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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.
Each kit contains:
40 EZER™ H. pylori Antibody test cassettes
40 Sterile plastic droppers
1 Sample buffer vial
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).
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:
Supports diagnosis of gastritis and peptic ulcer disease
Reduces the need for endoscopic biopsy
Enables accessible screening in outpatient and primary care settings
Assists clinical decision-making when combined with symptoms and history
Because antibodies may persist after infection, results should be interpreted alongside other clinical findings.
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:
Sensitivity: 97.9%
Specificity: 97.4%
Overall Agreement: 97.6%
Time to Result: 15 minutes
No cross-reactivity observed with:
Influenza A/B
RSV
Adenovirus
HIV, HCV, HBV
Syphilis
Sample Types:
Whole blood (EDTA, citrate, heparin)
Serum or plasma
Test Procedure:
Bring test device and sample to room temperature
Add specimen to the sample well
Add 2 drops of buffer
Read results after 15 minutes
Result Interpretation:
Positive: Two colored lines (C and T)
Negative: One colored line (C only)
Invalid: No control line visible
The simple workflow and visual readout make this test suitable for routine clinical use and point-of-care diagnostics.
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