- For qualitative detection of H. pylori antibodies in whole blood, serum or plasma.
- Kit contains 25 test devices, 25 capillary tubes, developer solution and instructional insert.
- Results in 10 minutes or less; 95.9% sensitivity vs biopsy/histology.
- CLIA-waived (whole blood) for point-of-care use; easy visual read.
- SKU:
- 704522
- Contents:
- (25) Test Devices, (25) Capillary Tubes, Developer Solution, Directional Insert
- QTY Per Sell:
- 1
- Number of Tests:
- 25 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Whole Blood / Serum / Plasma Sample
- Technical Specifications:
- Time to result: 10 minutes
- Sensitivity: 95.9% vs biopsy/histology
- Format: cassette, solid-phase immunoassay
- Regulatory Information:
- CLIA waived for whole blood
- Moderate complexity for serum/plasma
- Storage Instructions:
- Store at controlled room temperature (per IFU); avoid freezing
- Test Format:
- Cassette format; indirect solid-phase immunoassay
- CPT Codes:
- Whole blood: 86318QW
- Serum/plasma: 86677
- Manufacturer Links:
- Sekisui Diagnostics product page for OSOM H. pylori
- Country of Origin:
- Made in the USA
- CLIA Classification:
- Whole blood: CLIA Waived
- Serum/plasma: Moderate complexity
- Time to Results:
- 10 minutes or less
- SKU:
- 704522
- Contents:
- (25) Test Devices, (25) Capillary Tubes, Developer Solution, Directional Insert
- QTY Per Sell:
- 1
- Number of Tests:
- 25 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Whole Blood / Serum / Plasma Sample
- ic__sync_id:
- 4
- ic__id:
- 7885
- Technical Specifications:
- Time to result: 10 minutes
- Sensitivity: 95.9% vs biopsy/histology
- Format: cassette, solid-phase immunoassay
- Regulatory Information:
- CLIA waived for whole blood
- Moderate complexity for serum/plasma
- Storage Instructions:
- Store at controlled room temperature (per IFU); avoid freezing
- Test Format:
- Cassette format; indirect solid-phase immunoassay
- CPT Codes:
- Whole blood: 86318QW
- Serum/plasma: 86677
- Manufacturer Links:
- Sekisui Diagnostics product page for OSOM H. pylori
- Country of Origin:
- Made in the USA
- CLIA Classification:
- Whole blood: CLIA Waived
- Serum/plasma: Moderate complexity
- Time to Results:
- 10 minutes or less