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