Exacto Gluten Test

EXACTO® Test Gluten is an easy-to-use, reliable self-test that
can be performed at home for the initial screening of celiac
disease, also known as gluten intolerance.
Celiac disease is a chronic disease of the small intestine
accompanied by a multitude of symptoms of varying intensity,
such as flatulence, diarrhea, abdominal pain, loss of appetite,
weight loss, headache, chronic fatigue, eczema, sleep disorders,
depression, etc.


The causative agent of celiac disease is a peptide, called gliadin,
contained in the dietary gluten. The digestion of gliadin leads to
the formation of deamidated gliadin peptides which, in people
with celiac disease, trigger an abnormal immune reaction with
the production of antibodies responsible for inflammation of the
intestine. EXACTO® Test Gluten is an immunochromatographic
test for the detection of these antibodies specifically produced
in case of celiac disease and directed against deamidated
gliadin peptides.


Being on a gluten-free diet for several months prior to the test
may lead to the disappearance of the celiac disease specific
antibodies and may lead to a false negative result. The screening
disease, and therefore the test, must be performed as part of a
diet contaning gluten to give a reliable result.

Questions and answers

What is the difference between “gluten intolerance” and Celiac disease?
Gluten intolerance is also known as Celiac disease. Celiac disease is a chronic autoimmune bowel disease triggered by the consumption of gluten
or gluten-containing food.
Is a positive result with the EXACTO® Test Gluten self-test sufficient to diagnose celiac disease ?
The EXACTO® Test Gluten self-test allows you to determine at home, quickly and safely whether you are likely to have celiac disease. If this is the
case, consult your doctor for a definitive diagnosis and take the appropriate measures.
I have changed my lifestyle for a gluten-free diet. Can I still use the EXACTO® Test Gluten self-test ?
A gluten-free diet for 1 to 3 months prior to testing may result in the disappearance of celiac disease specific antibodies and may thus interfere with
test positivity. We therefore recommend using the EXACTO® Test Gluten self-test as part of a gluten-containing diet in order to obtain a reliable
result.
The result of my EXACTO® Test Gluten self-test is negative. Am I gluten tolerant ?

The EXACTO® Test Gluten self-test only detects the presence in your blood of anti-deamidated gliadin antibodies characteristic of celiac disease.
Other types of gluten hypersensitivity exist with symptoms suggestive of functional digestive disorders and/or allergic manifestations in subjects
not diagnosed with celiac disease. If your symptoms persist as part of a gluten-free diet despite a NEGATIVE result of the EXACTO® Test Gluten self-test, consult your doctor.

Performance

EXACTO® Test Gluten has undergone assessments. A 96.7% correlation between EXACTO® Test Gluten and an ELISA laboratory test was observed.
- A clinical study performed on 179 sera samples showed that EXACTO® Test Gluten has a sensitivity of 93.8% and a specificity of 97.9%.
- A practicability study conducted with a laymen population showed that 100% of participants obtained a correct and interpretable result.
- A readability study confirmed that 99.1% of the different types of results were interpreted correctly.

Advice for sampling

First, wash your hands with hot water and dry them properly.
Warm water helps improve blood circulation at the fingertips.
You can let your hand hang loose along your body for about 1
minute so that more blood flows into it.
It is recommended to puncture the left hand for right-handed
people, and the right hand for left-handed people.
Preferably prick the tip of the finger on the side : this is where
the blood flow is the highest and the sensitivity is minimal. Avoid
areas where the skin is thicker, so more difficult to prick.
It may happen that a drop of blood does not appear right away.
In this case, you may wait a little and gently massage your finger,
from the base to the pricked area.
If the «S» test well is not completely filled with blood (step 13),
you may form an now drop of blood and transfer it into the «S»
test well using the inverted cup.

PRECAUTIONS FOR USE
• Do not freeze. Keep in a dry place between 2°C and 30°C.
• Remove the test cassette from the sealed pouch and use it within one hour.
• Run the test in a place where the temperature is between 15°C and 30°C.
• This test should be used only from a blood sample and should be performed immediately after blood sample collection at the fingertip.
• Single use.
• The bottom of the sample well must be completely red before adding the diluent.
• Keep the self-test and all components out of children’s reach; ingesting the diluent may be dangerous and the lancet could potentially cause injury.
• Do not use the self-test beyond the expiry date printed on the aluminium pouch and on the carton box.
• A positive result must be confirmed by a histological analysis of the small intestine after biopsy. Consult your doctor to determine the suitability of a gluten-free diet.
• This test does not replace the doctor’s diagnosis. Contact your doctor if you think you are suffering from celiac disease.

 

Erroneous results may be obtained :
- If the test is not used according to the instructions in the package leaflet
- If the aluminum pouch is damaged or if the test is not performed immediately after opening the aluminum pouch,
- If the storage conditions are not respected or if the test is performed after the expiration date on the aluminum pouch.


• The used test cassette and all test components can be disposed of with household waste.
• All components included in the test package are for this test only. Do not reuse the test and / or its components.

 

BIBLIOGRAPHY
- Kelly CP et al. Advances in Diagnosis and Management of Celiac Disease. Gastroenterology. 2015 May;148(6):1175-86. doi: 10.1053/j.gastro.2015.01.044. Epub
2015 Feb 3.
- Niveloni S et al. Antibodies against synthetic deamidated gliadin peptides as predictors of celiac disease: prospective assessment in an adult population with a high
pretest probability of disease. Clin Chem. 2007 Dec;53(12):2186-92. Epub 2007 Sep 27.
- Amarri S et al. Antibodies to deamidated gliadin peptides: an accurate predictor of coeliac disease in infancy. J Clin Immunol. 2013 Jul;33(5):1027-30. doi: 10.1007/
s10875-013-9888-z. Epub 2013 Apr 5.

info(at)tervesyn.com

Kampinkuja 2, Helsinki, 00100 Finland