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Hematology Analyzer
Il Joong Park, MD, PhD; Sunhyun Ahn, MD; Young In Kim, MD; Seon Joo Kang, MD; Sung Ran Cho, MD, PhD
Table 1.
Parameter
Range of
Mean
Range of
CV, %
Median
CV, %
Manufacturer
Quoted CV, %
WBC, /lL
Hb, g/dL
RBC, 3106/lL
MCV, lm3
MCH, pg/cell
MCHC, g/dL
HCT, %
RDW, %
PLT, 3103/lL
MPV, lm3
PCT, %
PDW, %
GRA%, %
LYM%, %
MON%, %
GRA#, /lL
LYM#, /lL
MON#, /lL
4270~8430
10.7~15.1
4.24~5.06
74.93~96.49
23.81~30.41
30.55~32.02
33.68~48.41
12.19~15.88
191.75~379.8
7.39~9.90
0.17~0.31
35.69~40.61
42.92~84.28
11.96~51.82
3.76~9.77
2010~7100
1010~2770
210~630
1.25~1.91
0.71~1.22
0.93~1.76
0.42~1.14
0.86~1.23
0.89~1.44
0.99~1.82
1.23~1.49
2.32~3.99
1.36~2.59
3.43~5.53
0.96~2.66
0.95~2.48
2.31~7.65
8.27~21.90
1.47~3.33
2.74~8.07
8.33~22.6
1.58
0.84
1.28
0.54
1.07
1.24
1.37
1.37
3.33
1.82
4.42
1.60
1.82
3.97
14.58
2.17
4.44
14.75
3.4
2.4
2.2
2
3
7
10
Abbreviations: CV, coefficient of variation; GRA#, granulocyte count; GRA%, granulocyte percentage; Hb, hemoglobin concentration; HCT,
hematocrit; LYM#, lymphocyte count; LYM%, lymphocyte percentage; MCH, mean cell hemoglobin; MCHC, mean cell hemoglobin concentration;
MCV, mean corpuscular volume; MON#, monocyte count; MON%, monocyte percentage; MPV, mean platelet volume; PCT, plateletcrit; PDW,
platelet distribution width; PLT, platelet count; RBC, red blood cell count; RDW, red blood cell distribution width; WBC, white blood cell count.
Blood Samples
Blood samples drawn from 244 patients and 26 healthy adults
with informed consent were used for this study. Residual
K2EDTA-anticoagulated blood samples were taken from the
hematology laboratory of Ajou University Hospital, Suwon,
Republic of Korea, after routine testing was complete. The leftover
specimens were used for precision, linearity, stability, and method
comparison. K2EDTA- and K3EDTA-anticoagulated blood samples were taken from participants with their prior agreement, and
were used for evaluation of the difference by EDTA tube (K2/K3)
usage. We used K2EDTA plastic tubes (Becton Dickinson, Franklin
Lakes, New Jersey) and K3EDTA plastic tubes (Greiner Bio-One,
Monroe, North Carolina) as containers. All specimens were stored
at room temperature and were tested within 6 hours, except in the
case of sample stability testing. This study was performed under
the approval of the Ajou University Hospital Institutional Review
Board.
Precision
Within-run imprecision was established according to the H26A2 guideline.7 Twelve samples of various range were assessed by
analyzing them 31 times consecutively by LABGEOHC10.
1078 Arch Pathol Lab MedVol 138, August 2014
Linearity
Linearity for WBC, Hb, RBC, and PLT was evaluated according to
the EP6-A guideline.5 Briefly, we prepared 5 levels of analytes by
mixing, diluting, or concentrating blood samples. The prepared
samples were tested 4 times each and the linearity was obtained by
polynomial regression analysis for first-, second- and third-order
polynomials.
Carryover
Carryover for WBC, Hb, RBC, and PLT was assessed by following
the recommendation of the International Council for Standardization in Haematology8 and the H26-A2 guideline.7 Briefly, 3
consecutive analyses of a patient sample with high analyte
concentration (H1, H2, and H3) were followed by 3 consecutive
analyses of a patient sample with low analyte concentration (L1,
L2, and L3). Carryover (%) was calculated from the formula: 100 3
(L1L3)/(H3L3). This process was repeated 9 times and 95%,
97.5%, and 99% confidence intervals were calculated.
Table 2. Repeatability (A) and Device/Method Precision (B) of LABGEOHC10 Hematology Analyzera
Medium
Parameter
WBC, /lL
A
B
Hb, g/dL
A
B
Mean
7830
Low
CV, %
1.13
1.67
Mean
High
CV, %
3460
2.23
2.84
Mean
CV, %
18 980
Manufacturer
Quoted CV, %
0.75
1.46
3
3.4
12.43
0.70
0.99
5.47
0.90
1.64
16.54
0.46
0.90
2
2.2
4.45
1.10
1.21
2.45
1.55
1.51
5.42
1.01
1.09
2
2.2
MCV, lm3
A
B
91.55
0.48
0.86
70.09
0.30
0.97
101.62
0.23
0.67
1.7
2
HCT, %
A
B
40.75
1.17
1.37
17.16
1.52
1.82
55.13
0.98
1.10
RDW, %
A
B
15.53
1.25
1.18
14.63
0.92
1.29
19.68
1.19
1.33
2.5
3
3.41
3.62
87.83
7.01
7.10
500.88
2.16
2.27
6
7
8.7
10
RBC, 3106/lL
A
B
PLT, 3103/lL
A
B
215.5
MPV, lm3
A
B
13.22
1.20
1.51
12.78
2.82
2.92
13.49
0.76
1.24
GRA%, %
A
B
53.39
1.58
1.65
39.25
1.49
1.55
58.42
2.17
2.13
LYM%, %
A
B
37.54
2.75
9.08
34.25
3.82
3.93
53.39
1.22
1.19
5.87
9.25
10.06
7.33
8.76
11.43
7.37
5.89
5.59
MON%, %
A
B
Abbreviations: CV, coefficient of variation; GRA%, granulocyte percentage; Hb, hemoglobin concentration; HCT, hematocrit; LYM%, lymphocyte
percentage; MCV, mean corpuscular volume; MON%, monocyte percentage; MPV, mean platelet volume; PLT, platelet count; RBC, red blood cell
count; RDW, red blood cell distribution width; WBC, white blood cell count.
a
Samsung Electronics Co, Suwon, Korea.
Data Analysis
Table 3.
Linearity and Carryover for WBC, Hb, RBC, and PLT of LABGEOHC10 Hematology Analyzera
WBC, /lL
Linearity range
Carryover, %
Mean
95% CI
97.5% CI
99% CI
300~71 000
0.10
0.02~0.18
0.01~0.19
0.01~0.21
RBC, 3106/lL
Hb, g/dL
PLT, 3103/lL
0.1~23.3
0~8.34
3~1033
0.03
0.09~0.15
0.11~0.17
0.13~0.19
0.06
0.36~0.24
0.41~0.29
0.46~0.34
0.23
0.06~0.41
0.03~0.44
0.00~0.47
Abbreviations: CI, confidence interval; Hb, hemoglobin concentration; PLT, platelet count; RBC, red blood cell count; WBC, white blood cell count.
a
Samsung Electronics Co, Suwon, Korea.
Arch Pathol Lab MedVol 138, August 2014
Comparison of the blood count parameters (A through O) between the LABGEOHC10 (Samsung Electronics Co, Suwon, Korea) and the LH780
(Beckman Coulter Inc, Brea, California). Abbreviations: GRA#, granulocyte count; Hb, hemoglobin concentration; HCT, hematocrit; Low PLT, less
than 50 3 103/lL of platelet count; LYM#, lymphocyte count; MCH, mean cell hemoglobin; MCHC, mean cell hemoglobin concentration; MCV,
mean corpuscular volume; MON#, monocyte count; MPV, mean platelet volume; PCT, plateletcrit; PLT, platelet count; RBC, red blood cell count;
RDW, red blood cell distribution width; WBC, white blood cell count.
Comparison and Bias Estimation of Blood Cell Count Parameters Between the LABGEOHC10a and the LH780b
Table 4.
Parameter
WBC, /lL
Correlation
Coefficient
Computed Line
0.9987
Y 1.0100X 329
0.9989
Y 0.9746X 0.1837
0.9984
Y 1.0048X 0.0075
MCV, lm3
0.9720
Y 1.0715X 7.3817
0.9930
Y 0.9633X 5.189
GRA#, /lL
0.9954
Y 1.0338X 82
LYM#, /lL
0.9906
Y 0.9890X 44
MON#, /lL
0.9309
Y 0.7248X 47
Hb, g/dL
6
Decision
Point
5000
25 000
12
17
4
6
80
100
150
450
2000
10 000
1500
5000
1000
Acceptable
Bias
95% Confidence
Interval of Predicted Bias
Decisionc
6250
61250
60.24
60.34
60.12
60.18
61.6
62
67.5
622.5
6100
6500
675
6250
6100
345~213
290~130
0.157~0.085
0.303~0.193
0.001~0.024
0.001~0.044
2.534~0.795
0.893~0.422
5.731~5.089
17.835~4.849
145~116
108~405
84~36
206~9
267~189
B
A
A
A
A
A
B
A
A
A
B
A
B
A
C
Abbreviations: GRA#, granulocyte count; Hb, hemoglobin concentration; LYM#, lymphocyte count; MCV, mean corpuscular volume; MON#,
monocyte count; PLT, platelet count; RBC, red blood cell count; WBC, white blood cell count.
a
Samsung Electronics Co, Suwon, Korea.
b
Beckman Coulter Inc, Brea, California.
c
Decision about whether candidate method (LABGEOHC10) is a suitable replacement for current method (LH780); A: performance of the
LABGEOHC10 is equivalent to the LH780; B: Data do not show that the bias of the LABGEOHC10 is different from the acceptable bias; C: performance
of the LABGEOHC10 is not equivalent to the LH780.
The effect of EDTA tube (K2 versus K3) was analyzed by paired t
test and the sample stability by 1-way analysis of variance test. For
the method comparison and bias estimation, we computed 95%
confidence interval of predicted bias and compared it to internal
performance criteria.6
RESULTS
Precision
Within-run precision for normal and abnormal patient
sample results is shown in Table 1; results are shown to
satisfy the manufacturers specification for all of the
measured parameters. Repeatability and device/method
precision is shown in Table 2; results are shown to satisfy
the manufacturers specification for all of the measured
parameters, except for low PLT. No technologic problems
with the instrument occurred during the evaluation period
of 8 weeks.
Linearity
Linearity analysis for WBC, Hb, RBC, and PLT is shown in
Table 3; it showed nonsignificance for all nonlinear
coefficients for all 4 parameters measured.
Method Comparison and Bias Estimation
Results for the method comparison of the LABGEOHC10
with the LH780 are presented in the Figure. All parameters
showed r values .0.95 with the exception of MON# (r
0.9309), MCHC (r 0.3778), and MPV (r 0.9259). Results
for the bias estimation of the LABGEOHC10 with the LH780
are presented in Table 4.
Carryover
Minimal carryover (,1%) was observed for all the
parameters investigated (Table 3).
Stability During Storage
All parameters, except for the percentage and count of
monocytes, showed 24-hour long-term stability for normal
samples both at RT and at 48C. The MON% and MON#
Arch Pathol Lab MedVol 138, August 2014