H Pylori Antibody Subtype Stomach Cancer Screening Blood Test Kit
- Wizbiotech
- CE,UKCA
- China
This kit is applicable to in vitro qualitative detection of Urease antibody, CagA antibody and VacA antibody to helicobacter pylori in human whole blood, serum or plasma sample, and it's suitable for auxiliary diagnosis of HP infection as well as identification of type of helicobacter pylori patient infected with.
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
