BioSensory SD A1cCare, User Instruction Manual

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CHAPTER 1. Understanding Your New Analyzer
1. Indication for Use; Purpose of the analyzer
SD A1cCare™ analyzer work to measure the quantitative measurement of the
glycohemoglobin(HbA1c) in the blood. The analyzer is indicated for monitoring the blood
parameter in fresh capillary or venous whole blood. SD A1cCare™ analyzer should be used
with SD A1cCare™ test kit. Testing is done outside the body (in vitro diagnostic use). This
analyzer is indicated in clinical settings by healthcare professionals.
2. Test principle
SD A1cCare™ System is based on a reflectometry and immunoassay technology. SD
A1cCare™ Test kit uses an anti-HbA1c(%) antibody which is specific for the first few amino
acid residues of the glycated N-terminus of the β-chain of hemoglobin A0. SD A1cCare™
Test Kit contains the test panel, latex-tablet and buffer solution. The buffer solution is
instantly lysed to release the glycated hemoglobin(HbA1c) and the latex-tablet included
the blue dyed latexmicroparticles conjugated to specific antibodies. When whole blood
is added to the buffer solution and is mixed with the latex-tablet, the erythrocytes are
instantly lysed to release the glycated hemoglobin (HbA1c).
When sample mixture is loaded onto the sample port of the Test panel, the mixture fluid
migrates along the membrane of Test panel by capillary action and then HbA1c has been
immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates
on the anti-HbA1c line reflects the amount of HbA1c in the sample. For measuring of
total hemoglobin in the sample, the intensity of the hemoglobin color measured from the
desired area on the membrane of test panel is measured. Chemical and immuno reaction
that occurs on the test panel are measured by optical system in SD A1cCare™ Analyzer.
SD A1cCare™ analyzer measures both fractions and an algorithm converts the result into
the percentage HbA1c in the sample.