Enzymatic Hemoglobin A1c assay for the Atellica CH Analyzer
Diagnosing and monitoring diabetes using the new HbA1c assay

Enzymatic Hemoglobin A1c assay for the Atellica CH Analyzer
 
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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 Typewhole blood and hemolysate
Sample Volume4.5 µL
Detection CapabilityLoB: 3.11 %HbA1c
LoD: 3.53 %HbA1c
Lot Calibration Interval180 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