H. pylori Ag Rapid Test CE

Features:

• 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)