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 . The results given below in "Within-run precision"
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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.
Control N
level
1 400
2 400
3 400
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
.
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during the analyzing period.
Study N Min
g/dL
1 700 1.6
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Within-run Total Precision
Precision
x
SD CV SD
g/dL g/dL g/dL
%
7.3 0.059 0.82 0.066
13.2 0.106 0.80 0.122
17.2 0.135 0.78 0.152
Max Regression Correlation
g/dL line coefficient (r)
23.0 Y = 0.984x 0.998
+ 0.113
CV
%
0.91
0.92
0.88