Product Description - Abbott Afinion HbA1c Mode D'emploi

AFINION
EN
For use with the Alere Afinion
For professional near-patient testing and laboratory use.

PRODUCT DESCRIPTION

Intended use
Afinion HbA1c is an in vitro diagnostic test for quantitative determination
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of glycated hemoglobin (hemoglobin A1c, HbA1c) in human whole
blood. The measure of HbA1c is recommended as a marker of long-term
metabolic control in persons with diabetes mellitus. This test can be used
as an aid in the diagnosis of diabetes and as an aid in identifying patients
who may be at risk for developing diabetes.
Summary and explanation of the test
The human erythrocyte is freely permeable to glucose. Within each
erythrocyte a slow, continuous, non-enzymatic process between
hemoglobin A and various sugars takes place. The product formed is known
as glycated hemoglobin, or glycohemoglobin
sugar level of persons with diabetes mellitus will over time cause damage to
the small vessels of the body. This damage develops slowly over years and
is known to cause late complications. Good metabolic control, i.e. lowering
the HbA1c concentration, has proven to delay the onset and slow the
progression of diabetes late complications
An International Expert Committee has concluded that measurements of
HbA1c can be used to diagnose diabetes mellitus. When in agreement with
national regulations, Afinion HbA1c can be used as an aid in the diagnosis
of diabetes and as an aid in identifying patients who may be at risk for
developing diabetes
Principle of the assay
Afinion HbA1c is a fully automated boronate affinity assay for the
determination of hemoglobin A1c in human whole blood.
The Afinion HbA1c Test Cartridge contains all the reagents necessary
for the determination of the HbA1c concentration. The sample material
is collected using the integrated sampling device and the test cartridge
is placed in the Afinion Analyzer. The blood sample is then automatically
diluted and mixed with a liquid that releases hemoglobin from the
erythrocytes. The hemoglobin precipitates. This sample mixture is
transferred to a blue boronic acid conjugate, which binds to the cis-diols
of glycated hemoglobin. This reaction mixture is soaked through a filter
membrane and all precipitated hemoglobin, conjugate-bound and unbound
(i.e. glycated and non-glycated hemoglobin) remains on the membrane.
Any excess of conjugate is removed with a washing reagent.
The Afinion Analyzer evaluates the precipitate on the membrane. By
measuring the reflectance, the blue (glycated hemoglobin) and the red
(total hemoglobin) colour intensities are evaluated, the ratio between them
being proportional to the percentage of HbA1c in the sample. The HbA1c
concentration is displayed on the Afinion Analyzer in the units
mmol/mol, percentage (%), as the calculated estimated average glucose
(eAG) or in combinations of these.
Kit contents (per 15 tests unit)
• 15 Test cartridges packaged separately in foil pouches with
a desiccant bag
• 1 Package insert
HbA1c
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AS100 Analyzer/Afinion
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2
. The chronic elevated blood
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3,4,5
2 Analyzer.
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