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ultra²™ A1c 
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Diabetes mellitus is a chronic disease in which the body either does not produce enough, or does not properly respond to insulin. This leads to an increased concentration of glucose in the blood (hyperglycaemia)
We can define 3 types of Diabetes:

  • Type I: Insulin dependent
  • Type II: Non-Insulin dependent
  • Gestational diabetes: High blood sugar (glucose) levels during pregnancy

Globally, an estimated 246 million people are affected by diabetes mellitus, but almost the half haven’t been identify.
The WHO estimates that this number will increase up to 380 million by 2025.
Major drivers for growth

  • Ageing Population
  • Rapid Cultural Changes
  • Increase of the Urbanisation
  • Dietary Changes
  • Decrease of the Physical activity
  • Inheritable genes


 

 

 
 

Controlling diabetes involves procedures such as adhering to a strict diet, exercising regularly, taking medicines prescribe by the doctor properly, monitoring your glucose levels, consulting and following your physician recommendations.

Glycated haemoglobin (HbA1c) has a particular clinical interest in diabetes mellitus. Measurement of glycated haemoglobin is a clinically useful means of assessing glycemic control in diabetics.

Glycated haemoglobin values reflect blood glucose levels over the circulatory half-life of the erythrocyte and correlate significantly with mean blood glucose levels during that time.

Therefore, measurement of glycated haemoglobin provides a means, independent of multiple measurements such as patient records of self-monitored blood glucose, for assessing the overall efficacy of therapy.

It is recommended an HbA1c test 3 times per year minimum for monitoring the glycemic in diabetics.

There is significant evidence that maintaining good glycemic control has a positive impact on reducing the development of the long-term complications of diabetes.


 
Free from common interferences 

The ultra2- A1c combines the advantages of boronate affinity separation with the precision, convenience and automation of high-performance liquid chromatography.

Boronate affinity chromatography is free from common interferences such as haemoglobin variants, non-glycation modifications and storage-related hemichromes.  Boronate affinity chromatography requires no sample pretreatment to remove the labile component, since only stable (ketoamine-linked) GHb is retained by the boronate.

Compared to ion-exchange techniques, affinity separation is also less sensitive to quantitative errors caused by minor fluctuations in reagent pH and ionic strength.


 
 

The ultra2- A1c software is especially designed for GHb/HbA1c analysis, controls the four basic system operation functions of sample identification, instrument operation, calculation of results and printing (and storing) complete reports with the availability of reprinting batch summary reports and chromatograms from computer storage.

Specifications

Small sample volume required: whole blood or packed red blood cells from any type blood tube.

  • Automatic sampling and injection system.
  • Keyboard entry or barcode scanning of patient sample identification information.
  • Computer-controlled unattended operation.
  • Individual sample reports with MBG and area of peaks,  %GHb, %HbA1c (NGSP), mMol HbA1c / mol Hb (IFCC) and eAG (estimated average glucose).
  • Summary report of test results from each batch run.
  • Real-time display to monitor system operation.
  • Minimum readable division:  Area percent = 0.1%.
  • Sample capacity:  475 samples per batch using the 215 Liquid Handler.
  • Throughput rate: 2 minutes per injection.
  • FDA clearance and CE Marked.

 


 
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