HemoCue Hb 301 Manual De Operación página 31

remains switched on. Upon passing the selftest, the dis-
play will show the HemoCue symbol and three flashing
dashes, indicating that the analyzer is ready to perform
a measurement. An error code will be displayed if the
selftest fails. If quality control checks are required for
regulatory reasons, contact HemoCue or your distributor
for current recommendations for controls. Please refer
to local guidelines for recommended frequency of use.
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, geographi-
cal, 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 demonstrat-
ed 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)
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 . The results given below in
4
"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 per-
formed during the analyzing period. Commercially availa-
ble controls at 3 different levels were used. The hemoglob-
in concentration was measured in duplicate twice a day,
morning and afternoon, during 20 consecutive days.
x
Con- N
g/dL
trol
level
1 400 7.3
2 400 13.2
3 400 17.2
Accuracy
The results of the comparison studies between the He-
moCue Hb 301 system and the International Council for
Standardization in Haematology method (ICSH)
marized 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
.
5
performed during the analyzing period.
Study N Min
g/
dL
1 700 1.6
Point-of-care studies
Point-of-care studies have been performed at three individ-
ual district health centers in primary care with both nursing
31
Within-run Total Preci-
Precision sion
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
are sum-
3
Max Regres- Correla-
g/dL sion line tion
coeffi-
cient (r)
23.0 Y = 0.984x 0.998
+ 0.113