Clover A1c Self

Intended use

Clover A1c Self Analyser is an in vitro diagnostic instrument for measuring A1c hemoglobin by a well-established boronate affinity method. It can analyse samples of whole capillary blood or EDTA, venous blood treated with heparin. CLOVER A1c Self analyser is designed to support diabetes control. They are intended for use by patients, laboratory staff, clinics and hospitals.

Principles of operation

CLOVER A1c Self system uses reflection spectrometry, ie fully automated boronate affinity methods to determine the percentage of A1c hemoglobin (HbA1c%) in whole blood (capillary or venous). The reaction solution contains components that lyse (dissolve) erythrocytes (red blood cells) and boronate resin, which binds cis-diols of glycated hemoglobin. Blood sample (4 μl) is applied to the collection area of ​​the reagent pack. The reagent pack is then inserted into the cassette in which red blood cells immediately dissolve (lyse) and release hemoglobin, with the boronate resin binding the glycated hemoglobin. The folded cassette is inserted into CLOVER A1c Self analyser and rotated so that the blood sample mixture enters the cassette measuring zone, where the amount of total hemoglobin in the blood sample is photometrically measured by a reflectance photosensor consisting of a light emitting diode (LED) and a photodiode (PD-Photo Diode). The combined cassette is then rotated so that the wash solution washes the nonglycated hemoglobin from the blood sample so that the amount of glycated hemoglobin can be measured photometrically.

CLOVER A1c Self analyser had been programmed to produce standardised results according to the DCCT (Diabetes Control and Complications Trial).

"A" and "B" are value correction factors for DCCT calibration.