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The H. pylori Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM, and IgA) anti-Helicobacter pylori (H.pylori) in human whole blood, serum, or plasma and H. pylori antigen in feces.
Gastritis and peptic ulcers are one of the most common human diseases. Since the discovery of H. pylori, many reports have suggested that this organism is one of the main causes of ulcer diseases and stomach cancer. The eradication of H. pylori has been associated with the elimination of ulcer diseases. The detection of the specific IgG antibodies to H. pylori has been shown to be an accurate method for the detection of H. pylori infection in symptomatic patients.
STORAGE AND STABILITY
All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test is not stable out of the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.
TEST PROCEDURE
1. Remove the test device from its foil pouch by tearing along the notch and use it as soon as possible.
2. Specimen collection. See also specimen collection.
3. Holding the sample collection device upright, carefully break off the tip of the collection device.
4. Squeeze 2 drops (~80μL) of the sample solution in the sample well of the cassette, as in the illustration.
5. Read the test results in 10 minutes. It is important that the background is clear before the result is read. Do not read results after 10 minutes. To avoid confusion, discard the test device after interpreting the result.
INTERPRETATION OF RESULTS
Positive: Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
Negative: One colored line appears in the control line region(C). No line appears in the test line region (T).
Invalid: Control line fails to appear.
Ordering Information
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