Intended Use
This reagent is intended for in vitro quantitative determination of HbA1c in human
blood.
-Nephelometry methodology
-Direct result in % HbA1c from analyzer
-No total Hb determination required
-No calibration required
-Linear up to 13%
-Lower Detection Limit of 3%
Clinical Significance
HbA1c is a glycated form of hemoglobin formed by the attachment of glucose
residues in the blood to the hemoglobin molecules. In the diabetic population
where blood glucose levels are abnormally elevated, the level of HbA1c also
increases. The level of HbA1c is proportional to the level of glucose in the blood
and has been widely accepted as an indicator of the mean blood glucose
concentration in the preceding 6-8 weeks. It is therefore a long-term indicator of
diabetic control. For routine use HbA1c levels should be monitored every 3-4
months.
Principle
The whole blood is lysed using haemolysing reagent. The lysed whole blood
containing HbA1c along with other haemoglobins compete to adsorb to the
unsensitised latex particles in the R1. A mouse antihuman HbA1c monoclonal
antibody is added into the reaction that specifically binds to the human HbA1c
molecules to form latex HbA1c- mouse antihuman HbA1c antibody complex.
Another antibody, goat anti mouse polyclonal antibody that react with the formed
complex to give agglutination. The amount of agglutination is proportional to the
amount of HbA1c adsorbed on to the surface of latex particles.