H-pylori-Antikörper-Subtyp-Magenkrebs-Screening-Bluttest-Kit
- Wizbiotech
- WAS, UKCA
- China
Dieses Kit ist für den qualitativen In-vitro-Nachweis von Urease-Antikörpern, CagA-Antikörpern und VacA-Antikörpern gegen Helicobacter pylori in menschlichen Vollblut-, Serum- oder Plasmaproben geeignet und eignet sich zur Hilfsdiagnose von HP-Infektionen sowie zur Identifizierung des Typs mit Helicobacter pylori infizierter Patient.
Description
Helicobacter pylori can be divided into two types based on expression of CagA and VacA: type I is toxigenic strain (with expression of both CagA and VacA or any one of them), which's highly pathogenic and easy to cause gastric diseases; type II is atoxigenic HP (without expression of both CagA and VacA), which’s less toxic and normally doesn't have clinical symptom upon infection.
Benefits
Diagnostic value: The H. pylori antibody test helps healthcare providers to dignose which type of hp the patient infected. It provides important information for clinical decision-making, including treatment and management options.
Convenient: The H. pylori antibody subtype test only requires a single blood sample and is easy to perform, making it a convenient option for both patients and healthcare providers.
Product Specifications
Method | Fluorescence Immunochromatographic Assay |
Sample Type | Whole blood/Serum/Plasma |
| Time to Result | 15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months from date of manufacture |
Kit Size | 1/5/20/25 tests |
※ Refer to Package Insert for additional product information.
Product Performance
WIZ Results of Urease antibody | Test result of Reference reagent | Positive coincidence rate: 94.39% (95%C.I. 90.46%~96.76%) Negative coincidence rate: 99.32% (95%C.I. 96.28%~99.88%) Total coincidence rate: 96.41% (95%C.I. 93.95%~97.89%) | ||
| Positive | Negative | Total | ||
| Positive | 202 | 1 | 203 | |
| Negative | 12 | 147 | 159 | |
| Total | 214 | 148 | 362 | |
WIZ Results of CagA antibody | Test result of Reference reagent | Positive coincidence rate: 95.28% (95%C.I. 89.43%~97.97%) Negative coincidence rate: 97.66% (95%C.I. 94.98%~98.92%) Total coincidence rate: 96.96% (95%C.I. 94. 64%~98.29%) | ||
| Positive | Negative | Total | ||
| Positive | 101 | 6 | 107 | |
| Negative | 5 | 250 | 255 | |
| Total | 106 | 256 | 362 | |
WIZ Results of VacA antibody | Test result of Reference reagent | Positive coincidence rate: 94.23% (95%C.I. 87.98%~97.33%) Negative coincidence rate: 97.29% (95%C.I. 94.51%~98.68%) Total coincidence rate: 96.41% (95%C.I. 93.95%~97.89%) | ||
| Positive | Negative | Total | ||
| Positive | 98 | 7 | 105 | |
| Negative | 6 | 251 | 257 | |
| Total | 104 | 258 | 362 | |
Applications
Outpatient Emergency Laboratory
Clinical Departments
Community Hospital
Laboratory Departments
Health Management Center
Clinic
Certifications
