Specifications

1.     Intended Use

HbA1c Elution Buffer A, when used in conjunction with GSH-60 Automatic HPLC HbA1c Analyzer, is intended for in vitro diagnostic use for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood.

2.     Test Principle

High Performance Liquid Chromatography (HPLC) is applied. Based on the charge differences, this method separates HbF, HbA1c and total HbA1 by using the cation exchange column and three types of elution buffer with different salt concentrations. The percentage of HbA1c peak in relation to the total area is calculated as the HbA1c concentration (%).

 Performance

• Excellent precision: CV≤1.5%

• Broader test range: 2.8%~18.4%

• Report multiple glycation components to provide more comprehensive clinical reference

  
  

 Easy Maintenance

• Automated daily maintenance

• Power-saving auto Stand-by function

• Utilize 4~12 Mpa high pressure pump which offers steady output and minimizes pipe blockage

 High Efficiency

• Up to 60 tests per hour. STAT position supported.

• Direct whole blood testing

• Cap piercing and no sample pre-treatment

• 110 sample positions with automatic loading function.

• Automatic identification of sample tube type.

• Userfriendly 20° flippable touch screen

The American Diabetes Association (ADA) recommends

HbA1c Recommended Testing Frequency:

At least twice a year in patients with stable and satisfactorily controlled blood glucose

• For those with unsatisfactory blood glucose control and need to adjust their regimen, testing should be done once every 3 months or so

• For pregnant women with diabetes mellitus treated with insulin, a test once every 2 months is recommended.

• For women with diabetes who are planning to become pregnant, glycosylated hemoglobin should be measured once a month at the beginning;After the blood sugar control is satisfactory, the test can be changed to once every 6-8 weeks until conception.