Verify rapid self test for celiac disease

Product Description

The Verify® Celiac Self Test is a rapid test for the detection of anti-transglutaminase IgA (ttg-IgA) antibodies in capillary blood, useful as an initial screening for celiac disease.

Indications

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 consume gluten. Some more advanced tests also detect: IgA anti-deamidated gliadin peptides (Dgp-IgA), useful in cases of IgA deficiency.

The test is Recommended:

• 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 be effective. give false negatives.

Advantages:

• Quick and painless test.
• Results in 10–15 minutes.
• Useful as an initial screening.

Composition

Active ingredients

The test contains gold particles conjugated with the ttg antigen and anti-human IgA antibodies coated on the membrane.

Method Instructions for use and dosage

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.

Sample collection and preparation:

The Celiac Disease Rapid Test Cassette (whole blood/serum/plasma) can be used This test can be performed using whole blood, serum, or plasma.

To collect fingerstick whole blood samples:

• Wash the patient's hand with warm, soapy water or clean it with an alcohol swab. Allow to dry.
• Massage the hand without touching the puncture site, massaging the hand toward the tip of the middle or ring finger.
• Puncture the skin with a sterile lancet. Discard the first drop of blood.
• Gently rub the hand from the wrist to the palm to the finger to form a rounded drop of blood at the puncture site.
• Add the fingerstick whole blood sample to the test cassette using a dropper or a 20 µL micropipette. The dropper provided with the test delivers approximately 20 µL in one drop, even if more blood is drawn into the dropper.

• Separate the serum or plasma from the blood as soon as possible to avoid hemolysis. Use only clear, 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. Fingerstick whole blood should be tested immediately.
• Bring samples to room temperature before testing. Frozen samples must be completely thawed and mixed well before testing. Samples should not be repeatedly frozen and thawed.
• If samples are to be shipped, they must be packaged in accordance with local regulations. Follow local regulations for the transport of etiological agents.
• EDTA K2, sodium heparin, sodium citrate, and potassium oxalate may be used as anticoagulants for specimen collection.

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.
   Use a dropper: Hold the dropper vertically, aspirate the specimen approximately 1 cm above the tip of the dropper, and then remove the dropper. At the top of the nozzle, 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 10 µL of serum/plasma or 20 µL of whole blood into the sample well (S) of the test cassette, then add 2 drops of Buffer (approximately 80 µL) 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:

Interpretation details:

• 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). The intensity of the color in the test region (T) will vary depending on the concentration of IgA ttg antibodies in the sample. Therefore, any shade of color in the test region should be considered positive.
• Negative: One 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 technique 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 specimen volume and correct procedural technique are used.

Warnings

Precautions:

• For professional in vitro diagnostic use only. Do not use beyond 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 established precautions against microbiological hazards throughout the procedure and follow standard procedures for proper specimen disposal.
• Wear protective clothing such as lab coats, disposable gloves, and eye protection when analyzing specimens.
• Humidity and temperature may adversely affect results.

Limitations:

• The test is not diagnostic: a positive result is considered a serious medical condition. Official blood tests and an intestinal biopsy are required.
• Possible false negatives in cases of selective IgA deficiency (not always detected by the basic test).
• Does not detect non-celiac gluten sensitivity or wheat allergy.
• The Celiac Disease Rapid Test Cassette (whole blood/serum/plasma) is intended for in vitro diagnostic use only. The test should be used for the detection of ttg antibodies exclusively in whole blood, serum, or plasma samples. This qualitative test cannot determine either the quantitative value or the specificity of the test. the rate of increase in the concentration of IgA ttg antibodies.
• 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.
• A negative test result does not exclude the possibility of celiac disease.
• A negative result may occur if the amount of IgA ttg antibodies present in the sample is too high. below the detection limits of the test or if the detected IgA ttg antibodies are not present during the phase of the disease in which the sample is collected.
• If the symptom persists, even if the Celiac Disease Rapid Test Cassette result (whole blood/serum/plasma) is negative, it is recommended to collect the sample again from the patient a few days later or perform the test with an alternative test method.
• Results obtained with this test should be interpreted only in conjunction with other diagnostic procedures and clinical findings.
• The whole blood hematocrit should be between 25% and 65%.

What to do after the test:

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

Storage

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 after the expiration date.

Format

The kit contains:

• Test cassette
• Buffer
• Sterile lancets
• Sample collection container
• Micropipettes