The OnSite H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection of H. pylori antigen in human faecal specimens. It is a non-invasive diagnostic method and can be performed within 10 minutes by minimally skilled personnel 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 antigens present in the faeces 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 it is not affected by the use of Proton Pump Inhibitors (PPI). It is reported that the seroprevalence of H. pylori in specimens with positive faecal occult blood (FOB) test results is approximately 39.3%. Therefore, a specimen that tests positive with a FOB test may also test 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.

Product Features

Clinical accuracy: 7% sensitivity, 93.8% specificity
Analytical sensitivity: 100% positive detection rate at 1 ng/mL of pylori lysate antigen in faecal specimens
Cross-reactivity: no cross-reactivity with the following organisms at ≥ 1 x 10⁸ org/mL: Acinetobacter calcoaceticus, Neisseria gonorrhoea, 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-haemolytic streptococcus, Salmonella Paratyphi B, β-haemolytic streptococcus, Salmonella Paratyphi C, Klebsiella pneumonia, Salmonella typhi, and 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 months