Intended Use - EKF Diagnostics Quo-Test A1C Test Kit Gebrauchsanleitung

Intended Use

The Quo-Test A1C Test is intended for the in vitro quantitative
determination of glycated hemoglobin (HbA1c) in whole blood
obtained from finger prick or from venous blood samples into EDTA
tubes.
The Quo-Test A1C Test is indicated in the management and
treatment of diabetes mellitus and for monitoring long term glycemic
control in patients diagnosed with diabetes. The Quo-Test Analyzer
and A1C Test are designed for professional use only.
Summary and Explanation of the
Quo-Test A1C Test
Human red blood cells (erythrocytes) are freely permeable to glucose
present in the surrounding liquid (plasma) of the blood.
During the lifetime of the erythrocytes (normally up to 120 days)
exposure to blood glucose results in binding of glucose to the
hemoglobin A molecule present in erythrocytes. This is referred to as
glycated hemoglobin (1) .
Chronic elevated blood glucose will result in tissue and organ
damage (2) .
Good control of blood glucose, evident as lower HbA1c values, has
been proven to result in delayed onset and slower progression of
these complications (2,3) .
Principle of the Test
The Quo-Test A1C Test Cartridge contains all of the reagents
required for the determination of glycated hemoglobin in whole blood.
The Quo-Test A1C Test combines the chemical binding of boronate
to glycated hemoglobin with the fluorescent quenching effect that this
causes on a fluorescent marker bound to the boronate molecule.
The sample is collected using the Blood Collector which is
subsequently placed into the Quo-Test A1C Test Cartridge.
The Test Cartridge is then placed in the Quo-Test Analyzer and the
door closed.
The analyzer automatically pushes a mixing bead containing the
fluorescent boronate conjugate into the buffer contained within the
cartridge and reconstitutes it.
The analyzer then pushes the sample contained on the Blood
Collector into the buffer and mixes it to release the hemoglobin from
the erythrocytes.
The total hemoglobin concentration is determined from the initial
decrease in the fluorescent signal.
The fluorescent boronate conjugate binds to the glycated hemoglobin
which is measured by monitoring a decrease in the fluorescence of
the active ingredient.
3 EN 3121-9101-0255_ML1_02.01_QT Test Kit - 05/2017