TraceTest™ H. pylori

    • Code: TT0122.050
    • The rapid detection of H. pylori in gastric endoscopy samples.
    • Certificate of Conformity Registration Number: 220003280/PCBB-HCM.
    • Date of Registration: 13/10/2022.
      ✓ Rapid
      ✓ Specific
      ✓ Stable
      ✓ ISO 13485 certified
      • TraceTest™ H. pylori is a specialized gel-based test for the rapid detection of Helicobacter pylori urease. It is contained in a Cryo vial with a screw cap and has an appropriate urea concentration for the quick detection of H. pylori in clinical specimens or culture media.
      • The characteristic feature of H. pylori bacteria is their ability to produce urease enzymes, which rapidly hydrolyze urea into ammonium hydroxide, thereby alkalizing the environment. This alkalization is detected by a pH indicator. If H. pylori is present in the clinical specimen or culture media, the TraceTest™ H. pylori will turn pink within 30 minutes.

      • Step 01: Use a pen to write the sample name on the tube and then open the cap of the TraceTestTM H. pylori tube.
      • Step 02: Use a clamp to transfer the clinical specimen into the TraceTestTM H. pylori tube (If testing on bacteria, use a filter paper with dimensions of approximately 5×3 mm to swipe the bacteria into the TraceTestTM H. pylori tube).
      • Step 03: Screw the cap tightly on the TraceTestTM H. pylori tube and keep it at room temperature.
      • Step 04: Read the result within 1 hour by observing the color change of the TraceTestTM H. pylori tube.
        Interpretation of results:
        – Positive Result: The TraceTestTM H. pylori tube turns pink within 1 hour. “If the color change to pink occurs after 1 hour, it could be a false positive result due to urease-producing bacteria such as Proteus, Klebsiella…”.
        – Negative Result: There is no color change in the TraceTestTM H. pylori tube.
      • The Vial 1.5ml plastic tube with a screw cap contains 0.5ml of gel medium used for the rapid detection of Helicobacter pylori in gastric biopsy samples.
      • Composition: Peptone, Glucose, Sodium chloride, Disodium phosphate, Potassium dihydrogen phosphate, Phenol red, Agar.
      • pH: 6.8 ± 0.2 at 25°C.
      • TraceTestTM H. pylori is a specialized medium used for the rapid detection of H. pylori bacteria. It is contained in a plastic tube, with each tube equivalent to one test used for a clinical specimen or sample.
      Products Code Packaging
      TraceTest™ H. pylori TT0122.050 50 test/box

      1. ISO 13485. LABone-VIE
      2. RESULTS OF CLASSIFICATION OF MEDICAL DEVICES
      3. HSCB ELIGIBLE FOR BUYING AND SELLING MEDICAL DEVICES B, C, D
      4. HSCB qualifies for MEDICAL DEVICE PRODUCTION
      5. HSCB APPLICATION STANDARDS OF CLASS B MEDICAL DEVICES
      6. ANALYSIS SHEET
      7. INFORMATION PRICE DECLARATION OF MEDICAL DEVICES
      8. STANDARD BASE
      9. CLASS B DISCLOSURE DOCUMENT