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Performance Evaluation of Samsung LABGEOHC10

Hematology Analyzer
Il Joong Park, MD, PhD; Sunhyun Ahn, MD; Young In Kim, MD; Seon Joo Kang, MD; Sung Ran Cho, MD, PhD

 Context.The Samsung LABGEOHC10 Hematology Analyzer (LABGEOHC10) is a recently developed automated


hematology analyzer that uses impedance technologies.
The analyzer provides 18 parameters including 3-part
differential at a maximum rate of 80 samples per hour.
Objective.To evaluate the performance of the LABGEOHC10.
Design.We evaluated precision, linearity, carryover,
and relationship for complete blood cell count parameters
between the LABGEOHC10 and the LH780 (Beckman
Coulter Inc) in a university hospital in Korea according
to the Clinical and Laboratory Standards Institute guidelines. Sample stability and differences due to the anticoagulant used (K 2 EDTA versus K 3 EDTA) were also
evaluated.
Results.The LABGEOHC10 showed linearity over a wide

utomated blood cell counters have been routinely used


as cost-effective and valuable tools for the diagnosis
and evaluation of blood disorders. Currrently, point-of-care
testing is also becoming an important adjunct to hematology laboratory practice and is becoming widely available at
primary health care clinics and in general practice. Although
several hematologic tests, especially the measurement of
hemoglobin concentration, are appropriate for point-of-care
testing, other various hematologic tests are also required
within such settings for the delivery of effective point-ofcare testing.13 Nevertheless, small to medium-sized laboratories usually prefer hematology analyzers that require
minimal training for operation and deliver accurate test
results in laboratory conditions.
The Samsung LABGEOHC10 Hematology Analyzer (Samsung Electronics Co, Suwon, Korea) is a simple, compact,
automated hematology analyzer that had been designed for
Accepted for publication October 17, 2013.
From the Department of Laboratory Medicine, Ajou University
School of Medicine, Suwon, Republic of Korea.
The authors have no relevant financial interest in the products or
companies described in this article.
This study was supported by a research fund from Samsung
Electronics Company (Suwon, Korea).
Presented in part at the XXVth International Symposium on
Technological Innovations in Laboratory Hematology; May 2124,
2012; Nice, France.
Reprints: Sung Ran Cho, MD, PhD, Department of Laboratory
Medicine, Ajou University School of Medicine, San 5, Woncheondong, Yeongtong-gu, Suwon 443721, Republic of Korea (e-mail
sungran@ajou.ac.kr).
Arch Pathol Lab MedVol 138, August 2014

range and minimal carryover (,1%) for white blood cell,


hemoglobin, red blood cell, and platelet parameters.
Correlation between the LABGEOHC10 and the LH780
was good for all complete blood cell count parameters (R
. 0.92) except for mean corpuscular hemoglobin concentration. The bias estimated was acceptable for all
parameters investigated except for monocyte count. Most
parameters were stable until 24 hours both at room
temperature and at 48C. The difference by anticoagulant
type was statistically insignificant for all parameters except
for a few red cell parameters.
Conclusions.The accurate results achievable and
simplicity of operation make the unit recommendable for
small to medium-sized laboratories.
(Arch Pathol Lab Med. 2014;138:10771082; doi:
10.5858/arpa.2013-0439-OA)
small to medium-sized laboratories with limited laboratory
space. The analyzer is composed of an automatic analysis
area and supportive reagents (diluent, lysing reagent, and
cleaner) area and uses impedance technology for cell
counting and photometry for hemoglobin (Hb) assay. The
analyzer provides 18 parameters, including 3-part differential at a maximum rate of 80 samples per hour, with a
sample requirement of 25 ll of EDTA-anticoagulated blood.
This study was performed to evaluate the performance of
the LABGEOHC10 in terms of precision, linearity, carryover,
difference by anticoagulant used (K2EDTA versus K3EDTA),
stability during storage, and method comparison with the
LH780 (Beckman Coulter Inc, Brea, California). We followed
the Clinical and Laboratory Standards Institute (CLSI)
guidelines EP5-A2,4 EP6-A,5 EP9-A2,6 and H26-A27 for
evaluation of precision, linearity, and method comparison.
Importantly, after method comparison, we will be able to
interpret results and compare them to internal performance
criteria according to the EP9-A2 of the CLSI to determine
whether the candidate methods (LABGEOHC10) are suitable
replacements for current methods.
MATERIALS AND METHODS
Instrumentation and Parameters
The LABGEOHC10 weighs 13.5 kg, with dimensions of 344 mm
(width) 3 293 mm (depth) 3 390 mm (height). The analyzer
features a graphic color LCD module with a touch screen and builtin thermal printer module. Its internal memory is capable of storing
1000 records with full histograms and individual patient data. The
analyzer can be connected to a host computer through a USB port
Performance of Samsung LABGEOHC10 AnalyzerPark et al 1077

Table 1.

Within-Run Imprecision Results for Blood Samples

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.

and allows stored records to be archived or restored. The operation


of the analyzer requires minimal training of laboratory personnel.
The analyzer is capable of determining 18 parameters including
3-part differential; white blood cell count (WBC), hemoglobin
concentration (Hb), red blood cell count (RBC), mean corpuscular
volume (MCV), mean corpuscular hemoglobin (MCH), mean
corpuscular hemoglobin concentration (MCHC), hematocrit
(HCT), RBC distribution width (RDW), platelet count (PLT), mean
platelet volume (MPV), plateletcrit, platelet distribution width
(PDW), granulocyte percentage, lymphocyte percentage, monocyte
percentage (MON%), granulocyte count, lymphocyte count, and
monocyte count (MON#).

Calibration and Quality Control


The LABGEOHC10 and LH780 were calibrated according to the
manufacturers recommendations before the study started. Manufacturers quality control material was run on both instruments on a
daily basis during the entire study period.

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

Repeatability and device/method precision of LABGEOHC10 was


also established according to the EP5-A2 guideline.4 Three levels of
commercial quality control material (DiatroCont 3 Hematology
Control, Clinical Diagnostic Solutions Inc, Plantation, Florida) were
run in pairs, 2 times per day (with at least 5-hour intervals) for 25
operating days.

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.

Method Comparison (Correlation)


The LABGEOHC10 was compared with the LH780 for the
following parameters: WBC; the numbers and percentages of
granulocytes, lymphocytes, and monocytes; RBC; Hb; HCT; MCV;
MCH; MCHC; RDW; PLT; and MPV according to the EP9-A2.6
Briefly, each sample was measured in duplicates with both units,
and the data of 40 samples were selected to cover clinically relevant
ranges for each parameter. Another 24 samples with PLT less than
50 3 103/lL were used for an additional evaluation of low PLT.

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.

Stability During Storage


Samples from 10 healthy adults were used for the evaluation of
sample stability. Two sets of samples, which were drawn at the
same time, were analyzed 10 times at 0, 6, 12, and 24 hours after
blood collection, with 1 set stored at room temperature (RT) and
the other at 48C.
Performance of Samsung LABGEOHC10 AnalyzerPark et al

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.

Difference by Type of Anticoagulant


(K2EDTA Versus K3EDTA)

Data Analysis

We collected blood into 2 different EDTA tubes (K2EDTA and


K3EDTA) from 50 patients and analyzed them to evaluate the
difference of the results.

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

Data analysis was carried out by using Microsoft Excel 2007


(Microsoft, Redmond, Washington) and SPSS v11.0 (SPSS Inc,
Chicago, Illinois). We performed polynomial regression analysis for
first-, second-, and third-order polynomials for linearity access.5

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

Performance of Samsung LABGEOHC10 AnalyzerPark et al 1079

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.

1080 Arch Pathol Lab MedVol 138, August 2014

Performance of Samsung LABGEOHC10 AnalyzerPark et al

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

RBC, 310 /lL

0.9984

Y 1.0048X  0.0075

MCV, lm3

0.9720

Y 1.0715X  7.3817

PLT, 310 /lL

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

showed statistically significant differences even after only 6


hours at 48C, but were stable up to 6 hours and 12 hours,
respectively, at RT.
Difference by EDTA Tube (K2 Versus K3)
All parameters except Hb, RBC, and HCT showed no
statistically significant differences by the type of EDTA tubes
used. The difference of the 3 red cell parameters was
minimal (,1%) and the correlation between the different
tubes was excellent for Hb (r 0.997), RBC (r 0.992), and
HCT (r 0.993).
COMMENT
Despite the application of previously proven technology
to a commercial product, instruments of such critical
importance as hematology analyzers should be validated
technically before implementation in daily practice. The
automated LABGEOHC10 Hematology Analyzer is easy to
use and requires minimal training for operation. This study
showed that the analyzer provides reliable and comparable
results to instruments that are currently used in clinical
laboratories.912
Overall results of the repeatability and device/method
precision satisfied the manufacturers specifications, except
for low PLT. The coefficient of variation at low PLT was
slightly higher than the coefficient of variation claimed by
the manufacturer, though it was still acceptable according to
EP5-A2 specifications.4 The imprecision of automated
platelet counts in the thrombocytopenic range is a welldocumented problem.11,1315 The LABGEOHC10 showed an
overall good correlation with the LH780, except for MCHC.
The poor correlation of MCHC has also been previously
reported in the literature.9,11,12,16
We determined if the LABGEOHC10 is a suitable replacement for the LH780, even though the 2 analyzers are very
different in terms of their scale. The LABGEOHC10 showed
an acceptable bias for most parameters investigated.
Nonequivalence for MON# is thought to be due to the
difference between LH780 providing a 5-part differential
Performance of Samsung LABGEOHC10 AnalyzerPark et al 1081

and LABGEOHC10, a 3-part differential. Limitation of


LABGEOHC10 that provides 3-part differential and no flags
other than numerical flag (high or low) might require an
application of broader criteria for slide review.
Our study showed that most parameters were stable for at
least 24 hours at RT and at 48C while the monocyte count
was unstable at both RT and 48C, with an unexpectedly
shorter stability of refrigerated samples than for samples at
RT, and opposite directional change dependent on the
storage temperature, using the LAGBEOHC10. Imeri et al17
reported that the stability of CBC parameters varied not only
according to the investigated parameter but also according
to storage temperature and the measurement system used.
In addition, sample stability is substantially shorter than that
stated by the manufacturers of hematology analyzers.17,18
Therefore, laboratory physicians might need to validate
stability before the introduction of a new hematology
analyzer in their laboratories.
All parameters, except Hb, RBC, and HCT, did not show
statistically significant differences according to the different
EDTA tubes. In this study, we used spray-dried K2EDTA
plastic tubes and K3EDTA plastic tubes and therefore, the
previously reported dilution effect of K3EDTA can be
excluded.19 The lower MCV value of K3EDTA-anticoagulated blood by RBC shrinkage, reported in the previous
studies,19,20 was not observed in this study. Although Hb,
RBC, and HCT were statistically significantly lower in
samples collected into K2EDTA tubes than in those collected
into K3EDTA tubes, they showed excellent correlation
between tubes. The differences of these parameters were
minimal (,1%) and were not likely to be of any clinical
relevance.
In conclusion, the overall performance of the LABGEOHC10 is comparable to that of the LH780. The accurate
results and simplicity of operation make it recommendable
for small to medium-sized laboratories and applicable as a
back-up instrument in larger laboratories.
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Performance of Samsung LABGEOHC10 AnalyzerPark et al

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