Rapid Gastrointestinal Tests

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The OnSite H. pylori Ab Combo Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies  (IgG, IgM and IgA) against Helicobacter pylori (H. pylori) in human serum, plasma or whole blood.

Features:

• No need to avoid certain medications
• Non-invasive, easy to perform procedure
• Package insert (instruction for use)

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The OnSite S. Typhi/Paratyphi Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Salmonella typhi (S. typhi) and Salmonella paratyphi (S. paratyphi) antigens in a human fecal specimen, serum, plasma, whole blood and blood culture specimen.

Features:

• Detects the specific antigens from either S. typhi or S. paratyphi
• Earlier detection results in faster treatment for disease eradication
• Works with a variety of specimen types including: fecal, serum, plasma, whole blood, and blood culture
• Simple procedure minimizes operator error due to sample preparation
• High level of reproducibility
• Test kits can be used and stored at room temperature
• Patient ID stickers
• One package insert (instruction for use)

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The OnSite Rotavirus Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of rotavirus antigen in fecal specimens.

Features:

• Stool collection device minimizes sample handling
• Utilizes a pair of specific antibodies to detect rotavirus antigen
• Detects Group A rotavirus
• No cross-reactivity with other gastrointestinal infectious diseases
• Stool collection devices, each containing 2 mL extraction buffer
• Plastic droppers (for transferring watery stool)
• Patient ID stickers
• Package insert (instruction for use)

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The OnSite Rota/Adeno Ag Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of rotavirus and adenovirus antigens in fecal specimens.

Features:

• Individually sealed foil pouches containing: One dip strip device, One desiccant
• Stool collection device minimizes sample handling
• Time saving differentiation between rotavrus and adenovirus in a single test
• No cross-reactivity with other gastrointestinal infectious diseases
• Plastic droppers (for transferring watery stool)
• Patient ID stickers
• Package insert (instruction for use)

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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). 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.

Features:

• Stool collection devices, each containing 2 mL extraction buffer
• Plastic droppers for transferring watery stool
• Package insert (instruction for use)
• 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