Product Description - Abbott NycoCard HbA1c Manual Del Usuario

NycoCard
For professional near-patient testing and laboratory use. For use with the NycoCard
The NycoCard Reader II is calibrated for use with the NycoCard Tests only.

PRODUCT DESCRIPTION

Intended use
NycoCard HbA1c is an in vitro diagnostic
™
medical device for quantitative determination of
glycated hemoglobin (HbA1c) in human whole
blood. For monitoring of long-term metabolic
control in persons with diabetes mellitus
Principle of the assay
NycoCard HbA1c is a boronate affinity assay.
The kit contains test devices with a porous
membrane filter, test tubes prefilled with
reagent and a washing solution. The reagent
contains agents that lyse erythrocytes and
precipitate hemoglobin specifically, as well as a
blue boronic acid conjugate that binds cis-diols
of glycated hemoglobin. When blood is added to
the reagent, the erythrocytes immediately lyse.
All hemoglobin precipitates. The boronic acid
conjugate binds to the cis-diol configuration of
glycated hemoglobin. An aliquot of the reaction
mixture is added to the test device, and all the
precipitated hemoglobin, conjugate-bound and
unbound, remains on top of the filter. Any
excess of coloured conjugate is removed with the
washing solution. The precipitate is evaluated by
measuring the blue (glycated hemoglobin) and
the red (total hemoglobin) colour intensity with
the NycoCard Reader II, the ratio between them
being proportional to the percentage of HbA1c
in the sample.
TEST CHARACTERISTICS
Analytical specificity
NycoCard HbA1c measures the total glycated
hemoglobin and reports the HbA1c value.
The following hemoglobin (Hb) variants have
been analysed and found not to affect the
NycoCard HbA1c Test result: HbAC, HbAE,
HbAF, HbAJ, HbAS and Hb Yamagata
Carbamylated and pre-glycated hemoglobin
does not affect the test.
HbA1c
™
.
1,2,3
4,5
NycoCard HbA1c
Kit contents, 24 Tests
TD/Test Device
Plastic device containing a membrane filter.
R1/Reagent
Glycinamide buffer containing dye-bound
boronic acid and detergents.
R2/Washing Solution
Morpholine buffered NaCl solution and
detergents.
Material required but not provided
with the kit
• Capillary tube or pipette (5 μL) for sample
collection
• Capillary tube holder
• Pipette (25 μL) and pipette tips
• NycoCard Reader II
Warnings and precautions
• For in vitro diagnostic use.
• Do not interchange components from different
test kit lots.
• Do not use test kits after the expiry date.
• R1/reagent and R2/washing solution contain
sodium azide, which is a toxic agent.
• R2/washing solution contains morpholine,
which is a toxic agent.
• Use gloves.
Standardization
NycoCard HbA1c is traceable to the IFCC
Reference Method for Measurement of HbA1c
.
EN
Reader II.
™
1 x 24 units
1 x 24 x 0.2 mL
1 x 2.0 mL
.
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