- Medex SKU:
- ADE-AFINION2A1C
- Packing Info:
- 1/Each
- Usually Ships:
- 2 - 4 Weeks
Description
Test Turnaround: Delivers quantitative HbA1c results in approximately 3 minutes.
Sample Volume: Requires a micro-sample of $1.5\ \mu\text{L}$ of whole blood.
Sample Types: Accepts capillary fingerstick blood or anticoagulated venous blood (EDTA, heparin, or citrate).
Cartridge Design: All-in-one disposable cartridge containing an integrated capillary collection device and pre-filled reagents.
Testing Methodology: Utilizes boronate affinity separation, preventing interference from common hemoglobin variants (HbS, HbC, HbD, HbE).
Measurement Range: Analyzes HbA1c values from 4.0% to 15.0%.
Calibration & Quality Checks: Factory-calibrated with automatic lot-specific data entry via barcode scanning and automated optical fail-safe checks.
Regulatory Classification: CLIA-waived for point-of-care clinical use.
Reagent Storage: Stable refrigerated ($2\text{–}8^\circ\text{C}$) through expiration, or at room temperature ($15\text{–}25^\circ\text{C}$) for up to 90 days.