Quality Control - Orion Diagnostica QuikRead 101 Manual De Instrucciones

Shake the cuvette
..........
The display shows you how long you should shake the cuvette (approx. 6 seconds). The
moving dots indicate the speed of shaking. Shaking the cuvette too slowly may result in the
error message "Faulty reagent addition. Please run again". In that case, a new test needs
to be performed.
Insert the cuvette
for measurement
Place the cuvette back into 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.
QuikRead 101 sw 9.0 or newer:
Measuring 60 s
QuikRead 101 sw 8.03 or older:
Measuring 120 s
The instrument measures the haemoglobin concentration for up to 60 seconds (QuikRead
101 sw 9.0 or newer) or up to 120 seconds (QuikRead 101 sw 8.03 or older)
The display counts down from 60/120 seconds.
Do not remove the cuvette from the measurement well before the result is displayed and
recorded. Removing the cuvette too early will terminate the measurement immediately and
erase any result displayed.
The result displayed depends on the instrument and software version used.
Concentration of
haemoglobin in the
sampling tube buffer
< 100 ng Hb/ml buffer
(< 20 µg Hb/g faeces*)
100–1000 ng Hb/ml buffer
(20–200 µg Hb/g faeces*)
> 1000 ng Hb/ml buffer
(> 200 µg Hb/g faeces*)
* Providing the sample is diluted according to the instructions (10 mg faeces in 2 ml
buffer)
** a hypothetical example of buffer Hb concentration
The result appears on the display when the measurement is completed.
Performing self test
Wait....
When the cuvette is removed, the QuikRead 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
FOB
To begin a new test, place a new cuvette in the measurement well.
Brief instructions for use
1 Remove the foil cover from the cuvette. Beware of splashing the liquid.
Shake the sampling tube, break the tip of it and discard the first three drops,
2
then dispense three (3) drops into the cuvette.
3 Blank measurement max. 20 seconds.
4 Add reagent by pressing down the inner part of the cap.
Take out the cuvette and mix the contents thoroughly.
5
Put the cuvette back in the measurement well.
The instrument measures the haemoglobin concentration in the sample for
6
up to 60/120 seconds (time instrument and software version dependent).
7 Read the FOB result.
8

Quality control

Regular use of QuikRead FOB Positive Control (Cat. No. 06027) and/or QuikRead FOB
Control Quantitative (Cat. No. 144675) is recommended.
QuikRead FOB Positive Control (Cat. No. 06027):
When QuikRead 101 with software version 9.0 or newer is used, "POSITIVE FOB
•
> 1000 ng/ml" should be displayed.
In QuikRead 101 with software version 8.03 or older, "POSITIVE FOB" should be
•
displayed.
QuikRead FOB Control Quantitative (Cat. No. 144675):
When QuikRead 101 with software version 9.0 or newer is used, a result within the
•
range indicated on the control vial label should be displayed.
In QuikRead 101 with software version 8.03 or older, "POSITIVE FOB" should be
•
displayed.
9 Results' interpretation
If the instrument displays the concentration as ng/ml or text "POSITIVE FOB", the sampling
tube contains haemoglobin in a concentration higher than 100 ng/ml. Haemoglobin in
faeces is especially indicative of bleeding in the lower part of the intestine.
If the instrument displays the text "NEGATIVE FOB", the sample tube does not contain
haemoglobin or the haemoglobin concentration is < 100 ng/ml.
QuikRead 101 with sw 8.03
or older
NEGATIVE FOB
POSITIVE FOB
POSITIVE FOB
QuikRead 101 with sw 9.0
or newer
NEGATIVE FOB
FOB 391 ng/ml**
POSITIVE FOB
> 1000 ng/ml