RAPID UREASE TEST (rapid urease test) INTENDED USE The Rapid Urease Liquid Test (CLO TEST) by Medil is a culture medium (based on the Remel rapid urease test method) recommended for the detection of urease enzyme activity in gastric mucosal biopsy samples, indicating the presence of Helicobacter Pylori. In clinical trials performed, the RUT TEST, compared to histological examinations as a reference method, yielded a sensitivity of 95% and specificity of 100% due to its high urea content (10%) PROCEDURE 1. Insert the biopsy sample into the vial. 2. Observe for an intense pink-red color in the vial with the biopsy sample, within 20, 30, 60 minutes. This reaction can also be observed by incubating at room temperature . 3. Continue incubation of negative tests for a maximum of 24 hours. The development of an intense pink-red color within 60 minutes is indicative of urease enzyme activity. INTERPRETATION Positive test - An intense pink-red color in the vial with the biopsy sample Negative test - No color change in the vial with the biopsy sample STORAGE This product is ready for use and no further preparation is required. Store the product in its original container at 2-8°C à Has CE Mark/IVD. Result reading within 15-30 minutes . Sensitivity 95.0 % Specificity 100.0 % The package includes : 25 individually packaged tests Sample : Biopsy Fast results Easy visual interpretation Simple operation, no equipment required High accuracy