Warnings And Precautions - Abbott Afinion HbA1c Mode D'emploi

Materials required but not provided with the kit
• Alere Afinion AS100 Analyzer/Afinion 2 Analyzer
• Afinion HbA1c Control
• Standard blood collection equipment
Description of the test cartridge
The main components of the test cartridge are the sampling device and
the reagent container. The test cartridge has a handle, a barcode label with
lot-specific information and an area for sample ID. See figure and table
below.
Left side
Component
1 Sampling device
a. Closed position
b. Lifted position
2 Capillary
3 Reaction wells
a. Conjugate
b. Membrane tube
c. Washing solution
d. Reconstitution
reagent
e. Empty
4 Handle
5 Barcode label
6 Optical reading area
7 ID area

WARNINGS AND PRECAUTIONS

• For in vitro diagnostic use.
• Do not use test cartridges after the expiry date or if the test cartridges
have not been stored in accordance with recommendations.
• Do not use the test cartridge if the foil pouch or the test cartridge has
been damaged.
• Each foil pouch contains a desiccant bag with 1 g silica gel. This material
shall not be used in the assay. Discard the desiccant bag in a suitable
container. Do not swallow.
• Do not use the test cartridge if the desiccant bag is damaged and
desiccant particles are found on the test cartridge.
EN
6 Afinion HbA1c
Function/composition
For collection of patient sample or control.
1.5 µL capillary to be filled with sample material.
Contains reagents necessary for one test:
Blue boronic acid conjugate.
Tube with a polyethersulfone membrane.
Morpholine buffered sodium chloride
with detergents and preservative.
HEPES buffered sodium chloride with
lysis and precipitation agents.
N/A
For correct finger grip.
Contains assay- and lot-specific information
for the analyzer.
Area for transmission measurement.
Space for written or labelled sample
identification.
Right side