Introduction TopSENSI ® HP Clotest
Helicobacter pylori a common stomach pathogen that causes gastritis, gastric ulcers, gastric adenocarcinoma, and low-grade gastric lymphoma. The infection can be asymptomatic or cause indigestion of varying degrees.
HP infection is one of the most common chronic bacterial infections in humans. It is estimated that over 50% of the population has been infected with HP, primarily in developing countries where infection rates are very high, ranging from 50-90% in individuals over the age of 20, and most children are infected between the ages of 2-8. Vietnam also has a high HP infection rate, around 70% in adults. In developed countries, the age of infection is typically over 50, affecting more than 50% of the population. This rate increases by 10% each year.
The primary transmission route is via the oral-fecal (fecal-oral) or direct (oral-oral) route through saliva. In areas with poor sanitation, contaminated water and food are the primary initial sources of transmission.
TopSENSI ® HP Clotest s a biochemical reagent kit designed by ABT to detect Helicobacter pylori bacteria from gastric biopsy samples (body, antrum, pylorus regions), esophagus, duodenum, or culture medium.
Highlights
- Simple procedure
- Fast extraction time
Specification
| Sample types | Gastric biopsy sample or culture medium |
| Sensitivity | 100% |
| Specificity | >98.08% |
| Accuracy | >99.9% |
| Level of bacterial detection | 5 CFU/reaction |
| Level of asepsis | No presence of other microorganisms |
| Storage | 2 – 8oC, 06 months from the date of manufacture |
| Kit components | Urea ≥ 2%, Phenol red ≥ 0.04g, agar ≥ 4.0g, Na₂HPO₄, KH₂PO₄ |
Result analysis
| Reagent color | Results | Note |
| Color changes from yellow to dark pink within 5 minutes
| Positive | The sample containing H. pylori exhibits high enzymatic activity. |
| Changes from yellow to pink red within 30 minutes.
| Samples containing low levels of H. pylori or obtained from patients with regressed H. pylori infection. | |
| Changes from yellow to orange after 30 minutes.
| Negative | Color change may result from samples containing very low levels of H. pylori, contamination with Proteus or Morganella species, or temporary effects caused by gastric pH. |
| The medium does not change its yellow color after 30 minutes.
| Negative |

Hình 1. Reagent sample after performing the reaction.
1: Reagent sample when the reaction is negative
2: The sample needs to be reviewed after 30 minutes.
3, 4: Reagent sample when the reaction is positive
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Read more: Instructional Video for Qualitative Real-time PCR Kit






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