Cleartest Tissue Transglutaminase Antibody IgA

The CLEARTEST® Anti-Tissue Transglutaminase IgA Rapid Test an immunological test for the qualitative detection of Tissue Transglutaminase IgA IgA (tTG-IgA) antibodies in citrated blood, serum and capillary blood from the fingertip. The test is intended as an aid in the diagnosis of

coeliac disease. The test is intended for use by medically trained personnel only.

Coeliac disease, also known as sprue, is a chronic intestinal disease due to a gluten-sensitive stomach and intestinal lining with a wide range of clinical symptoms, including diarrhoea, digestive disorders, weight loss, malnutrition and skin disorders. In gluten intolerance, the gluten protein from wheat, or analogous proteins (prolamins) in barley, oats and rye, has a toxic effect. Patients suffer damage to the intestinal mucosa with complete flattening of the mucosa, which is reversible on a gluten-free diet. Of diagnostic importance are the tissue transglutaminase antibodies IgA IgA antibodies, especially in the initial diagnosis of suspected coeliac disease, but also as a follow-up. A negative antibody test can rule out the presence of coeliac disease with a high degree of certainty. It is important to exclude an IgA deficiency by determining immunoglobulin A (IgA). Approximately 3 to 7 % of all coeliac disease patients cannot produce antibodies of this type. In this case, the IgA antibody tests cannot be used, as they usually give a negative result even in the case of a full-blown coeliac condition.

The test contains a monoclonal antibody specific for human IgA antibodies,

which is gold-labelled on a membrane zone. The transglutaminase is obtained from the erythrocytes of the whole blood sample. With the help of the lysis buffer, the red blood cells are lysed and the transglutaminase is released.

The CLEARTEST Anti-Tissue Transglutaminase IgA detects samples from a concentration > 5 U/l up to a concentration of 500 U/l.

Performance characteristics

Sensitivity, specificity and accuracy

Anti-tissue transglutaminase IgA rapid tests

• Sensitivity: 98.00 %
• Specificity: 96.67
• Accuracy: 98.00 % (PPV)
• 96.67 % (NPV)

3 step procedure (sample collection, preparation, testing)

Test evaluation after 10 minutes

Can be performed with citrated blood, serum and capillary blood from the fingertip

Store in sealed bag at 2 - 30 °C, do not freeze.