For veterinary use of the HemoCue WBC system HemoCue WBC Microcuvettes

For veterinary use of the HemoCue WBC system HemoCue WBC Microcuvettes
GB/US
For veterinary use of the HemoCue WBC system
HemoCue® WBC Microcuvettes
The system consists of the HemoCue WBC Analyzer
together with HemoCue WBC Microcuvettes. Please
read the Operating Manual for proper use of the
system1.
Intended Purpose/Intended Use
The HemoCue WBC system is indicated for use
for quantitative determination of white blood cell
(WBC) count in capillary or venous whole blood. The
HemoCue WBC system is for In Vitro Diagnostic use
only. The HemoCue WBC Analyzer is only to be used
with HemoCue WBC Microcuvettes.
Principles of the Method/Procedure
Principle of the Method
A hemolyzing agent lyses the red cells in the
microcuvette and a staining agent colors the white
cells. An image is taken of the stained white cells and
the number of cells is counted by image analysis in the
analyzer.
Principle of the Procedure
The microcuvette serves as a sample container and
reaction chamber. The microcuvette is for single-use
only. A blood sample of approximately 10 µL is drawn
into the cavity by capillary action. The microcuvette
is placed in the analyzer. The result is obtained within
3 minutes. The system was designed and developed to
establish agreement with the manual light microscopy
method for white blood cell count. The system is
factory calibrated and needs no further calibration.
Composition
The microcuvette is made of polystyrene plastic and
contains the following reagent: <20 µg/g cuvette
methylene blue, <500 µg/g cuvette saponin, <400 µg/g
cuvette Surfynol 465, <400 µg/g cuvette Triton X-100.
Warning and Precautions
The microcuvettes are for In Vitro Diagnostic use only.
Always handle blood specimens with care as they may
be infectious. Consult local environment authorities for
proper disposal. Always wear protective gloves when
handling blood specimens. The microcuvettes are for
single-use only.
Storage and Handling of
the HemoCue WBC Microcuvettes
The microcuvettes are to be stored at 15–35 °C
(59–95 °F), < 90 % non-condensing humidity. Once
the seal of the vial is broken, the microcuvettes are
stable for 3 months. An unopened vial of microcuvettes
can be stored for a shorter period of time (4 weeks)
outside the specified storage conditions down to 0°C
(32°F) and up to 50°C (122°F), < 90 % non-condensing
humidity. Allow the microcuvettes to reach 15–35 °C
(59–95 °F) before use. Use the microcuvettes prior to
the expiration date that is printed on the package. Keep
the vial properly closed. All unused microcuvettes
should remain in the original package.
Specimen Collection and Preparation
Capillary or venous whole blood may be used. Mix all
specimen tubes thoroughly on a mechanical mixer for
at least 2 minutes or invert the tube 10–20 times by
hand. The specimen can be stored at room temperature
(15–35 ºC, 59–95 ºF), or in a refrigerator (2–8 ºC,
35–46 ºF) for 48 hours. If the specimen has been stored
in a refrigerator, it will be viscous and the blood should
be allowed to warm up to room temperature before
mixing.
Procedure
Collect the blood sample according to normal
procedures. Venous or capillary samples can be used.
When collecting blood in tubes with anticoagulantia,
make sure to fill the tubes with the correct amount of
blood, and mix the samples thoroughly.
Note: For canine blood only use blood without
additives. Make sure to measure the sample directly in
order to avoid coagulation.
Please read the Operating Manual for proper use of the
system1.
Limitations of the Method
a) The measurement should be made as soon as
possible, but within 40 seconds after the blood has
been drawn into the microcuvette.
b) Do not remeasure the filled microcuvette.
c) Mixing samples for an extended period may affect
the result.
d) Results above the measuring range will be displayed
as HHH. Results below the measuring range will be
displayed as LLL.
e) Studies have shown that patient samples with
>2 % nucleated red blood cells (NRBCs) may give
falsely ­elevated white blood cell count.
For specific performance characteristics, please refer to
the ­Operating Manual1.
Bibliography
1. HemoCue WBC Operating Manual
Symbols Used
Caution
Opened
Do not reuse
Consult instructions
for use
CE mark
Temperature limits
Date of opening
Use by
(Year Month Day)
Catalog number
Batch code
Open vial expiry date.
Must not exceed the
“Use by” date.
The product is
protected by the
following patents
(or Patent Pending)
Manufacturer
HemoCue AB
Box 1204
SE-262 23 Ängelholm
Sweden
Phone +46 775 70 02 10
Fax
+46 775 70 02 12
E-mail info@hemocue.se
www.hemocue.com
1530xx   091124 GB_US
HemoCue Distributor USA
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