Tina-quant® HbA1c Gen. 3

Efficient diagnosis and monitoring of diabetes

  • HbA1c is viewed as a significant and accepted diabetic marker
  • In 2009 an international expert committee recommended HbA1c as a test to diagnose type 2 diabetes and prediabetes
  • The Tina-quant® HbA1c assay is a test that can be used to diagnose diabetes, identify people at risk of developing the disease and ongoing monitoring
  • Due to the high specificity of the reagent, this test is not affected by interferences from common hemoglobin variants such as HbS, HbE, HbC, and HbD
  • It delivers accurate results to enable effective management of patients

  • Whole blood and hemolysate application
  • Dual reporting in mmol/mol and %
  • Intermediate precision (CV) <1.5 %
  • Highly specific antibody
  • Reagent lot specific calibration
  • NGSP certified and traceable to the IFCC and DCCT reference method
  • Twin test reaction technology:
    The Twin Test reaction mode allows sequential measurement of the Hb and HbA1c in a single cuvette. Thus only one sample pipetting step is required with the positive effect of minimizing errors, improved precision and faster sample turnaround time.​ (fig.1)

Assay time 10 min
Sample material Anticoagulated venous or capillary blood or hemolysate
Acceptable anticoagulants: Li-, Na-heparin, K2-EDTA, K3-EDTA, Fluoride/Na2-EDTA, and Fluoride/K-oxalate
Sample volume 2 µL (whole blood)
Measuring range Hemoglobin: 2.48 - 24.8 mmol/L (4 - 40 g/dL);
HbA1c: typically 0.186 - 1.61 mmol/L (0.3 - 2.6 g/dL)
Repeatability Whole blood application: 1.6% [5.6% HbA1c]
Hemolysate application: 1.2% [5.6% HbA1c]
Whole blood application: 1.0% [8.0% HbA1c]
Hemolysate application: 1.0% [8.2% HbA1c]
Throughput 10 min to first result, subsequently 1 result every 24 seconds
Expected values According to IFCC: 29 - 42 mmol/mol HbA1c
According to DCCT/NGSP: 4.8 - 5.9% HbA1c
Analytical specificity
(whole blood and hemolysate)
Hb derivatives: Labile HbA1c (pre-HbA1c), acetylated Hb, and carbamylated Hb do not affect the assay results
Hb variants: Specimens containing high amounts of HbF (> 10%) may yield lower than expected HbA1c results
The assay is not affected by HbAS, HbAC, HbAE and HbAD traits

Fast and precise measurement for comprehensive care of diabetes patients

Clinical benefit

  • One test to diagnose diabetes, identify people at risk of developing the disease and provide ongoing monitoring
  • Reliable diabetes management with excellent precision and accuracy

Benefits for the lab

  • Uncompromised performance with no interference from HbAS, HbAD, HbAC and HbAE or acetylated, carbamylated Hb and labile HbA1c
  • Easy integration into routine testing without post-analytical data review (e.g. interpretation of chromatograms) delivers efficiency, cost and workflow improvements

Evidence suggests that a high number of patients are undiagnosed or do not achieve recommended blood glucose targets resulting in an increased risk of complications with diabetes. HbA1c has recently been recommended for the diagnosis of diabetes by the ADA.

A true result the first time, every time

Today, more than 80 million HbA1c tests per year are performed on cobas® and COBAS INTEGRA® platforms. Vulnerability to hemoglobin variants can lead to inaccurate result reporting for certain HbA1c measurement methods. Due to the high specificity of the antibody, Tina-quant® HbA1c measurement is unaffected by most hemoglobin variants.