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H. pylori Ag Rapid Test CE / REF: R0192C

H. pylori Ag Rapid Test CE / REF: R0192C

H. pylori Ag Rapid Test CE / REF: R0192C

Description:

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.

  • 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 faecalisProteus mirabilis, Escherichia coli, Proteus vulgaris Hauser, Gardnerella vaginalisPseudomonas 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
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