CLOVER A1c Self
• 4 •
1. INTENDED USE
2. INTRODUCTION
The
CLOVER A1c Self
analyzer is an IVD(In Vitro Diagnostic Device) device for
measuringHemoglobin A1c by the well established method of boronate affinity. It is able
to analyze bothcapillary whole blood and venous blood. Anticoagulants may be used,
such asEDTA(ethylenediaminetetraacetic acid) and heparin etc. This
CLOVER A1c Self
system is designedto help controlling diabetes and it is intended to be used by patients
and professionals at home,laboratories, clinics and hospitals. Same as all diagnositc
tests, do not make a definitivediagnosis of diabetes based on the result of a single test.
A physician should make a diagnosisafter all clinical and laboratory findings are
evaluated.
IMPORTANT :
Please read through and familiarize yourself with the contents of this
operation manual before using the system for the first time.
The
CLOVER A1c Self
system is a small, portable and fully automated point-of-care
system forHbA1c test. The system delivers rapid tests of HbA1c.
The
CLOVER A1c™ Self
System may be used as a basic test system where the user
purchases the Analyzer and manually records the results, or as an advanced system
where a suite of accessories enable automatic printing of results, input of patient and
operator identification numbers, and full connectivity to a PC. In this manner, the system
is highly versatile and can be tailored to specific user needs.
This manual contains all the information needed to operate and maintain the
CLOVER
A1c™ Self
Analyzer.
CLOVER A1c Self
• 5 •
3. PRINCIPLES OF OPERATION
The
CLOVER A1c™ Self
system is a fully automated boronate affinity assay for the
determination of the percentage of Hemoglobin A1c (HbA1c %) in whole blood(capillary
and venous).
The Test Cartridge is composed of a cartirdge and a reagent pack containing the
reagents necessary for the determination of hemoglobin A1c.
A cartridge should be inserted into the analyzer cartridge holder first and later assembled
with areagent pack which was applied with 4ul blood sample at the sample collecting
area. A reagentpack is composed of reaction solution and washing solution. The reaction
solution containshemolyzing agent which lyses the red blood cells, and boronate resin
which binds to the cis-diolsof glycated hemoglobin. The washing solution cleans the non-
specific glycated hemoglobin(except HbA1c)
The blood sample(4uL) is collected at the collection area 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™ Self
Analyzer and rotated
so that the sample mixture is placed at the measurement zone of the cartridge, where the
amount of total hemoglobin in the blood sample is photometrically the diffused
reflectance of the optical sensor composed with LED(Lgiht Emitting Diode) andPD(Photo
Diode)
Then, the assembled cartirdge 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.
Where ‘HbA1c’ and ‘Total Hemoglobin’ are the signal obtained from the
CLOVER A1c™
Self
system, ‘A’ and ‘B’ are the slope and intercept factor to correct the value for
DCCT(Diabetes Control and Complication Trial) calibration.
Total Hemoglobin
A
B
Summary of Contents for CLOVER A1c Self
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