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Afinion™ HbA1c Dx

Diagnosis in Minutes.

Introducing the first-ever HbA1c test cleared for diagnosis at the POC.

Finally — an HbA1c test that can be used as an aid to diagnose and monitor your patients with diabetes or pre-diabetes at the point of care in just 3 minutes.

Diagnosing patients with diabetes just got a lot easier with the Afinion™ HbA1c Dx for use on the Afinion Analyzer. 

Benefits

Short assay time in 3 minutes

The Afinion™ HbA1c Dx test is run on the market-leading Afinion platform. It has no interference from common Hb variants and is NGSP and IFCC certified.

Timely Treatment Changes at the Point of Care

Diabetes can be treated and managed by healthful eating, regular physical activity, and medications to lower blood glucose levels. Lowering the HbA1c has been shown to reduce microvascular complications of diabetes and, if implemented soon after the diagnosis of diabetes, is associated with long-term reduction in macrovascular disease.1-2

The Afinion™ HbA1c Dx assay is an in vitro diagnostic test for quantitative determination of HbA1c in human venous and capillary whole blood. The test provides unquestionably accurate results in only 3 minutes and can lead to better patient outcomes and clinic efficiencies.3,4,5

Long shelf life of reagents

Patient consultations can be carried out with confidence. The Afinion™ HbA1c Dx Test Cartridge contains all reagents necessary for the measurement of glycated hemoglobin with 3 months room temperature storage.

Helpful Documents
  • Sample volume: 1.5 µL
  • Assay time: 3 minutes
  • Measuring range: 4.00 -15.00% HbA1c
  • Traceable to the IFCC Reference Method    
  • NGSP and IFCC certified
  • No influence from common Hb variants like HbC, HbD, HbE and HbS
  • Afinion™ HbA1c Control: 2 levels, ready to use
  • Afinion™ HbA1c Calibration Verification: 3 levels, ready to use
  • Sample material: Capillary blood or anticoagulated venous blood (EDTA)
Afinion™ Test System Code
Afinion™ HbA1c Dx
 1116794
Afinion™ HbA1c Control 1116975
Afinion™ HbA1c Calibration Verification
 1116792
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  1. Diabetes C, Complications Trial Research G, Nathan DM, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
  2. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577-89.
  3. Swensen MH, et al. Evaluation of the Alere Afinion HbA1c Dx Test: Can Point of Care HbA1c Testing Deliver the Performance Needed for Diagnostic Use? American Diabetes Association’s 76th Scientific Sessions; June 10-14, 2016; New Orleans, LA.
  4. Rio Grande case study: https://www.brookings.edu/wp-content/uploads/2016/06/Rio-Valley-ACO.pdf
  5. Patzer KH et. al. J Diab Sci Technol. 2018 May;12(3):687-694 study

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This website is governed by applicable U.S. laws and governmental regulations. The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. Not all products are available in all regions. Check with your local representative for availability in specific markets. For In Vitro Diagnostic Use Only. For the use of registered medical practitioners, hospitals and Laboratories only.

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