H. pylori Antibody Rapid Test – EZER™
The EZER™ H. pylori Antibody Combo Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of antibodies to Helicobacter pylori in human whole blood, serum, or plasma. This test supports non-invasive diagnosis by identifying immune responses to H. pylori, eliminating the need for endoscopic biopsy or radioactive testing methods. Delivering results within 15 minutes, the test demonstrates an overall agreement of 97.6% when compared with commercial PCR methods. It is designed for professional in vitro diagnostic use and is well suited for routine screening in gastroenterology clinics and diagnostic laboratories. The cassette-based format enables straightforward operation, with results displayed through a visible control (C) line and test (T) line. A positive result reflects the presence of H. pylori antibodies, assisting clinicians in evaluating patients with suspected H. pylori-related gastrointestinal disease. The test combines ease of use with strong analytical performance, making it ideal for decentralized and high-throughput testing environments.
Quote-based, no public pricing. Add to your quote and our specialists put together a proposal with the right documentation, typically within 24 hours.
This kit in detail
The EZER™ H. pylori Antibody Combo Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of antibodies to Helicobacter pylori in human whole blood, serum, or plasma. This test supports non-invasive diagnosis by identifying immune responses to H. pylori, eliminating the need for endoscopic biopsy or radioactive testing methods.
Delivering results within 15 minutes, the test demonstrates an overall agreement of 97.6% when compared with commercial PCR methods. It is designed for professional in vitro diagnostic use and is well suited for routine screening in gastroenterology clinics and diagnostic laboratories. The cassette-based format enables straightforward operation, with results displayed through a visible control (C) line and test (T) line. A positive result reflects the presence of H. pylori antibodies, assisting clinicians in evaluating patients with suspected H. pylori-related gastrointestinal disease. The test combines ease of use with strong analytical performance, making it ideal for decentralized and high-throughput testing environments.
- H. pylori antibody detection – Identifies immune response to Helicobacter pylori
- Rapid results – Clear visual readout in 15 minutes
- High accuracy – 97.9% sensitivity and 97.4% specificity
- Flexible sample types – Compatible with whole blood, serum, or plasm
What is in the H. pylori Antibody Rapid Test?
Each kit contains:
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40 EZER™ H. pylori Antibody test cassettes
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40 Sterile plastic droppers
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1 Sample buffer vial
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Package insert with detailed instructions for use
The test detects antibodies to H. pylori using immunochromatographic analysis. If H. pylori-specific antibodies are present in the sample, a red-purple line appears in the test region (T) in addition to the control line (C).
Role of H. pylori Antibodies in Disease
Helicobacter pylori infection triggers a humoral immune response, leading to the production of specific antibodies detectable in blood. Unlike antigen-based or invasive diagnostic methods, antibody testing offers a non-invasive approach to identifying infection. Detection of Helicobacter pylori antibodies:
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Supports diagnosis of gastritis and peptic ulcer disease
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Reduces the need for endoscopic biopsy
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Enables accessible screening in outpatient and primary care settings
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Assists clinical decision-making when combined with symptoms and history
Because antibodies may persist after infection, results should be interpreted alongside other clinical findings.
About the EZER™ H. pylori Antibody Rapid Test
This test is developed by Genesis Biotech and utilizes H. pylori antigens conjugated to colloidal gold particles, combined with immobilized anti-human antibodies for detection. An internal control line ensures test validity and proper sample migration.
Performance Summary:
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Sensitivity: 97.9%
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Specificity: 97.4%
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Overall Agreement: 97.6%
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Time to Result: 15 minutes
No cross-reactivity observed with:
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Influenza A/B
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RSV
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Adenovirus
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HIV, HCV, HBV
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Syphilis
Principle and Workflow
Sample Types:
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Whole blood (EDTA, citrate, heparin)
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Serum or plasma
Test Procedure:
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Bring test device and sample to room temperature
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Add specimen to the sample well
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Add 2 drops of buffer
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Read results after 15 minutes
Result Interpretation:
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Positive: Two colored lines (C and T)
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Negative: One colored line (C only)
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Invalid: No control line visible
The simple workflow and visual readout make this test suitable for routine clinical use and point-of-care diagnostics.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
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