Expected Values; Measuring Range; Limitations Of The Procedure - HemoCue Hb 301 Manuel D'utilisation

Expected values

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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) .
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Limitations of the procedure

Refer to the HemoCue Hb 301 Microcuvettes package insert
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.
x
Control N
g/dL
level
1 400 7.3
2 400 13.2
3 400 17.2
Accuracy
The results of the comparison studies between the HemoCue Hb 301
system and the International Council for Standardization in Haematology
method (ICSH) are summarized in the table below. The study was
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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.
1 .
Study N Min
g/dL
1 700 1.6
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Within-run Total Precision
Precision
SD CV SD CV
g/dL g/dL
% %
0.059 0.82 0.066 0.91
0.106 0.80 0.122 0.92
0.135 0.78 1.152 0.88
Max Regression Correlation
g/dL line coefficient (r)
23.0 Y = 0.984x 0.998
+ 0.113