H.Pylori
Intended Use:
The H. Pylori Ab Rapid Test is a lateral flow immunoassay detecting IgG, IgM, and IgA antibodies against Helicobacter pylori in human serum, plasma.
Principle:
The H. Pylori Ab Rapid Test employs a double antigen–sandwich technique, featuring a conjugate pad with H. Pylori antigens, a nitrocellulose membrane with T and C bands, and gold-conjugated components. When the test specimen is applied, capillary action facilitates migration, leading to antibody binding to H. Pylori conjugates. A burgundy T band confirms a positive result, while its absence indicates negativity. The internal control (C band) ensures validity, with an invalid result prompting retesting with a new device.
Testing Procedure
Importance to know
Warnings and Precautions
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Please read the instruction carefully before performing the test.
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Do not use the test after the expiration date.
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Immediately carry out the test after removing the test device from the pouch.
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Do not mix or interchange the specimen sample.
Limitation
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Follow the Assay Procedure and Interpretation closely to avoid inaccurate results when testing for H. Pylori antibodies.
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The H. Pylori Ab Rapid Test detects qualitative IgG, IgM, and IgA antibodies; test band intensity doesn't correlate linearly with antibody titer.
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A negative result suggests no detectable antibodies, but exposure or infection cannot be ruled out.
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Negativity may occur if antibody levels are below detection limits or not present during the sampled disease stage.
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Specimens with high heterophile antibodies or rheumatoid factor may impact results.
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Interpret results alongside other diagnostic methods and clinical findings for accuracy.
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