HemoCue Hb 301, Operating Manual

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Expected values
2
Children 11.0–14.0 g/dL (110–140 g/L, 6.8–8.7 mmol/L)
Woman 12.0–15.0 g/dL (120–150 g/L, 7.4–9.3 mmol/L)
Men 13.0–17.0 g/dL (130–170 g/L, 8.1–10.5 mmol/L)
Children, 2 years to teenage, gradually increase to adult values.
Due to a wide range of conditions (dietary, geographical, etc) which
affect normal values, it is recommended that each laboratory establish
its own normal range.
Measuring range
Displayed range: 0–25.6 g/dL (0–256 g/L, 0–15.9 mmol/L). The
method used in the HemoCue Hb 301 system has according to the
NCCLS document EP6 been demonstrated to be linear between
2–25 g/dL, (within 4 % difference in 2–5 g/dL and within 3 % difference
in 5–25 g/dL)
5 .
Limitations of the procedure
Refer to the HemoCue Hb 301 Microcuvettes package insert
1
.
Specific performance characteristics
Within-run and Total precision
Within-run and total precision was determined according to the NCCLS
Document EP5-A
4
. The results given below in ”Within-run precision”
and ”Total precision” come from 3 batches of HemoCue Hb 301
Microcuvettes, 5 HemoCue Hb 301 Analyzers and 5 operators. No
recalibration was performed during the analyzing period. Commercially
available controls at 3 different levels were used. The hemoglobin
concentration was measured in duplicate twice a day, morning and
afternoon, during 20 consecutive days.
Within-run
Precision Total Precision
Control
level N
x
g/dL
SD
g/dL
CV
% SD
g/dL
CV
%
1 400 7.3 0.059 0.82 0.066 0.91
2 400 13.2 0.106 0.80 0.122 0.92
3 400 17.2 0.135 0.78 0.152 0.88
Accuracy
The results of the comparison studies between the HemoCue Hb 301
system and the International Council for Standardization in Haematology
method (ICSH)
3 are summarized in the table below. The study was
performed on 3 batches of HemoCue Hb 301 Microcuvettes, 4 HemoCue
Hb 301 Analyzers and by 8 operators. No recalibration was performed
during the analyzing period.
Study N Min
g/dL Max
g/dL Regression
line Correlation
coefficient (r)
1 700 1.6 23.0 Y = 0.984x
+ 0.113 0.998