Picture of BIOSYNEX Gluten rapid test
Product: BIOSYNEX_858865

BIOSYNEX Gluten rapid test

Origin:France

Detail

  • Sensitivity 93.8% / Specificity 97.9%
  • Suitable for 3 years old or above
  • 1 drop of blood sampling for the test
  • Rapid test (results in 10 minutes)
  • CE marking (CE0123)
  • Made in France, quality guaranteed

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Gluten is a protein found in wheat, barley and rye. It is a composite of two proteins: gliadin and glutenin. Some people have unpleasant symptoms after ingesting gluten.

 

Celiac disease

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.

 

Gluten-free diet is specifically beneficial to people who are allergic to gluten and celiac patients. Gluten does no harm to normal healthy individuals so it is unnecessary for us to go gluten-free.

 

Symptoms of celiac disease are similar to those of common gastrointestinal diseases. It is difficult for ordinary people to judge whether they are celiac disease through the symptoms.

 

EXACTO® Test Gluten self test 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 containing gluten to give a reliable result.

 

High Accuracy

EXACTO® Test Gluten self test has undergone assessments. A 96.7% correlation between EXACTO® Test Gluten self test and an ELISA laboratory test was observed.

  • A clinical study performed on 179 sera samples showed that EXACTO® Test Gluten self test 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

 

Instructions

  1. Have a watch or a timer
  2. Wash your hands with soap and warm water, then dry them before processing to the next step
  3. Open the box and remove all the items from their packaging. Place them on a dry, clean surface. Identify each item of the kit
  4. Open the pouch and remove the cassette. Use the test within one hour
  5. Unscrew the cap of the diluent bottle and place it vertically on the working area
  6. Take the alcohol wipe out of its pouch and disinfect the tip of the finger chosen for sampling
  7. Remove the sterile pad from its pouch and wipe off the traces of alcohol
  8. Remove the cap from the lancet
  9. Apply the lancet on the fingertip. Trigger it by pressing firmly on the other end
  10. Squeeze the tip of the finger to form a large drop of blood
  11. Place the flared part of the inverted cup in contact with the drop of blood to fill the cup entirely
  12. Immediately transfer the drop of blood intothe S well of the cassette (the drop of blood must be in direct contact with the bottom of the well)
  13. Check that the bottom of round well S is completely red before proceeding to the next step. Otherwise, form a new drop of blood by pressing firmly the tip of the pricked finger
  14. Unscrew the cap of the diluent bottle. Transfer 3 drops into the S round well of the cassette
  15. Start the timer or write down the time of deposit. Wait 10 minutes to read the result. Do not read beyond 20 minutes. During this time you can put on the plaster

 

*Chinese version for reference only, if there is any inconsistency or ambiguity between the original version and the Chinese version, the original version shall prevail.

 

 

Results

  • Positive: If a colored band is visible both in the control zone (C) and in the test zone (T). A positive result indicates the presence of anti-deamidated gliadin antibodies and suggests with a high probability the diagnosis of celiac disease. Please, consult your doctor for a definitive diagnosis and adequate treatment.
  • Negative: If a colored band appears only in the control zone (C). No colored band appear in the test zone (T). A negative result indicates the absence of anti-deamidated gliadin antibodies and thus avoids the risk of celiac disease. If symptoms persist as part of a gluten-containing diet, consult your doctor.
  • Invalid: If no colored band is visible in any zone, or if no colored band appears in the control zone (C). You may perform a new test.

 

 

Precautions

  • Do not freeze. Keep in a dry place between 18°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 this test are for this test only. Do not reuse this test and / or its components. 

 

Storage

Store in a dry place at a temperature between 18°C and 30°C. Do not freeze.

General Terms:

  • Items sold are non-refundable.
  • The quality assurance for products should have at least 9 months validity from the date of receipt by the customer.
  • The products are supplied by Intuitive Technology Limited.
  • If in case of any dispute, Intuitive Technology Limited and Health.ESDlife reserve the right of final decision.

 

Delivery Terms:

  • Free local delivery service will be provided upon transaction amount of HK$300. For spending less than HKD$300, HKD$50 delivery fee will be charged.
  • We will arrange the shipment within 3 working days after the order is confirmed. 
  • Please note that the delivery time will be affected by statutory holidays, natural disasters, traffic or the weather.
  • All order confirmations are subject to stock availability. In the event of the unavailability of the requested products, health.ESDlife has the right to reject the order and notify customers by phone or email before delivery for rearrangements.

 

Exchange Policy:

  • Customers are responsible to check the condition of goods received at the time of delivery. Once confirmed, no replacement is accepted.
  • Products shall be kept in the original package with good conditions for return or exchange. Products that has been worn, used, or altered will not be accepted for return or exchange.
  • If any other defective or missing item is found, customers are required to keep the original receipt and contact Intuitive Technology Limited Customer Service Department via the below channels within 3 days from the date of delivery.
    Email: sales@intuitivetechnology.com.hk
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