Individually sealed foil pouch, containing
test cassette and sample diluent
Stool collection device, containing sample
extraction buffer
Now including external controls to facilitate
internal laboratory quality control!
OnSite
®
H. pylori Ag Rapid Test
Cat. # R0192C
The OnSite® H. pylori Ag Rapid Testis a lateral flow chromatographic immunoassay for the qualitative detection of H. pylori antigen in human fecal specimens. This antigen detection test is a noninvasive diagnostic method and can be performed within 10 minutes.
The OnSite® H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of H. pylori antigen in human fecal specimens. This antigen detection test is a noninvasive diagnostic method and can be performed within 10 minutes.
Product Features
- Easy-to-collect specimen type
- External controls facilitate internal laboratory quality control
- Results in only 10 minutes
- No equipment required
- Shelf Life: 24 months
- Storage Temperature: 2-30°C
Clinical Performance
- Positive Percent Agreement (PPA; Relative Sensitivity): 100% (95% CI: 92.0%-100%)
- Negative Percent Agreement (NPA; Relative Specificity): 98.5% (95% CI: 94.8-99.6%)
- No cross-reactivity to 50+ gastrointestinal pathogens
- No interference was observed with 5 mg/mL Tums® Antacid, 1:20 Pepto-Bismol® Antacid, 5 mg/mL Tagamet® Antacid, 5% Barium sulfate, 5 mg/mL Prilosec® Antacid, 12.5% Hemoglobin (tarry stool), or 1:20 Mylanta® Antacid.
Please contact tech@ctkbiotech.com for further details about pathogens and substances tested for cross-reactivity/interference.
Support
- Instructions for Use: Revision G1.1
- Flyer
ORDERING INFORMATION
| Catalog # | Product | Quantity | Specimen |
|---|---|---|---|
| R0192C-10T | OnSite H. pylori Ag Rapid Test CE | 10 T/Kit | Fecal |
| R0192C-20T | OnSite H. pylori Ag Rapid Test CE | 20 T/Kit | Fecal |
| R0192C | OnSite H. pylori Ag Rapid Test CE | 25 T/Kit | Fecal |
| R0192C-30T | OnSite H. pylori Ag Rapid Test CE | 30 T/Kit | Fecal |
| R0192C-50T | OnSite H. pylori Ag Rapid Test CE | 50 T/Kit | Fecal |
Product Features
- Easy-to-collect specimen type
- External controls facilitate internal laboratory quality control
- Results in only 10 minutes
- No equipment required
- Shelf Life: 24 months
- Storage Temperature: 2-30°C
Clinical Performance
- Positive Percent Agreement (PPA; Relative Sensitivity): 100% (95% CI: 92.0%-100%)
- Negative Percent Agreement (NPA; Relative Specificity): 98.5% (95% CI: 94.8-99.6%)
- No cross-reactivity to 50+ gastrointestinal pathogens
- No interference was observed with 5 mg/mL Tums® Antacid, 1:20 Pepto-Bismol® Antacid, 5 mg/mL Tagamet® Antacid, 5% Barium sulfate, 5 mg/mL Prilosec® Antacid, 12.5% Hemoglobin (tarry stool), or 1:20 Mylanta® Antacid.
Please contact tech@ctkbiotech.com for further details about pathogens and substances tested for cross-reactivity/interference.
Support
- Instructions for Use: Revision G1.1
- Flyer
ORDERING INFORMATION
| Catalog # | Product | Quantity | Specimen |
|---|---|---|---|
| R0192C-10T | OnSite H. pylori Ag Rapid Test CE | 10 T/Kit | Fecal |
| R0192C-20T | OnSite H. pylori Ag Rapid Test CE | 20 T/Kit | Fecal |
| R0192C | OnSite H. pylori Ag Rapid Test CE | 25 T/Kit | Fecal |
| R0192C-30T | OnSite H. pylori Ag Rapid Test CE | 30 T/Kit | Fecal |
| R0192C-50T | OnSite H. pylori Ag Rapid Test CE | 50 T/Kit | Fecal |
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