Immunoassay for the qualitative detection of anti-helicobacter pylori antibody in human whole blood, serum or plasma.
Status H. pylori qualitatively detect anti-Helicobacter pylori antibody in human whole blood, serum, or plasma specimens. The test is intended for use as an aid in the diagnosis of H. pylori infection in adult patients with symptoms of gastrointestinal disorders.
Product Specifications
| Tests/Box | 30 |
| Sample type | Finger stick whole blood, serum or plasma specimen collection |
| Time to results | 10 minutes |
| Measures | 95.9% Sensitivity / 91.6% overall agreement to biopsy histology |
| Kit contents | (30) test devices, (30) capillary tubes, (1) dropper bottle of developer solution, Instructions for use, Procedure card |
| Storage | 35-86°F (2-30°C) |
| CLIA complexity | Waived - Whole Blood
Moderate - Serum/Plasma |
| Certification | FDA |
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