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Analytical specificity
Precision
Monoclonal antibodies specific to human
A coefficient of variation (CV) of 15-20%
CRP are used in the test. No other
is usually obtained, depending on the
human blood components are found to
CRP level (Ref. 3-4). NycoCard
cross react with CRP in the NycoCard
®
Visual corresponds to the former
CRP Visual test system.
NycoCard
referred to in these articles.
Standardisation
Limitations of the test
NycoCard
®
CRP Visual is calibrated
against CRM 470 (IFCC/BCR/CAP refe-
Heparin, citrate or EDTA, used as anti-
rence preparation).
coagulant, do not interfere with the test.
Increased levels of bilirubin, lipids or
rheumatoid factor (RF) have none or
Measuring range
negligible effect on the test results. Very
Measuring range: 10-200 mg/L
high leukocytes levels (> 40x10
Measuring interval (Reference Colour
the sample might cause falsely elevated
Chart): 10, 25, 50, 100 and 200 mg/L.
results (see "Trouble Shooting"). Cor-
rections should be made for hematocrit
Reference range
if this is higher than normal (see "Effect
The reference range (normal range) for
of hematocrit").
CRP in serum is usually reported as less
than 6 mg/L (Ref. 1-2).
STABILITY AND STORAGE
Stability of test kit and kit components
- Avoid direct sunlight or exposure to temperatures above 25°C for all kit components.
- Test kit or kit components should not be frozen.
- The expiry date refers to the last day of the stated month.
- Most kit components can be stored at room temperature for limited periods, but
should be kept refrigerated when not in use (at the end of the working day).
Test kit/
Unopened
Kit components
2...8°C
2...8°C
Test kit
Until expiry date
See individual
components
R1/Dilution Liquid
Until expiry date
Until expiry date
R2/Conjugate
Until expiry date
Until expiry date
R3/Washing Solution
Until expiry date
Until expiry date
TC/Test Card
Until expiry date
Card in use: 4 weeks
Unused Card: 12 weeks Unused Card: 4 weeks
C+/Control Positive
Until expiry date
8 weeks
Stability of samples
Sample
2...8°C
Whole blood (with anticoagulant)
3 days
Whole blood (except for EDTA blood)
Diluted with R1/dilution Liquid
6 hours
Whole blood (with EDTA)
Storage not
diluted with R1/ Dilution Liquid
recommended*
*Diluted EDTA blood should be analyzed as soon as the blood cells are completely lysed.
TEST PROCEDURE
Important procedural notes!
®
CRP
- Bring test tube(s) with R1/Dilution
Liquid to room temperature (15-25°C)
CRP WB (Nycomed Pharma)
®
before use.
- R2/Conjugate, R3/Washing Solution
and TC/Test Cards can be used cold
or equilibrated to room temperature.
- Mark the R1 tube and the card below
the test hole with suitable patient or
control identification.
- Always use a new pipette tip.
- Do not touch the test membrane with
the pipette tip or hand.
9
/L) in
- The procedure steps should be perfor-
med successively without any inter-
ruptions.
- Caps should be screwed tightly on
after use.
Test procedure
1
Dilute sample
Fill a 25 µL capillary with patient blood or C+/Control Positive, and drop the
capillary into the tube with R1/Dilution Liquid (15-25°C). Close the tube and mix well
for 10 seconds. Leave the tube for at least 45 seconds. By visual inspection make
sure the solution is clear (complete lysis). Note! Avoid air bubbles in the capillary and
excess sample on the outside of the capillary.
2
Apply sample
Apply 25 µL diluted blood or diluted C+/Control Positive to the test hole reserved
for the sample. Allow the sample to soak into the membrane (approx. 10-20 seconds).
Opened/in use
Note! Avoid air bubbles on the membrane. Do not touch the membrane with the
15...25°C
pipette tip.
See individual
components
3
Apply R2/Conjugate
Until expiry date
Apply one drop R2/Conjugate to the test hole. Allow the reagent to soak into the
6 weeks
membrane (approx. 20-30 seconds). Note! The droplet bottle should be held vertically,
6 weeks
about 1 cm above the membrane.
Card in use: 4 weeks
Not recommended
4
Apply R3/Washing Solution
Apply one drop R3/Washing Solution to the test hole. Allow the reagent to soak
into the membrane (approx. 20-30 seconds). Note! The droplet bottle should be held
vertically, about 1 cm above the membrane.
15...25°C
1 day
5
Read the result
Read the result within 5 minutes using the Reference Colour Chart (see
1 hour
"Interpretation of Results").
Storage not
recommended*
Sample material
Capillary blood, venous blood with or
without anticoagulant (heparin, citrate or
EDTA) can be used.
Internal quality control
The C+/Control Positive should be used
to confirm the efficacy of the reagents
and correct performance of the test. Test
this control according to the same pro-
cedure as for a patient sample.
Note! The measured value should be
within the acceptance limits stated on
the vial label.
(see page 3 for illustrations)
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