Siemens Healthineers NEW A1c on Atellica CH, Dimension Vista, ADVIA Chemistry, and Dimension Analyzers

Aid in diagnosis and monitoring for diabetes patients, and help to confidently identify those at risk.

Diabetes is a growing problem. Over 30.2 million adults in the US 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).

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Assay Overview

Diagnose, monitor, and aid in identification of diabetes with our A1c assays:

  • Our A1c assays provide confidence in results with NGSP certified assays, IFCC traceable A1c assays, and meets the new 2020 CAP grading criteria.
  • Offers high precision and accuracy that meets new standards in A1c testing.
  • Demonstrates a < 5% change with most known HbA1c variants (HbC, HbD, HbE, HbS, and HbA2)
  • Good precision across the analytical measuring range (≤2% CV %HbA1c)

Siemens Healthineers is proud to offer new Hemoglobin A1c assays on Atellica CH, Dimension Vista, ADVIA Chemistry, and Dimension analyzers to meet the increasing demand for HbA1c testing. Developed to measure HbA1c as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus.

Assay Specifications


 

Atellica CH Enzymatic A1c_E

Dimension Vista A1C

Dimension ExL/RxL/Xpand A1C

ADVIA Chemistry Enzymatic A1c_E

Sample Type

Whole blood and hemolysate

Whole blood

Whole blood

Whole blood and hemolysate

Sample Volume

4.5 µL

8 μL

3μL

4.5μL

Detection Capability

LoB: 3.11 %HbA1c
LoD: 3.53 %HbA1c

LoB: 3.5% HbA1c
LoD: 3.7% HbA1c

LoB: 3.6% HbA1c
LoD: 3.7% HbA1c

LoB: 3.18% HbA1c
LoD: 3.60% HbA1c

Calibration Interval

180 Days(Lot Cal)
63 Days(Pack Cal)

30 Days

30 Days

31 Days (large kit)
51 Days (small kit)

Reagent Onboard Stability

63 Days

30 Days

30 Days

31 Days (large kit) 51 Days (small)

Time to First Result

10 minutes

14.3 minutes

8.8 minutes

10 minutes

Measuring Interval

3.8-14.0% HbA1c
(18.03-129.50 mmol/mol HbA1c)

3.8-14.0% HbA1c
(18.0-130.0 mmol/mol HbA1c)

3.8-14.0% HbA1c
(18.0-130.0 mmol/mol HbA1c)

3.8-14.0% HbA1c
(18.03-129.50 mmol/mol HbA1c)

Complete the form below to download our guide to the new 2020 CAP grading criteria for HbA1c diagnostic assays

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