 

Do not use the test after the expiry date.

 

Do not use the test if the aluminium pouch is damaged. Do not use damaged accessories.

 

After the aluminium pouch has been opened, you must perform the test within 20 minutes.

 

The control buffer contains 0.09% sodium azide. Avoid contact with the skin. Do not swallow!

 

The BiocardTM coeliac disease test is very reliable. Alcohol or painkillers do not affect the test results. The test can give false negative results in only a few medical cases such as IgA insufficiency. If the results of the test are not as you expected, see your doctor.

 

All of the components of this test are intended for this test only. Do not reuse the tests or accessories.

 

The kit contains a medical device, the Actilance lancet, which is produced and CE marked independently by HTL.

 

Keep the BiocardTM Coeliac GLUTEN Self-Test out of the reach of children.

Legal disclosures

The BiocardTM Coeliac GLUTEN Self-Test (ref.: 3-028-200) is a screening test for gluten intolerance that is manufactured by Labsystems Diagnostics, and distributed exclusively by AAZ-LMB France. This test is designed to detect the presence of tissue transglutaminase type A immunoglobulins from a freshly collected sample of capillary blood. When in doubt regarding the result obtained, consult your doctor. This in vitro diagnostic medical device is a regulated healthcare product that is CE marked as required. Read the package leaflet carefully and ask your pharmacist for advice. Internal reference no.: AAZ.AG.14-A (updated on June 7th 2016).

LICENCE no. 15/07/AAZASAN/GP/002