VITAMIN STATION Quick Test Gluten Alarm

327,-

VITAMIN STATION Quick Test Gluten Alarm

A self-diagnostic rapid test for the detection of IgA antibodies to tissue transglutaminase associated with celiac disease (gluten intolerance) from a blood sample. Celiac disease is a lifelong autoimmune disease affecting the small intestine that can occur in people with a genetic predisposition. The disease is caused by an intolerance to foods containing gluten, which are various proteins found in wheat, barley and rye. It is estimated to affect 1% of people worldwide. Typical symptoms include chronic diarrhea, abdominal pain, bloating, losing weight, anemia, osteoporosis, chronic fatigue and slow growth in children. Once the disease has been diagnosed, the only currently known effective treatment is a lifelong strict gluten-free diet. Currently, highly effective blood sample tests are the first screening method for detecting celiac disease. They are mainly based on the detection of IgA-type antibodies against tissue transglutaminase (t-TG). The celiac disease test is a highly specific immunological rapid test for the determination of IgA antibodies to t-TG from a finger prick blood sample.

Scope:
1 sealed aluminium bag containing: 1 test cartridge, 1 plastic pipette, 1 bag of desiccant, 1 sterile lancet for blood collection, 1 dropper bottle containing 1 ml of buffer solution, 1 instruction manual, 1 disinfectant swab with alcohol
Note:
This test is intended for in vitro diagnostic use only. For external use only. DO NOT TAKE INTERNALLY.
Read the instructions carefully before taking the test. The test gives a reliable result only if all instructions are followed exactly.
Consistently observe the specified time, amount of blood and buffer solution.
Store at a temperature of +4 to +30 °C. Do not freeze.
Do not use the test after the expiry date on the label and on the protective bag, or if the bag is damaged.
The celiac test is designed for single use.
Keep out of reach of children.
After use, all parts of the test can be disposed of as municipal waste.
Not suitable for children under 2 years of age.
Open the protective bag only when you are ready to use the test immediately.
The desiccant bag is not intended for testing.
How does the celiac test work?
When gluten intolerance is present, the production of specific IgA antibodies against t-TG The test allows the detection of these specific antibodies and therefore provides evidence of gluten intolerance. The sensitivity of the test is 10 U/ml.
When should this test be used?
It should be done if there are symptoms of gluten intolerance or if family members already have this problem. This disease actually occurs in genetically predisposed individuals. The test should be done on a regular diet (not a gluten-free diet) to get a valid result.
Could the result be incorrect?
The results are reliable provided that all instructions have been carefully followed. However, the result may be incorrect if the celiac test has been exposed to moisture before use or if the blood sample amount is too low. The plastic pipette supplied in the package allows you to ensure the correct volume of blood drawn.
How to evaluate the test if the colour or intensity of the lines is different?
Neither the colour nor the intensity of the lines have any influence on the interpretation of the result. The lines must be clearly visible and homogeneous. The test must be evaluated as positive, regardless of the colour intensity of the test line.
What does the comma under the letter C stand for?
When this comma appears, it means that the test worked well.
If I read the test after 20 minutes, is the result still reliable?
No. The result must be read within 15 minutes after the addition of the buffer solution. Do not evaluate the test after 20 minutes.
What should I do if the test is positive?
If the result is positive, it means that IgA antibodies against t-TG are present in the blood. We recommend that you consult your GP and show them the test result. The doctor will then decide whether further tests should be carried out.
What should I do if the test is negative?
If the result is negative, it means that the test has not shown the presence of IgA antibodies against t-TG in the blood. In limited cases, IgA deficiency can also lead to false negative results. See a doctor if the problem persists.
What is the accuracy of the gluten intolerance test?
This test is accurate. Evaluation studies show at least 97% agreement with reference methods. Although the test is reliable, there may be the occasional false negative or false positive result.

Warning: Use the medical device in accordance with the instructions for use. Carefully read the information on safe use of the device. Keep out of reach of children.

Specifications

Medical device

Type of medical device In vitro diagnostic medical device (IVD)

Product characteristics

Product characteristics Medical device

Usage

Designed for Adults and children
From age 2 years (24 months)

Use

Zaměření testu na Gluten intolerance

Basic information

Evaluation method Instant results (self-diagnosis)
Method of test performance Blood
Collection point Home
Evaluation time 15 min
Usability Disposable
Brand Vitamin Station

Number of pieces in package

Number of pieces in package 1 pc(s)
Code:  SPTmap020
Warranty: 24 months
Manufacturer information

Vitamin Statium Slovakia s.r.o., Hontianska 4, 936 01 Šahy

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