Diagnostic Kit for Helicobacter Pylori Antibody
Diagnostic Kit for Helicobacter Pylori Antibody (Colloidal Gold)
Production information
| Model Number | HP-Ab | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic Kit for Helicobacter Pylori Antibody(Colloidal Gold) | Instrument classification | Class III |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Test procedure
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in sample marking. |
| 2 | In case of serum and plasma sample, add 2 drops to the well, and then add 2 drops of sample diluent dropwise. In case of whole blood sample, add 3 drops to the well, and then add 2 drops of sample diluent dropwise. |
| 3 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
Intend Use
This kit is applicable to in vitro qualitative detection of antibody to H.pylori (HP) in human whole blood, serum or plasma sample, which’s suitable for auxiliary diagnosis of HP infection. This kit only provides test results of antibody to H.pylori (HP), and results obtained shall be used in combination with other clinical information for analysis. This kit is for healthcare professionals.
Summary
Helicobacter pylori (H.pylori) infection is closely associated with chronic gastritis, gastric ulcer, gastric adenocarcinoma and gastric mucosa related lymphoma, and H.pylori infection rate in patients with chronic gastritis, gastric ulcer, duodenal ulcer and gastric cancer is around 90%. WHO has listed H.pylori as Class I carcinogen, and identified it as risk factor of gastric cancer. H.pylori detection is an important approach for diagnosis of H.pylori infection.
Feature:
• High sensitive
• result reading in 15 minutes
• Easy operation
• Factory direct price
• Do not need extra machine for result reading
Result reading
The WIZ BIOTECH reagent test will be compared with the control reagent:
| WIZ results | Test resultof reference reagent | ||
| Positive | Negative | Total | |
| Positive | 184 | 0 | 184 |
| Negative | 2 | 145 | 147 |
| Total | 186 | 145 | 331 |
Positive coincidence rate:98.92%（95%C.I. 96.16%~99.70%）
Negative coincidence rate: 100.00%（95%C.I.97.42%~100.00%）
Total coincidence rate:99.44%（95%C.I.97.82%~99.83%）
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