Status™ H. pylori

Immunoassay for the qualitative detection of anti-helicobacter pylori antibody in human whole blood, serum or plasma. Status H. pylori qualitatively detects 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 BloodModerate - Serum/Plasma Certification FDA CPT Codes 86318QW - Whole Blood More Information Instructions of Use (IFU) Healthcare Provider