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1. INTENDED USE
2. General Information
The
CLOVER A1c
®
analyzer is an IVD(In Vitro Diagnostic Device) device for measuring
Hemoglobin A1c by the well established method of boronate affinity. It is able to analyze
both capillary whole blood and venous blood. Anticoagulants may be used, such as
EDTA(ethylenediaminetetraacetic acid) and heparin etc. This
CLOVER A1c
®
system is
designed to help controlling diabetes and it is intended to be used by professionals in
laboratories, clinics and hospitals. Same as all diagnostic tests, do not make a definitive
diagnosis of diabetes based on the result of
a single test. A physician should make a diagnosis after all clinical and laboratory
findings are evaluated.
The
CLOVER A1c
®
Analyzer uses the reflectance spectrophotometer for measuring the
Hemoglobin A1c. It is easily validated with the Check Cartridge provided with the Analyzer
kit for quality assurance.
The Analyzer also includes a DC 9 V, 2A adapter. Using other adapters may affect the
analyzer and give inaccurate test results.
Calibration
The
CLOVER A1c
®
Analyzer has been programmed to produce results that are
standardized to DCCT (Diabetes Control and Complications Trial).
The DCCT is a landmark multi-center trial which conclusively linked elevated HbA1c
level to the complications associated with Diabetes.
The DCCT showed the importance of improved glycemic control in reducing the risk and
progression of the complications of diabetes. Glycemic control was determined by the
measurement of Hemoglobin A1c. The ADA (American Diabetes Association) recom-
mends measurement of the Hemoglobin A1c levels of two to four times per user, with
less frequency in patients with stable control, and more frequency in patients with
unstable control.
3. Principles of Operation
3.1 Reflectance Spectrophotometry
The
CLOVER A1c
®
system is a fully automated boronate affinity assay for the
determination of the percentage of Hemoglobin A1c(HbA1c%) in whole blood.
The
CLOVER A1c
®
system Test Cartrideg includes a cartridge and reagent pack.
The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent
solution contains agents that lyse erthrocytes and boronate bead that binds cis-diols of
glycated hemoglobin.
The blood sample (4µL) is collected at the sampling area of the reagent pack.
The reagent pack is then inserted into the cartridge, where the blood is instantly lysed
releasing the hemoglobin and the boronate resin binding the glycated hemoglobin.
The blood sample mixture is rotated to 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, which consists of LED (Light Emitting Diode) and PD (Photo Diode).
The cartridge is then rotated so that the rinsing 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.
3.2 calculation of Results
'A' and 'B' are the slope and intercept factor to correct the value for DCCT calibration.
Total Hemoglobin
A
B
