Troubleshooting - Orion Diagnostica QuikRead CRP Manual De Instrucciones

Interference
Interfering substance
Rheumatoid factors (RF)
Bilirubin
Triglycerides**
**The instrument displays the error message "Sample blank too high. Please run again" if
the sample is too lipaemic. It is recommended that highly lipaemic or precipitated samples
be clarified by centrifuging (e.g. 10 min at 15000 x g) before assaying.
EDTA and heparin as anticoagulants in the samples do not interfere with the test.
Most heterophilic or anti-sheep antibodies in the samples do not interfere with the test, as
the assay antibodies lack the Fc-part. In rare cases, interference by IgM myeloma protein
has been observed.
Antigen excess
CRP concentrations less than 600 mg/l do not give falsely low results.
Whole blood versus plasma comparability
In a comparison involving 180 patient samples, the results for whole blood and plasma were
found comparable.
13 Traceability
The calibrators used to calibrate the CRP assay of the QuikRead CRP test are traceable to
the ERM -DA474 reference material.
®
14 Disposal
● Dispose of contents according to national and local law.
● All patient samples, used caps, cuvettes, capillaries and plungers should be handled
and disposed of as potentially infectious material.
● Materials of the components:
Paper: Instructions for use
Cardboard: Kit box
Plastic: Cuvettes, reagent caps, foil covering cuvette rack, cuvette rack, plungers,
plunger and capillary tubes
Glass: Capillaries
Metal: Reagent cap tubes, cuvette lids, plunger and capillary tube caps
Several (not to be recycled): Lids of reagent cap tubes
● When used in accordance with Good Laboratory Practice, good occupational hygiene
and the instructions for use, the reagents supplied should not present a hazard to health.
15

Troubleshooting

Problem
Unstable sample
Please run again
Faulty reagent addition
Please run again
Unexpected low results
Unexpected high results
For troubleshooting, see also the QuikRead 101 Instrument instructions for use.
Concentration
≤ 525 IU/ml
≤ 400 µmol/l
≤ 10 mmol/l (Intralipid)
y (whole blood) =
r =
Possible cause
The sample has not
stabilised within the time
allowed.
Inadequate absorbance
after adding the reagent.
It may be that shaking
has been too slow, no
reagent has been added
or the dispenser is
malfunctioning.
Too small sample volume
Incorrect buffer volume
Insufficient mixing
after adding the reagent
Incorrect reagent storage
Components from different
kit lots or tests are used.
Too large sample volume
Incorrect buffer volume
The cuvette is dirty.
Incorrect reagent storage
Components from different
kit lots or tests are used.
1.04 x (plasma) – 0.32
0.99
Interference
none
none
none
Corrective action
Shake the cuvette
gently and replace it in
the measurement well;
the assay should now
continue.
Retest the sample.
Make sure that the
reagent is added
and shaking is done
vigorously enough as
outlined in section 10.
Make sure that the
buffer volume is correct.
Retest the sample.
Make sure that the
capillary is completely
filled. Avoid air bubbles.
Retest the sample.
Make sure that the
volume is correct by
checking that the liquid
surface is between the
two lines marked on
the cuvette.
Retest the sample.
The moving dots on
the display indicate the
pace and duration of
shaking.
Retest the sample.
Make sure that all the
reagents are stored
according to the
instructions for use.
Retest the sample.
Make sure that all the
reagents are from the
same kit lot.
Retest the samples.
Wipe excess sample
from the outer surface of
the capillary. Make sure
that the sample is taken
at the end with the white
stopper and the plunger
is inserted at the end
with the blue stripe.
Retest the sample.
Make sure that the
volume is correct by
checking that the liquid
surface is between the
two lines marked on
the cuvette.
Retest the sample. Do
not touch the clear flat
surfaces in the lower
part of the cuvette.
Retest the sample.
Make sure that the
reagents are stored
according to the
instructions for use.
Retest the sample.
Make sure that all the
reagents are from the
same kit lot.