II. PRINCIPLES OF OPERATION
The Avie A1C test system utilizes immunochemistry and general chemistry to quantify %A1C levels
(glycated hemoglobin) in whole blood. The system consists of a small electronic instrument (Reader),
a single-use diluent solution vial, and single-use reagent test cartridge.
To perform one test, the Reader is turned on. When the LCD display denotes “Ready” a test cartridge
is inserted into an unambiguous slot in the reader. A small amount of whole blood is added to the
diluent vial. This blood is immediately lysed and the hemoglobin is converted to met-hemoglobin.
At the instruction of the reader (LCD display), three drops of diluted blood are applied to the well on
the cartridge. The reactions then proceed automatically and no procedural steps are required. The test
is complete is less than 4 minutes.
The A1C test consists of two distinct quantitative areas of measurement. The first area consists of a
chamber where the met-hemoglobin is photometrical read at 420 nm. The optical density of the met-
hemoglobin is proportional to the concentration of total hemoglobin. The second area consists of a
mixing chamber where the diluted blood is mixed with anti hemoglobin antibodies conjugated to blue
microparticles. After a predetermined time the microparticle mixture is automatically released onto a
reagent strip where the reacted and unreacted microparticle species are separated and read optically.
The concentration of these species is used to calculate the amount of A1c. The final displayed result is
expressed as;
%A1C = (A1C ÷ TOTAL HB) ×100
If attached to an ancillary printer, the test results will be automatically printed out at the end of the test.
1.3
Avie
™
A1c Reader
Study the following illustrations to become familiar with the major components of your
Avie
™
A1c Reader:
