- Overview
- Product Description
- Product Features
Basic Info.
Product Description
The H. Pylori Antigen Rapid Test(Feces) is a non-invasive lateralflow assay,rapid, precise and easy to perform. This test makes useof specific antibodies against H. Pylori antigen adsorbed onto a reactivemembrane. If H. Pylori is present in stool specimen, the specific antigenis bound by the second antibody which is conjugated with colloidal goldparticles.
A generic antibody, fixed onto the reactive membrane, in shape of theband, is able to capture the second conjugated antibody, assuring thecorrectness of the test performance.
Principle:Chromatographic Immunoassay
Format:Cassette
Package specifications:1 test/pack,25 tests/pack
Sample Type:Oropharyngeal/Nasopharyngea
Operation Temperature:15-30ºC
StorageTemperature:2-30ºC
Test Time:10 mins
Shelf Life:24 months
Clinical validation
| Product | Urea breath test | |||||
| Negetive | Positive | |||||
| H.Pylori Antibody Rapid Test | Negative | 167 | 2 | |||
| Positive | 1 | 135 | ||||
| Relative Sensitivity | 99.40%,95%CI(96.73%~99.98%) | |||||
| Relative Specificity | 98.54%,95%CI(94.83%~99.82%) | |||||
| Overall Agreement | 99.02%,95%CI(97.15%~99.80%) | |||||
Specification
| Principle | Chromatographic Immunoassay | Operation Temperature | 15-30ºC |
| Format | Cassette | Storage Temperature | 2-30ºC |
| Certificate | CE | Test Time | 10 min |
| Package specifications | 1 test/pack, 25 tests/pack | Shelf Life | 24 months |
| Sample Type | Feces |
Test procedure steps
Specimen collection and pre-treatment
1.Unscrew and remove the dilution tube applicator.Be careful not to sill or spatter solution from the tube.Colect specimens by insertingthe applicator stick into at least 3 different sites of the feces.
2.Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
3.Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.Specimens prepared in the specimencollection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.
4.Using a piece oftissue paper,break the tip of the diltution tube.Hald the tube verticaly, add 3 drops of sample to the sample application area.
5.Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.