Principle
Concentration in whole blood. Total hemoglobin & HbA1c have the same specific absorption rate to latex particles. When mouse anti human HoA 1c monoclonal antibody is added, latex-+IbA1c-mouse anti human HbA1c antibody complex is formed. Agglutination is formed when a goat anti-mouse IgG polyclonal antibody interacts with a monoclonal antibody. The amount of agglutination is proportional to the concentration of HA 1c in the specimen and is measured phototactically.
Procedure
Whenever the reagent lot is changed.
As per the requirement of quality control procedures.
Reaction Type……………End Point
Reaction direction…………… Increasing
Wavelength…………….650 nm
Flow Cell temperature…………… 37°C
Zero Setting with…………… Reagent Blank
Sample Volume…………… 10 pl
Reagent 1 (R1) volume………….. 360 pl
Reagent 2 (R2) volume……………120 pl
Linearity…………. 16%
Quality Control
To ensure adequate quality control, it is recommended that
each laboratory should use a normal and an abnormal
commercial reference control material. It should be realized
that the use of quality control material checks both reagent
and instrument functions together. Factors which might affect
the performance of this test include instrument function,
temperature control, cleanliness of glasswares and accuracy
of pipetting.
Other Details
Stable till expiry date indicated on the label when stored at 2°C -8°C
Sonal Mitale –
innovative and indigenous products with good quality in house reagents…