Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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| Product Name |
Infection Disease H.Pylori antigen uncut sheet |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Feces |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The H. Pylori Ag Rapid Test Device (Feces) is a rapid chromatographic immunoassay for the qualitative detection of antigens to H. Pylori in feces to aid in the diagnosis of H. Pylori infection.
PERFORMANCE CHARACTERISTICS
Table: H. Pylori Ag Rapid Test vs. Biopsy/Histology/RUT
|
Relative Sensitivity: >95.0% (90.0%-97.9%)* Relative Specificity: >95.7% (92.3%-97.9%)* Overall Agreement: >95.4% (92.8%-97.3%)* *95% Confidence Interval |
H. Pylori Ag Rapid Test | ||||
| + | - | Total | |||
|
Biopsy/ Histology/ RUT |
+ | 131 | 7 | 138 | |
| - | 10 | 225 | 235 | ||
| 141 | 232 | 373 | |||
The H. Pylori Ag Rapid Test Device (Feces) is a non-invasive lateral flow assay, rapid, precise and easy to perform.
This test makes use of specific antibodies against H. Pylori antigen adsorbed onto a reactive membrane. If H. Pylori is present in stool specimen, the specific antigen is bound by the second antibody which is conjugated with colloidal gold particles. A generic antibody, fixed onto the reactive membrane, in shape of the band, is able to capture the second conjugated antibody, assuring the correctness of the test performance.