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The HbA1c Testing is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c (HbA1c %) in human whole blood.
The CLOVER A1c Test Cartridge is composed of a Cartridge and a Reagent Pack containing the reagents necessary for the determination of hemoglobin A1c, with a collection leg for blood sample collection.
The Reagent Pack is pre-filled with reaction solution and washing solution. The reaction solution contains agents that lyse erythrocytes and bind hemoglobin specifically, as well as a boronate resin that binds cis-diols of glycated hemoglobin. Blood sample (4µL) is collected at the collection leg of the Reagent Pack, then the Reagent Pack is inserted into the Cartridge, where the blood is instantly lysed releasing the hemoglobin and the boronate resin binding the glycated hemoglobin. The assembled Cartridge is inserted into the CLOVER A1c Analyzer and rotated so that the blood sample mixture is placed at the measurement zone of the Cartridge, where the amount of total hemoglobin in the blood sample is measured by the reflectance of the photo sensor LED (Light Emitting Diode) and PD (Photo Diode).
Then, the assembled Cartridge is rotated so that the washing solution washes out non-glycated hemoglobin from the blood sample, thus the amount of glycated hemoglobin can be photometrically measured.
The ratio of glycated hemoglobin with respect to total hemoglobin in the blood sample is calculated.
4µL Blood Sample
Test Result in 5 Minutes
Calculation of Results
Where 'D' is the signal obtained from the HbA1c Testing, and 'C' and 'F' are the slope and intercept factor to correct the value for DCCT calibration.
|Sample Type:||Capillary wole blood/Venus blood with anticoagulant|
|Reading Time:||5 minutes|
|Memory Capacity:||200 test results|
|Precision Reflectance Readings:||< 1% CV|
|Wavelength:||440 nm (normal)|
|Signal to noise :||> 1000 : 1|
|Power Required:||DC 9 V-1.5 A|
|Relative Humidity Range:||10% ~ 90%|
|Data download:||USB port|
|Option:||Blood Glucose Module, PC Connection Cable, Thermal Printer, Bar-code Scanner||
Testing with the CLOVER A1c