CTK Biotech, USA H. Pylori Ag Rapid 25 Test

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  This product features: Stool collection device minimizes handling of fecal specimen

• 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, ?-haemolytics streptococcus, Salmonella Paratyphi B, ?-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

Each kit contains:

• 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)

TEST PRINCIPLE : The OnSite H. pylori Ag Rapid Test is lateral flow chromatographic immunoassay. The test strip in the cassette device consists of: 1) a burgundy colored conjugate pad containing anti-H.pylori specific antibody conjugated with colloidal gold (anti-H. pylori conjugate) and 2) a nitrocellulose membrane strip containing a test line (T line) and a control  line (C  line). The T line is pre-coated with anti-H. pylori antibody, and the C line is precoated with a control line antibody.     When an adequate volume of extracted fecal specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. The H. pylori antigen, if present in the specimen, will bind to the anti-H. pylori conjugate. The immunocomplex is then captured on the membrane by the pre-coated antibody forming a burgundy colored T line, indicating an H. pylori Ag Rapid Test positive result.   Absence of the T line suggests an H. pylori Ag Rapid Test negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies regardless of the color development on the T line. If no control line (C line) develops, the test result is invalid and the specimen must be retested with another device