Quality Control - Orion Diagnostica QuikRead 101 Manual De Instrucciones

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 shake 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.
Insert the cuvette
for measurement
Place the cuvette in the measurement well of the instrument. If the cuvette is inserted
back too early, the error message "Test cancelled" or "Cuvette inserted too early" will be
displayed. If the cuvette is reinserted too late, the error message "Cuvette inserted too late"
will be displayed. In both cases, a new test needs to be performed.
Measuring 55 s
The instrument measures the CRP concentration within the time shown on the display.
The display shows the time left before completion. Do not remove the cuvette from the
measurement well before the result is displayed and recorded. Cuvette removal will
terminate the measurement immediately.
Sample: <XXX> / date
Result: <XXX> CRP
The result is shown in the display as mg/l.
Performing self test
Wait....
When the cuvette is removed, the QuikRead 101 instrument automatically performs a self-
check. If the self-check is not successful, discard the previous test result. After a successful
self-check the LCD will display:
Ready for use CRP
To begin a new test, place a cuvette in the measurement well.
Brief instructions for use
1 Remove the foil cover from the cuvette. Beware of splashing the liquid.
2 Add 20 µl of whole blood. Put the cap on and mix gently (not upside down).
3 Blank measurement.
4 Add reagent by pressing down the inner part of the cap.
Take out the cuvette and mix thoroughly.
5
Put the cuvette back in the measurement well.
6 The instrument measures CRP concentration.
7 Read the CRP result.
Sample dilution
QuikRead CRP test gives numerical value up to 160 mg/l. To obtain numerical value for
higher concentrations, dilute the sample with 0.9 % NaCl. Dilution ratio is 1+1 (1 part of
volume sample and 1 part of volume 0.9 % NaCl). Take 20 µl of the diluted sample into a
new cuvette, repeat the assay and multiply the result by 2.
8

Quality control

Regular use of QuikRead CRP Control (Cat. No. 68296) is recommended. The control value
is specified for a volume of 20 µl with the same instructions for use as for whole blood
samples.
9 Results' interpretation
Increases in CRP are nonspecific and should not be interpreted without a complete clinical
history.
Elevated CRP range
Concentrations of < 10 mg/l exclude many acute inflammatory diseases but do not
specifically exclude inflammatory processes. Elevated concentrations of < 50 mg/l in
acute disease occur in the presence of slight to moderate inflammatory processes. Values
> 50 mg/l indicate high and extensive inflammatory activity
Effect of haematocrit for whole blood samples
The calibration of the reagents for whole blood has been made assuming that the value
for haematocrit is approximately 40 % and a plasma proportion is 60 %. If the actual
haematocrit value deviates from 40 %, the corrected CRP value can be calculated by
multiplying the whole blood result by the factor given below:
Haematocrit
(%)
20–29
30–36
37–42
43–47
48–51
52–55
56–58
OR
Factor Haematocrit
(%)
0.8 59–61
0.9 62–63
1.0 64–65
1.1 66–67
1.2 68–69
1.3 70
1.4 71–72
Add reagent
Lift the cuvette
Factor
1.5
1.6
1.7
1.8
1.9
2.0
2.1
.
8
Haematocrit
(%)
73
74
75
76–77
78
79
80
Factor
2.2
2.3
2.4
2.6
2.7
2.9
3.0