One Step H. Pylori Feces Test is intended for use by healthcare professionals and as qualitative screening in vitro diagnostic test for detection of H.Pylori antigen in feces, as an aid in the diagnosis of H.Pylori infection. This test is not automated and does not require any additional instrument.
Cat. No: HP-A01
Benefits
Fast：Instant results within 15 minutesConvenient: Room temperature storage (2-30℃) , valid for 24 months
Easy to Use: No equipment is required to process the specimens or read the results
Non-Invasive Sampling: Whole Blood/Serum/Plasma
H Pylori Antigen Rapid Test Cassette Helicobacter Pylori Antigen Rapid Stool Test
Description
| Storage: | 2℃-30℃ | Sample Type: | Feces |
|---|---|---|---|
| User: | Professional | Accuracy: | 95% |
| Certificate: | CE ISO 13485 | OEM: | OEM Customized Packing Avaliable |
| Formats: | 25T/box 1T/box | After-sales Service: | Available |
| Key Words: | Infection Disease H.Pylori Antigen Rapid Test With CE Certificate | For The Crowd: | Preliminary Screening Of Infected People |
| High Light: | H Pylori Antigen Rapid Test Cassettehelicobacter pylori antigen rapid stool testh pylori rapid stool test | ||
Infection Disease H.Pylori antigen Rapid Test with CE certificate
| Product Name | Infection Disease H.Pylori antigen Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Feces |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| 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
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 | |||
Storage
1.Store at 4~30℃ in the sealed pouch up to the expiration date printed on the package. Do not freeze.
2.The test cassette/strip should be used within 1 hour after taking out from the sealed pouch.
3.Keep away from sunlight, moisture and heat.
4.The manufacturing date is printed on the outer box.