Warnings And Precautions - AIDIAN QuikRead go HbA1c Kurzanleitung

5

Warnings and precautions

Health and safety information
● For in vitro diagnostic use only.
● Do not smoke, eat or drink in premises where samples or kit reagents are handled.
● Wear suitable personal protective clothing and disposable gloves when handling patient
samples and kit reagents. Wash hands thoroughly when finished performing the test.
● Avoid contact with skin and eyes. After contact with skin, wash immediately with plenty
of water.
● Lyophilised reagent inside the caps contains a mixture of methyl-
chloroisothiazolinone
to aquatic life with long lasting effects (H412). Avoid release to the
environment (P273). The concentration of methylchloroisothiazolinone and
methylisothiazolinone in a reagent cap is 0.0064%, which is considered to
cause skin sensitivity (Skin Sens 1). May cause an allergic skin reaction
(H317). Do not get in eyes, on skin, or on clothing (P262). Wear protective gloves/
protective clothing/eye protection/face protection (P280). IF ON SKIN: Wash with plenty
of soap and water (P302+P352). Dispose of contents according to national and local
law (P501).
● Reconstituted and liquid reagents contain <0.0015% methylchloroisothiazolinone and
methylisothiazolinone, which is not considered as a harmful concentration.
● Disposal: see Section 15.
Analytical precautions
● Do not use the product after the expiry date marked on the outer package.
● Do not exceed the stability periods for opened reagents.
● Do not freeze the QuikRead go HbA1c kit.
● The QuikRead go HbA1c kit is intended solely for use with the QuikRead go instrument.
● Do not mix components from different lot numbers or different tests. The components are
disposable; never reuse components for performing a test.
● When opening a kit for the first time, ensure that the foil pouches protecting the cuvettes
are intact. If a foil pouch is damaged, do not use the cuvettes inside it. Always ensure
before using an individual cuvette that its foil covering is intact.
● Do not touch the clear flat surfaces on the lower part of the cuvette (optical part). Discard
any cuvettes with fingerprints.
● QuikRead go HbA1c Reagent Caps are colour-coded light violet to distinguish them from
other QuikRead analytes. QuikRead go Sample Collector 1µl has a colorless plastic
frame. Do not use broken sample collectors.
● Keep the QuikRead go HbA1c Reagent Caps away from moisture. Close the aluminium
tube immediately after taking out the required number of reagent caps. Do not use the
reagent caps if they have not been stored according to the instructions.
● Do not splash liquid into the measuring well of the instrument.
● Do not perform the HbA1c test on an inclined surface.
6 Sample collection and preparation
Sample material, collection and volume
QuikRead go Sample Collector 1µl (Cat. no. 154457) included in the kit (Cat. no. 151058) is
required for transferring the sample into a cuvette. The capillary part of the sample collector
is covered with EDTA and the appearance might vary depending on the crystallization of
the EDTA.
Sample Sample
material volume
Finger prick
capillary 1 μl
blood
Anticoagu-
lated whole 1 μl
blood
Sample dilution
Do not dilute samples.
Sample storage
Sample material
Finger prick capillary blood
Anticoagulated whole blood
Sample in the cuvette
Allow the samples to reach room temperature (18...25ºC) before testing.
and methylisothiazolinone,
Sample collection
Prick the clean and dry finger with a lancet. Wipe off the first
drop and collect 1 μl of blood from the second drop into EDTA
covered capillary part of the sample collector.
Use a venous blood sample collected in a tube containing
Li-heparin, K2-EDTA or K3-EDTA. Mix the whole blood by
inverting the tube several times and collect 1 μl using the
sample collector.
Short-term storage
Max. 1 minute in the sample
collector.
2...8°C for 3 days. Do not use
hemolyzed samples.
18...25°C for max. 5 minutes in
the sample collector inside the
cuvette with a closed cap.
which is harmful
Long-term storage
Do not store
Do not store
Do not store
Warning