Product Description - Axis-Shield NycoCard CRP Visual Mode D'emploi

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AVAILABLE PRODUCTS
REF 1114793 NycoCard ® CRP Visual
REF 1113002 NycoCard ® CRP Single Test
REF 1112999 NycoCard ® CRP Single Test
REF 1113117 NycoCard ® READER II
REF 1003668 Capillary tube holder
REF 1113060 Test tube rack (for 6 tubes)
REF 1113059 Mini-Pet stand
REF 1017483 Mini-Pet, 25 µL
REF 1036889 Mini-Pet, 50 µL
REF 1040711 Pipette tips, 2-200 µL
REFERENCES
1. Claus DR, Osmand AP, Gewurz H. Radioimmunoassay
of human C-reactive protein and levels in normal sera.
J Lab Clin Med 1976; 87: 120-8.
2. Kindmark C-O. The concentration of C-reactive protein
in sera from healthy individuals.
Scand J Clin Lab Invest 1972; 29: 407-11.
3. Urdal P. et al. Rapid immunometric measurement of
C-reactive protein in whole blood.
Clin Chem 1992; 38: 580-4.
4. Steen Dahler-Eriksen B. et al. Evaluation of a near-patient
test for C-reactive protein used in daily routine in primary
healthcare by use of difference plots.
Clin Chem 1997; 43: 2064-75.
48 tests
24 tests

PRODUCT DESCRIPTION

48 tests
Intended use
1 instrument
NycoCard ® CRP Visual is an in vitro
1 unit
test for the rapid determination of CRP
(C-reactive protein) in human whole blood.
1 unit
1 unit
Test principle
NycoCard ® CRP Visual is a solid phase,
1 unit
sandwich-format, immunometric assay.
1 unit
In the six test holes of the card there is a
membrane coated with immobilized
2x500 units
CRP-specific monoclonal antibodies. A
diluted and lysed sample is applied to one
of the test holes of the test card. When
the sample flows through the membrane,
the antibodies capture the C-reactive pro-
teins. CRP trapped on the membrane will
then bind the gold-antibody conjugate
added, in a sandwich-type reaction.
Unbound conjugate is removed from the
membrane with the washing solution. A
paper layer underneath the membrane
absorbs excess liquid. In the presence of
a pathological level of CRP in the sample,
the membrane appears red-brown with a
colour intensity proportional to the CRP
concentration of the sample. The result is
read semi-quantitatively by visual compa-
rison to the Reference Colour Chart.
Kit contents: 48 Tests
TC/Test Cards
Each card contains six test holes with an
underlying porous membrane coated
with monoclonal anti-CRP antibodies.
R1/Dilution Liquid
Borate buffer (pH 9.0) and detergents.
R2/Conjugate
Solution containing monoclonal anti-
CRP antibodies labelled with ultra-small
gold particles.
R3/Washing Solution
Phosphate buffered NaCl solution (pH
7.4) and detergents.
GB
C+/Control Positive 1 x 0.5 mL
Serum of human origin with added
purified CRP.
Capillary tubes 1 x 50 units
25 µL end-to-end glass capillaries with
Na-heparin.
Reference Colour Chart 1 unit
Plastic stick with coloured zones indica-
ting five CRP levels from 10 to 200 mg/L.
For visual interpretation of results.
Plastic bags 2 x 1 unit
One for storing the card in use, and one
for storing the remaining card.
Material required
(not supplied with the kit)
- Pipette (25 µL) and pipette tips.
- Capillary tube holder.
Warnings and precautions
- For in vitro diagnostic use.
- Do not mix components from different
kit containers.
- Do not use test kits after the expiry date.
- The reagents and the C+/Control Positive
contain sodium azide in concentrations
< 0.1% as a preservative. Sodium azide
is a toxic agent. Avoid contact with eyes
and skin. Flush abundantly with water
upon disposal if reagents are spilled.
- R1/Dilution Liquid contains detergents
4 x 2 units
that are irritating to eyes and skin. Flush
with water if spilled or in contact with skin.
- The C+/Control Positive is produced
from blood collected from voluntary blood
2 x 26 x 1 mL
donors to Scandinavian blood banks.
Each unit is separately controlled and
1 x 3.5 mL
found negative for hepatitis B
S
gen, hepatitis C antibodies and HIV I &
II antibodies. However, universal pre-
cautions (treating all human source
1 x 3.0 mL
materials as if they were potentially
infectious) should be exercised.
anti-
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