Enzymatic Hemoglobin A1c assay for the Atellica CH Analyzer
Diagnosing and monitoring diabetes using the new HbA1c assay
Diabetes is a growing global problem. Over 420 million adults globally have diabetes mellitus,1 a chronic disease caused by inadequate production of, or cellular sensitivity to, insulin, resulting in abnormally high blood glucose (hyperglycemia). Glycemic states can be measured by fasting blood glucose, fructosamine, or glycated hemoglobin (HbA1c). Siemens Healthineers is proud to offer the Enzymatic Hemoglobin A1c assay for the Atellica CH Analyzer to meet the increasing demand for HbA1c testing. It was developed to measure HbA1c for the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus and identification of those at risk for developing diabetes mellitus.
Features and Benefits:
- Provides confidence in results with a NGSP certified and IFCC standardized A1c assay
- Offers high precision and accuracy that meets new standards in A1c testing
- Demonstrates < 5% change with most known HbA1c variants (HbC, HbD, HbE, HbS, and HbA2)
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Assay Specifications
Enzymatic Hemoglobin A1c assay
| Sample Type | whole blood and hemolysate |
| Sample Volume | 4.5 µL |
| Detection Capability | LoB: 3.11 %HbA1c LoD: 3.53 %HbA1c |
| Lot Calibration Interval | 180 days |
| Pack Calibration Interval | 63 days |
| Reagent Onboard Stability | 63 days |
| Time to First Result | 10 minutes |
| Measuring Interval | 3.80–14.00 %HbA1c (18.03–129.50 mmol/mol) |
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1IDF Diabetes Atlas. 8th ed. 2017. Available from: https://www.idf.org/e-library/epidemiology-research/diabetes-atlas.html