Helicobacter Pylori Antigen (H. Pylori Ag)
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VeriGoldTM 幽门螺杆菌抗原
The VeriGoldTM H. pylori Ag Rapid Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human fecal samples. It is intended for use in clinical and point-of-care settings to aid in the detection of H. pylori infection, a major cause of chronic gastritis and peptic ulcer disease, and may be associated with gastrointestinal symptoms such as dyspepsia, abdominal pain, nausea, vomiting, and acute gastroenteritis-like episodes.
As a non-invasive qualitative test, results are reported simply as positive or negative, enabling rapid detection of active infection. Results are available within minutes from a fecal sample, making this test useful for initial screening, confirmation of infection in symptomatic patients, and post-treatment follow-up to assess eradication success in outpatient clinics and primary care settings.
| Ref. Code | 808120 |
| Analyte | Helicobacter pylori antigen |
| Format | POCT rapid test (cassette / cartridge) |
| Diagnostic Readout | Qualitative |
| Reading Time | 10 minutes |
| Measuring Range | Not applicable |
| Cut-off Value | Not applicable |
| Sensitivity / Specificity | 98.6% / 98.32% |
| Storage Conditions | 2–25°C |
| Shelf Life | 18 months |
| Certificate | CE, NMPA |
| Sample Types | Human fecal sample |
| Sample Volume | Please refer to Collection Method |
| Collection Method | - Collect stool using the sampling stick from three different sites of the specimen and place into the extraction buffer (1.5 mL). - Mix thoroughly. - Add 3 drops (~100 µL) of the extracted sample to the test device. |
| Sample Stability | Stable for testing within 1 hour at room temperature (as validated) |
| Acceptable Anticoagulants | Not applicable |
| Notes on Handling | Specimens should be collected and handled using standard laboratory procedures. Use fresh samples when possible and avoid hemolyzed, lipemic, or contaminated specimens. |
| Detection Method | Immunochromatography |
| Antibody Format | Monoclonal / sandwich |
| Signal Generation | Colloidal gold |
| Reading Method | Visual |
| Mechanism | The assay is based on an immunochromatographic sandwich lateral flow principle, in which Helicobacter pylori antigens present in the fecal sample bind to specific labeled antibodies during migration along the membrane by capillary action. The resulting antigen–antibody complexes are captured by immobilized antibodies at the test line, producing a visible signal indicating the presence of H. pylori antigens in the specimen. |
| Tests per Kit | 20 Tests |
| Dimension of Kit Box | 16.5 × 13.5 × 8cm |
| Boxes per Carton | 55 Kits |
| Tests per Carton (Bulk) | 1100 Tests |
| G.W. per Carton (Boxed) | 22.3 kg |
| G.W. per Carton (Bulk) | 25.6 kg |
| Carton Dimension | 67 × 57.5 × 39 cm |
| Carton Volume | 0.15 CBM |
| Packaging Format | Individual sealed test kits / bulk configuration (as applicable) | Items Included |
- 20 test cassettes - 20 patient sets: - Collection tube pre-filled with buffer (1.5 mL per vial) - Stool collection paper - Sample collection instruction manual - Instructions for Use |
| Storage & Shipping Conditions | Standard ambient transport; store according to product label requirements |
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深圳市康生保
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