Orion Diagnostica QuikRead CRP Manual De Instrucciones página 3

of the capillary. Make sure the soft tissue does not draw any sample from inside the capillary.
Put the end of the capillary in the buffer and empty the capillary into the buffer by pressing
down the plunger. Make sure the capillary is emptied completely.
6.2 Alternative sample materials
Anticoagulated whole blood: Whole blood collected in a tube containing heparin or EDTA
can be used. Mix the whole blood by inverting the tube. Perform the test as outlined in
Section 7 "Procedure". The sample volume is 20 μl. The 20 μl capillaries are recommended
for adding the sample.
Serum: Take a normal venous blood sample and separate the serum. Perform the test as
outlined in Section 7 "Procedure". Sample volumes of 12 or 20 μl can be used, noting the
effect of sample volume as stated below.
Plasma: Collect whole blood in a tube containing an anticoagulant such as heparin or
EDTA. Separate the plasma from the blood cells as soon as possible to avoid haemolysis.
Mild haemolysis in samples will not affect the test results. Perform the test as outlined in
Section 7 "Procedure". Sample volumes of 12 or 20 μl can be used, noting the effect of
sample volume as stated below.
Sample volume for serum or plasma samples
1) Pipette 12 µl of the plasma or serum sample. The final result appears in the display.
OR
2) Pipette 20 µl of the plasma or serum sample and multiply the result shown in the display
by 0.6.
Sample storage
Sample material
Anticoagulated
whole blood
Serum
Plasma
Samples should not be repeatedly frozen and thawed.
Allow the samples to reach room temperature (18...25°C) before testing.
Frozen samples must be thawed completely, mixed thoroughly, brought to room temperature
and centrifuged prior to testing.
6.3 Control materials
QuikRead CRP Control: QuikRead CRP Control is ready-to-use. Perform the test as
outlined in Section 7 "Procedure". The sample volume is 20 μl. The 20 μl capillaries are
recommended for adding the sample.
Other commercially available controls: Handle and use according to the instructions for
each control substance. Serum- and plasma-based controls should be used in the same
way as plasma and serum samples, see Section 6.2.
6.4 Use of QuikRead 1 ml Dispenser
The dispenser is a 1 ml accuracy dispenser. Screw the dispenser tightly onto the buffer bottle.
Ensure that the dispenser is functioning properly by dispensing a few times and discarding the
dispensed buffer. The buffer bottle contains excess buffer for this purpose. Press the plunger
down in one smooth stroke. Avoid letting the button "snap" back. One stroke corresponds to
1 ml of buffer.
To avoid contamination, use the dispenser only with QuikRead CRP. The dispenser is
delivered with labels indicating the tests for which the dispenser can be used. After unpacking
the dispenser, stick the label indicating the test you are going to use the dispenser for, onto
the dispenser.
See the instructions manual of the dispenser for more detailed information.
7 Procedure
Materials required but not supplied
QuikRead 101 Instrument
QuikRead 1 ml Dispenser
QuikRead CRP Control
Fingertip lancets for the whole blood
procedure
A pipette for dispensing 12 μl volumes
Assay procedure
All reagents should be allowed to reach room temperature (18...25°C) before use. Use the
samples undiluted.
The subheadings correspond to messages displayed by the instrument.
Read the card
Read the magnetic card by pulling it through the reader slot with the magnetic band facing you.
Ready for use
CRP
1) Dispense 1 ml of buffer into the cuvette, using QuikRead
1 ml Dispenser. Make sure that the volume is correct by
checking that the liquid surface is between the two lines
marked on the cuvette.
2) Add 20 µl of undiluted whole blood sample to the cuvette,
using a capillary. For plasma and serum sample volumes
and the use of capillaries, see Section 6 "Sample collection
and preparation".
3) Close the cuvette tightly with a CRP Reagent Cap. Put the cap properly on the cuvette
to prevent leakage from the cuvette. Do not press down the blue inner part of the cap.
Do not touch the clear flat surfaces in the lower part of the cuvette (the optical part).
Mix by shaking gently (do not turn the cuvette upside down). Wait until the whole blood
sample solution becomes bright red upon haemolysis. Insufficient haemolysis may
cause the error message "Unstable sample. Please run again" to be displayed. If not
measured immediately, the sample may be stored in the buffer for one hour. Before
measuring the blank, mix again.
4) Put the cuvette in the measurement well of the instrument.
Measuring blank
The instrument measures the sample blank. This will take a maximum of 40 seconds. Do
not touch the cuvette in the measurement well during the measurement. In case the error
message "Unstable sample. Please run again" is displayed, repeat the blank measurement
with the same cuvette.
Blank measured
Add reagent
1) Press down the blue inner part of the cap (using, for
example, your finger or a pen). This will release the dried
CRP reagent into the cuvette.
2) Take the cuvette from the measurement well and mix the
contents very rapidly by shaking the cuvette vigorously.
The whole blood sample solution in the cuvette becomes
opaque red. Foaming of the mixture does not disturb the
measurement.
Shake the cuvette
...........
The display shows you how long you should mix the cuvette (approx. 6 seconds). The
moving dots indicate the pace of vigorous shaking. Too slow shaking may cause the error
message "Faulty reagent addition. Please run again" to be displayed. In that case a new
test needs to be performed.
Short-term storage
2...8°C for 3 days
2...8°C for 7 days
2...8°C for 7 days
Cat. No.
06040
05560
68296
OR
Long-term storage
Separate plasma
and store below –20°C
Below –20°C
Below –20°C
Supplied with the instrument
Recommended for quality control
For plasma and serum samples
(see Section 6.2)
Add reagent
Lift the cuvette