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.