HemoCue WBC DIFF, Operating Manual, Page: 68 / 84

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Intended Purpose/Intended Use
The HemoCue WBC DIFF system is an In-Vitro diagnostic system
designed for quantitative determination of white blood cells
(WBC) in capillary or venous whole blood. The system provides
values for a total white blood cell count and a differential count
including neutrophil count, lymphocyte count, monocyte count,
eosinophil count and basophil count.
The HemoCue WBC DIFF system is indicated for use in clinical
laboratories and for point of care testing in professional health
care settings on pediatric (≥ 3 months) and adult patients.
The HemoCue WBC DIFF Analyzer is only to be used with
HemoCue WBC DIFF Microcuvettes for measurement of a total
white blood cell count and a differential white blood cell count or
with HemoCue WBC Microcuvettes for measurement of a total
white blood cell count only.
IVD Medical Device Directive
The HemoCue WBC DIFF system complies with the IVD Medical
Device Directive 98/79/EC and carries the CE mark.
Principles of the Method/Procedure
Principle of the method
A hemolyzing agent lyses the red cells in the microcuvette and a
staining agent colours the white cells. Several images are taken of
the stained white cells and cells are classified. The number of cells
are counted by image analysis in the analyzer.
Principle of the procedure
The microcuvette is for single-use only and serves as a sample
container and reaction chamber. A blood sample of approximately
10 µL is drawn into the cavity by capillary action. The micro-
cuvette is placed in the analyzer and within <5 minutes the result
is obtained. The system is designed to establish agreement with:
• Manual method for the differential white blood cell count.
• Manual method for total white blood cell count.
No calibration is needed as the system is factory calibrated
Warning and Precaution
The microcuvettes are for In Vitro Diagnostic use only. Always
handle blood specimens with care, they may be infectious. Consult
local environment authorities for proper disposal. Always wear
protective gloves when handling blood specimens. The micro-
cuvettes are for single-use only. Do not analyse patient samples in
QC test mode.
Storage and Handling
Microcuvettes
The microcuvettes are to be stored at 15–35 °C (59–95 °F), <90%
non-condensing humidity. An unopened vial/capsule of micro-
cuvettes can be stored for a shorter period of time (4 weeks)
outside the specified storage conditions, down to 4 °C (39 °F) and
up to 50 °C (122 °F). Allow the microcuvettes to reach 18-30° C
(64-86 °F) before use. For
individually packaged microcuvettes :
once the wrapping of a single packaged microcuvette is opened it
shall be used within 10 minutes. For
microcuvettes packaged in
vial : once the seal of the vial is broken, the microcuvettes shall be
used within 3 months. Always keep the vial properly closed.
Use the microcuvettes prior to the expiry date which is printed on
the package. The microcuvettes should be stored in the original
package.
Analyzer
The analyzer can be stored at 4–50 °C (39–122 °F), <90% non-
condensing humidity for four weeks.
Allow the analyzer to reach ambient temperature before use.
Operating temperature
For optimal performance of the HemoCue WBC DIFF system, the
operating temperature should be:
Venous/capillary sample in EDTA tube: 18 - 30° C (64-86 °F),
<90% non-condensing humidity
Capillary sample from fingerstick: 18 - 25° C (64-77 °F), <90%
non-condensing humidity.
Specifications
GB