H. pylori Ag Rapid Test CE
The OnSite H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection of H. pylori antigen in human fecal specimen. It is a noninvasive diagnostic method and can be performed within 10 minutes by minimally skilled personnel, and without the use of laboratory equipment.
This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with H. pylori.
The OnSite H. pylori Ag Rapid Test detects antigen present in the feces by using specific antibodies, which indicates an active H. pylori infection. However, a negative test result does not preclude the possibility of infection with H. pylori. It can also be used to monitor the effectiveness of treatment and the recurrence of an infection, and is not affected by the use of Proton Pump Inhibitors (PPI). It is reported that the seroprevalence of H. pylori in specimens with positive fecal occult blood (FOB) test results is approximately 39.3%. Therefore a specimen that tests positive with an FOB test may also be tested positive with the OnSite H. pylori Ag Rapid Test. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.
- Clinical accuracy: 96.7% sensitivity, 93.8% specificity
- Analytical sensitivity: 100% positive detection rate at 1 ng/mL of pylori lysate antigen in fecal specimens
- Cross reactivity: no cross reactivity with the following organisms at ≥ 1 x 108 org/mL: Acinetobacter calcoaceticus, Neisseria gonorrheae, Adenovirus, Neisseria meningitides, Enterococcus faecalis, Proteus mirabilis, Escherichia coli, Proteus vulgaris Hauser, Gardnerella vaginalis, Pseudomonas aeruginosa, Geotrichum candidum, Rotavirus, Haemophilus influenza, Salmonella Paratyphi A, α-haemolytics streptococcus, Salmonella Paratyphi B, β-haemolytic streptococcus, Salmonella Paratyphi C, Klebsiella pneumonia, Salmonella typhi, Moraxella catarrhalis
- Interference: No interference was seen 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
- Shelf life: 24 month
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Stool collection devices, each containing 2 mL extraction buffer
- Plastic droppers for transferring watery stool
- Package insert (instruction for use)