HemoCue Glucose 201 RT, Operating Manual

Page: 53 / 104

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Specific performance characteristics
Repeatability and within-laboratory precision
Repeatability and within-laboratory precision was determined
according to the CLSI Document EP5. The results given below
in “Repeatability” and “Within-laboratory precision” come
from 2 batches of HemoCue Glucose 201 RT Microcuvettes,
10 HemoCue Glucose 201 RT Analyzers and 6 operators.
Commercially available controls at 3 different levels were
used. The glucose concentration was measured in duplicate
twice a day, morning and afternoon, during 20 working days.
Repeatability Within-laboratory
precision
Control
level
N Mean
mg/dL
(mmol/L)
SD
pooled
mg/dL
(mmol/L)
CV
%
SD
pooled
mg/dL
(mmol/L)
CV
%
1 800 45.9 (2.5) 1.15 (0.064) 2.5 1.28 (0.071) 2.8
2 800 101.8 (5.7) 1.36 (0.075) 1.3 1.62 (0.090) 1.6
4 800 305.7 (17.0) 3.26 (0.180) 1.1 3.72 (0.210) 1.2
Validation Studies
Results of the validation studies, based on the intended use
of the system, are shown in Figure 1. Single replicate on the
HemoCue Glucose 201 RT system and the mean of duplicate
on the comparative method are presented in the plots. All
results are in whole blood.
Figure 1
Users Performance Evaluation
Point-of-Care
Capillary samples
Coefficients:
y
0
= 2.152
a = 1.002
r
2
= 0.995
n = 102
G
lu
co
se 2
01 R
T, 1
st r
ep
l (
m
g
/d
L)
YSI 2300 STAT Plus, mean values (mg/dL)