• Verify® Self Test Celiac Disease
  • Verify® Self Test Celiac Disease
  • Verify® Self Test Celiac Disease
  • Verify® Self Test Celiac Disease

Verify® Self Test Celiac Disease

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Verify® Self Test Celiac Disease

🌾 What is the Celiac Disease Test?

The rapid test for celiac disease detects the presence of anti-transglutaminase IgA (tTG-IgA) antibodies in capillary blood.
These antibodies are produced by the immune system of people with celiac disease when they ingest gluten.

📌 Some more advanced tests also detect:

IgG anti-deamidated gliadin peptides (DGP-IgG) → useful in case of IgA deficiency.
🧪 How the Self Test Works

Disinfect your fingertip.
Use the sterile lancet to obtain a drop of blood.
Collect the blood and place it in the test cassette.
Add a few drops of reagent.
Read the result after 10–15 minutes.
Interpretation:
Visible lines Result
✅ Only 1 control line Negative → no antibodies detected
✅✅ 2 lines (control + test) Positive → antibodies present → possible celiac disease
❌ No line or only test line Invalid test → repeat
📅 When to Do It

In case of suspicious symptoms:
Abdominal swelling, diarrhea, weight loss, chronic fatigue, anemia
If you have a family member with celiac disease
If you have associated autoimmune diseases (thyroiditis, type 1 diabetes)
Only if you regularly consume gluten: a gluten-free diet can give false negatives


✅ Advantages

Quick and painless test
Result in 10–15 minutes
Useful as an initial screening
⚠️ Limitations

The test is not diagnostic: if positive, official blood tests and an intestinal biopsy are necessary.
Possible false negatives in case of selective IgA deficiency (not always detected by the basic test).
It does not detect non-celiac gluten sensitivity or wheat allergy.
🩺 What to Do After the Test

Positive → Contact your doctor or gastroenterologist for confirmation with blood tests (anti-tTG, anti-endomysial, DGP) and possible biopsy.
Negative, but with persistent symptoms → further medical attention is still recommended.

【REAGENTS 】
 The test contains gold particles conjugated with the tTG antigen and anti-human IgA antibodies coated on the membrane.
 【PRECAUTIONS】

  •  For professional in vitro diagnostic use only. Do not use after the expiration date.

  •  Do not eat, drink, or smoke in the area where specimens or kits are handled.

  •   Handle all specimens as if they contain infectious agents. Observe precautions.

    established against microbiological risks throughout the procedure and follow the procedures

    standards for the correct disposal of samples.

  •  Wear protective clothing such as lab coats, disposable gloves and face shield.

    the eyes during the analysis of the samples.

  •   Humidity and temperature can negatively affect the results. 【 STORAGE AND STABILITY 】
    The kit can be stored at room temperature or refrigerated (2-30°C). The test cassette is stable until the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
     【 SAMPLE COLLECTION AND PREPARATION 】

  •   The Celiac Disease Rapid Test Cassette (whole blood/serum/plasma) can be performed

    using whole blood, serum, or plasma.

      To collect whole blood samples via fingerstick :

    •   Wash the patient's hand with warm, soapy water or clean it with an alcohol swab. Let it dry.

    •  Massage your hand without touching the sting site, massaging your hand towards the tip of your middle or ring finger.

    •   Puncture the skin with a sterile lancet. Discard the first drop of blood.

    •   Gently rub your hand from wrist to palm to finger to form a drop

      of blood rounded at the puncture site.

    •   Add the fingerstick whole blood sample to the test cassette

      using a 20 μL dropper or micropipette . The dropper supplied with the test

      delivers approximately 20 μL in one drop even if more blood is drawn into the dropper.

  •  Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only

    clear and non-hemolyzed samples.

  •  The test must be performed immediately after sample collection. Do not leave samples at room temperature for extended periods. Serum and plasma samples can be stored at 2-8°C for up to 3 days. For long-term storage, samples should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be performed within 2 days of collection. Do not freeze whole blood samples. Whole blood collected by fingerstick should be tested immediately.

  •   Bring samples to room temperature before testing. Frozen samples must be completely thawed and mixed well before testing. Samples must not be frozen and thawed repeatedly.
     If specimens are to be shipped, they must be packaged in accordance with local regulations for the transport of etiological agents.
     EDTA K2, sodium heparin, sodium citrate, and potassium oxalate can be used as anticoagulants for sample collection.

【 MATERIALS 】

 Buffer Test Cassette
 Sterile lancets

 Sample collection container
 Micropipette

【 INSTRUCTIONS FOR USE 】
 Allow the test cassette, specimen, swab and/or controls to reach room temperature (15-30°C) before testing.

1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it within 1 hour.

2. Place the cassette on a clean, flat surface.
 Using a dropper : hold the dropper vertically, draw up the sample at about

1 cm above the top end of the nozzle as shown in the illustration below, transfer 1 drop of serum/plasma (approximately 10 μL ) or 2 drops of whole blood ( approximately 20 μL) into the sample well (S) of the test cassette, then add 2 drops of Buffer (approximately 80 μL ) and start the timer.

Use a micropipette : pipette and dispense 10μL of serum/plasma or 20μL of whole blood into the sample well (S) of the test cassette, then add 2 drops of Buffer (approximately 80μL ) and start the timer.

3. Wait for the colored lines to appear. Read the result after 10 minutes. Do not interpret the result after 20 minutes.

【 INTERPRETATION OF RESULTS 】
 (Please refer to the illustration above)

POSITIVE : * Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of IgA tTG antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: A colored line appears in the control region (C). No line appears in the test region (T).
INVALID : The control line does not appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.

【 QUALITY CONTROL 】

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. This confirms that sufficient sample volume and correct procedural technique are used.
 【 LIMITATIONS 】

1. The Celiac Disease Rapid Test Cassette (whole blood/serum/plasma) is intended for in vitro diagnostic use only. The test is intended for the detection of tTG antibodies in whole blood, serum, or plasma samples only. This qualitative test cannot determine the quantitative value or rate of increase in IgA tTG antibody concentration.

2.The Celiac Disease Rapid Test Cassette (whole blood/serum/plasma) will only indicate the presence of IgA tTG antibodies in the sample and should not be used as the sole criterion for the diagnosis of celiac disease.

3.A negative test result does not exclude the possibility of celiac disease.
4.A negative result may occur if the amount of IgA tTG antibodies present in the specimen is below the detection limits of the test or if the detected IgA tTG antibodies are not present.

during the stage of the disease in which the sample is collected.
5.If the symptom persists, even if the result of the Celiac Disease Rapid Test Cassette (blood

whole/serum/plasma) is negative, it is recommended to collect the sample again from the

patient a few days later or to perform the test with an alternative testing method.
6. Results obtained with this test should be interpreted only in conjunction with other diagnostic procedures and clinical findings.

7. Whole blood hematocrit should be between 25% and 65%.


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