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 mix components from different lot numbers or different tests. The components
are disposable; never reuse components already used for performing a test.
●
When opening a kit for the first time, ensure that the foil pouches (2 pcs) protecting
the cuvettes are intact. If a foil pouch is damaged, do not use the cuvettes inside it. In
addition, 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.
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QuikRead FOB reagent caps are colour-coded brown to distinguish them from other
QuikRead analytes.
●
Keep the QuikRead FOB Reagent Caps away from moisture. Close the aluminium tube
immediately after taking out the required number of reagent caps.
●
Make sure that the correct magnetic card for the QuikRead FOB quantitative test is
used. The magnetic card must not be bent or exposed to liquids or strong magnetic
fields.
●
Do not splash liquid into the measuring well of the instrument.
6
Sample collection and preparation
The patient does not have to undertake any special diet prior to faeces sampling. Provide
the patient with the FOB sampling tube, a patient label and a copy of the following sampling
instructions. Explain the instructions to the patient.
Do not drink the liquid in the sampling tube. Take care not to bend or break the tip
of the tube.
●
Obtain a sample of faeces in a clean container or on clean collecting paper. Avoid
contact with the toilet water when you are collecting the sample. If there is visible blood
in the faeces sample or in case of diarrhea, do not collect a sample but wait for the next
bowel movement and collect a sample from that.
●
Unscrew the top of the sampling tube containing the sample collecting stick. Collect
the sample by poking the sample collecting stick (attached to the tube cap) in three (3)
different places on the faeces sample.
●
Insert the sample collecting stick back into the sampling tube and screw the cap on
firmly.
●
Write your name and the date on a separate label and attach the label to the sampling
tube.
●
Return the FOB sampling tube to the laboratory or doctor as soon as possible after
sampling. Protect the sampling tube from breakage or leakage during transportation.
●
The sample in the sampling tube can be stored in a refrigerator (2...8°C) for up to 5
days or at room temperature (max. 25°C) for up to 24 hours. Storage in refrigerator is
however preferred.
Allow the sample to reach room temperature (18...25°C) before testing.
7
Procedure
Materials required but not supplied
QuikRead
101 Instrument
®
QuikRead
FOB Sampling Set (50 sampling tubes)
®
QuikRead
FOB Positive Control
®
QuikRead
FOB Control Quantitative
®
Assay Procedure
Before starting the assay, please read chapter 5 "Warnings and precautions".
All reagents should reach room temperature (18...25 °C) before use. Upon removal
from refrigerated storage, discard the foil pouch of cuvettes and let them stay at room
temperature before use. It will take 15 minutes for an individual refrigerated prefilled cuvette
to reach room temperature.
The measurement time of the assay depends on the instrument software version. With the
QuikRead 101 software version 9.0 or later, the assay reaction time is max. 1 minute. With
older software versions (8.03 or lower) the assay reaction time is max. 2 minutes.
Process the sample immediately after receiving it – preferably within three days of sampling.
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
FOB
1) Check that each sampling tube is marked with the patient's ID and
sampling date. If the label is missing, mark the vial with the patient's
ID and sampling date.
2) Remove the foil cover from the cuvette. Beware of splashing the
liquid. Condensed buffer on the foil cover has no effect on results.
The test must be performed within two hours from opening the cuvette.
3) Make sure that the volume is correct by checking that the liquid surface is between the
two lines marked on the cuvette.
4) Shake the sampling tube, break the tip of it and discard the first three drops. Then
dispense 3 drops into the cuvette.
5) Close the cuvette tightly with the FOB Reagent Cap and mix by shaking gently (do not
turn the cuvette upside down).
Do not press down the brown inner part of the reagent cap.
6) Put the cuvette into the measurement well of the instrument.
Measuring blank
The instrument measures the sample blank. This will take a maximum of 20 seconds. Do
not touch the cuvette in the measurement well during the measurement.
Add reagent
Lift the cuvette
7) Press down the brown inner part of the reagent cap to add reagent
(using, for example, your finger or a pen). This will release the FOB
Reagent into the cuvette.
8) Take the cuvette from the measurement well and mix very rapidly by
shaking the cuvette vigorously.
9) The solution becomes milky white. Be careful not to touch the clear
flat surfaces on the lower part of the cuvette (optical part).
Cat. No.
06078
138822
06027
144675