introduction of products · 1) name: automated hematology analyzer xn-l series 2) model: xn-550...

Sysmex Journal International Vol. 25 No. 1 (2015)

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INTRODUCTIONIn recent years, healthcare infrastructures have beensteadily constructed in emerging markets. In addition,rapid rates of economic growth have made healthcareinformation more accessible worldwide.Thus, people have become more aware of health andhealthcare, with dramatically increasing demands formedical care and clinical testing. In developed countries,regional needs have diversified, such as medical costsuppression due to the aging society and widely-spreading personalized healthcare.To address the dynamic healthcare terrain, we launchedthe XN-Series in 2011, which improved the efficiencyand clinical values of blood cell count testing. Now weintroduce the XN-L series; compact automatedhematology analyzers that are based on XN seriesfunctionality, operability, and clinical parameters 1-3) (Fig. 1).These analyzers are among the world's smallest and are

equipped with advanced testing modalities includingreticulocyte (RET) measurement functions, a low WBCmode, and body fluid mode. The XN-L also has thefeatures of conventional products including: 8 CBCparameters, 6 WBC classifications, and trace analytemeasurement. This series includes superior service andsupport systems that correspond to the Sysmex NetworkCommunication Systems (SNCS®) 4), contributing to safeand efficient laboratory test environments. One analyzerin this line, the XN-550, features automatedRerun/Repeat/Reflex functions as an added capability.Furthermore, this product line is already equipped toprovide future enhancements, including an optionalapplication to detect the infected erythrocytes in malarialinfection, which is one of the three most prevalentinfections worldwide. Sysmex is committed to advancinghematology technologies in order to further develop theclinical use of the automated blood cell analyzer. In thisreport, XN-L series will be introduced.

OverOverview and Features of the Automated Hematology Analyzerview and Features of the Automated Hematology Analyzer

XN-L Series

Overview and Features of the Automated Hematology Analyzer

XN-L Series

Introduction of Products

Yoshikoshiko Ho HAMAAMAGUCHIGUCHI*1*1, , Tamiaki Kamiaki KONDOONDO*1*1, Rie N, Rie NAKAIAKAI*1*1, , Yasuhiro Oasuhiro OCHICHI*1*1, , Tomonoromonori Oi OKAZAKIKAZAKI*2*2,

KinKinya Ua UCHIHASHICHIHASHI*2*2, , Takashi Makashi MORIKAORIKAWA*1*1

*1*1 Scientific Aff Scientific Affairsairs, Sysme, Sysmex Corx Corporporation, 1-3-2 Murotani, Nishi-ku, Kation, 1-3-2 Murotani, Nishi-ku, Kobe 651-2241, Jobe 651-2241, Japanapan*2*2 Hematology Product Engineer Hematology Product Engineering Division, Sysmeing Division, Sysmex Corx Corporporationation

Yoshiko HAMAGUCHI*1, Tamiaki KONDO*1, Rie NAKAI*1, Yasuhiro OCHI*1, Tomonori OKAZAKI*2,

Kinya UCHIHASHI*2, Takashi MORIKAWA*1

*1 Scientific Affairs, Sysmex Corporation, 1-3-2 Murotani, Nishi-ku, Kobe 651-2241, Japan*2 Hematology Product Engineering Division, Sysmex Corporation

Note: This article is translated and republished from Sysmex Journal Web Vol. 16 No. 1 2015.


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Table 1 Reportable parameters

MAIN SPECIFICATIONS

1. Name

1) Name: Automated Hematology Analyzer XN-L series2) Model: XN-550 (Sampler type)

XN-450 (Cap-piercing type)XN-350 (Open type)

2. Applications

These devices are hematology analyzers for blood testingusing human blood. Blood should be anticoagulated withEDTA-2K, EDTA-3K, and EDTA-2Na for use on theanalyzers. Body fluids, such as cerebrospinal, pleural,peritoneal, and synovial fluids, can also be measured.

3. Reportable parameters

There are 35 reportable whole blood parameters and 7reportable body fluid parameters. For details, see Table1.

4. Main research parameters

Fragmented red blood cell count (FRC#), fragmented red

blood cell ratio (FRC%), high fluorescent lymphocytecount (HFLC#), and high fluorescent lymphocyte ratio(HFLC%).

5. Sample volume

Sample volumes to be aspirated are 25µL and 70µL forwhole blood and diluted blood/body fluid, respectively.For details, see Table 2.

6. Throughput

Throughput is up to approx. 70 samples per hour. Fordetails, see Table 3.

7. Dimensions and weight

Dimensions (width × depth × height) and weights areshown in Table 4.

8. Reagents

Reagents and their measurement channels are shown inTable 5.

CBC

Discrete

* The availability of functions depends on the system configuration.

Analysis Mode

Whole Bloodmode

Body Fluid mode*

Detector/Channel Parameter

DIFF

RET

WDF

RET*

RBC, WDF

WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT

RDW-SD, RDW-CV, PDW, MPV, P-LCR, PCT

NEUT#, LYMPH#, MONO#, EO#, BASO#, NEUT%,

LYMPH%, MONO%, EO%, BASO%, IG#, IG%

RBC-BF, WBC-BF, MN#, PMN#, MN%, PMN%, TC-BF—

RBC/PLT, HGB, WDF

RET#, RET%, IRF, LFR, MFR, HFR, RET-He, IPF#, IPF


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25µL

25µL

25µL

70µL*1

70µL

70µL

1mL

250µL

1mL

300µL

250µL

100µL

300µL

140µL

1mL

300µL

140µL

XN-550/XN-450

XN-350

*1: Use diluted blood prepared by diluting 20µL of whole blood1:7.*2: The availability of body fluid analysis function depends on the system configuration.

Analysis method

Sampler analysis(XN-550)

Manual analysis

Manual analysis

Specimen

Specimen

Wholeblood

Whole blood

Wholeblood

Dilutedblood

Diluted blood

Bodyfluid*2

Body fluid*

Test tube

Test tube

Regular sample tube

Regular sample tube

RBT micro collection tube

Regular sample tube

RBT micro collection tube

Micro collection tube

Regular sample tube

Regular sample tube



Cap

Cap

Close

Close

Close

Open

Close

Open

Open

Open

Close

Open

Open

Open

Aspirated sample volume

Aspirated sample volume

Required sample volume

* The availability of body fluid analysis function depends on the system configurations.

Analysis method

Table 2 Sample volume

Table 3 Throughput

*1: The throughput depends on the system configuration.*2: The availability of functions depends on the system configurations.

Analysis mode

Whole blood

Low WBC*2

Pre-Dilution

Body fluid*2 —

Discrete Throughput

Approx. 60 samples/hour (approx. 70 samples/hour*1)

Approx. 35 samples/hour






CBC

CBC

CBC+DIFF

CBC+DIFF

CBC+DIFF

CBC+RET*2

CBC+DIFF+RET*2

CBC+DIFF+RET*2

CBC+DIFF+RET*2

TECHNOLOGY

1. Measurement principles

1) Flow cytometryThe XN-L uses reliable flow cytometry technology usinga semiconductor laser which inherits the technology ofXN-Series 4) to provide high-performance measurementsin a compact design. Blood cells are treated with specificreagents, and are expanded on multi-dimensionalscattergrams through the conversion of forward scattered-, side scattered-, and side fluorescent light into electricalimpulses. Each scattergram is analyzed using originaltechnologies to calculate measurements (Table 6). Thelow WBC and body fluid modes improve accuracy byincreasing the amount of blood cells counted. Also,reticulocyte hemoglobin equivalents (RET-He) andimmature platelet fraction (IPF) are determined.

2) Hydro dynamic focusing method (direct current:DC detection method) 5)

Red blood cell and platelet counts are determined usingHydro dynamic focusing method. In principle, thecoincidence and recount of blood cells are minimized,facilitating accurate measurements of blood counts andvolumes.

3) SLS hemoglobin method 6)

Hemoglobin concentrations are determined by the SLShemoglobin method without using toxin or specialoxidizing agents.

In principle, blood cells are lysed with sodium laurylsulfate (SLS), followed by colorimetric measurements.This method is suitable for automation.

2. Body fluid mode 1)

The devices are equipped with a body fluid mode.Without sample pretreatment, white blood cell (WBC-BF) and red blood cell (RBC-BF) counts as well asmononuclear (MN#, MN%) and polymorphonuclear(PMN#, PMN%) leukocyte ratios can be determined andreported. The measurement accuracy is improved byincreasing the particle counts approximately tenfold inwhite blood cells and threefold in red blood cells, whencompared to the whole blood mode.

3. Low WBC mode 2,3)

The devices are equipped with a low WBC mode,facilitating the accurate determination of low WBCcounts. In principle, sample volume to be measured isdoubled, as compared with the whole blood mode,thereby improving the measurement accuracy.

4. Automated dispensing function of diluent

The devices dispense 120µL of CELLPACK DCL into anempty micro collection tube. Subsequently, diluted bloodprepared with 20µL of sample can be measured. Thisfacilitates the measurement of small blood volumeswhich is especially useful for patient populationsincluding geriatric and infant.


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Table 4 Dimensions and weight

Table 5 Reagents

XN-550

XN-450

XN-350

AnalyzerMonitor

Analyzer

Analyzer

Dimensions (width × depth × height)

Approx. 450 × 660 × 450 mmApprox. 267 × 205 × 240 mm

Approx. 450 × 460 × 440 mm

Approx. 450 × 460 × 510 mm

Weight

Approx. 53 kgApprox. 3 kg

Approx. 35 kg

Approx. 35 kg

*1: Use of CELLPACK DST depends on the system configuration.*2: The availability of functions depends on the system configurations.

Channel

Each channel

HGB channel

WDF channel

RET channel*2

Reagent type

Diluent (concentrated reagent)

Diluent

Hemolytic agent

Hemolytic agent

Stain solution

Diluent

Stain solution

Product name

CELLPACK DST*1

CELLPACK DCL

SULFOLYSER

Lysercell WDF

Fluorocell WDF

CELLPACK DFL

Fluorocell RET

BASIC PERFORMANCE

1. Within-run reproducibility1) Whole blood modeWithin-run reproducibility was demonstrated using threeblood samples from healthy volunteers each with 10-consecutive measurements in whole blood mode. Resultsare shown in Table 7. The CV values of main parameterswere WBC : 1.3 - 2.0%, RBC : 0.3 - 0.7%, HGB : 0.3 -0.5%, HCT : 0.2 - 0.8%, PLT-I : 2.0 - 2.2%, and PLT-O :0.8 - 2.1%.

2) Body fluid modeWithin-run reproducibility in body fluid mode wasdemonstrated by preparing samples in three differentconcentrations using quality control material (XNCHECK BF) and measuring each in 10-consecutive runs.This data is shown in Table 8. The CV values of mainparameters were WBC-BF : 5.6 - 9.3%, RBC-BF : 2.4 -10.6% , and TC-BF# : 5.6 - 9.3%.

2. Correlation1) Whole blood modeA correlation between XN-550 (XN-L series) and XN-1000 (XN-Series) in the whole blood mode using patient blood samples (EDTA-2K added, N = 106, provided by the Improvement for Measurement and Diagnostic Technique Project at Department of Laboratory Tests, University of Tsukuba Hospital, Japan) is shown in Fig. 2. The correlation coefficients (r) of main parameters were WBC : 0.9974, RBC : 0.9984, HGB : 0.9987, HCT : 0.9976, and PLT : 0.9982.

2) Body fluid modeA correlation between XN-550 (XN-L series) and XN-1000 (XN-Series) using 20 celomic fluid, 12 cerebrospinal fluid, and 23 peritoneal dialysate in the body fluid mode is shown in Fig. 3. The correlation coefficients (r) of each parameterwas WBC-BF : 0.9994, RBC-BF : 0.9995, and TC-BF# :0.9993.

3. Minimum detection sensitivity1) Whole blood modeMinimum sensitivities (limit of blank : LoB, limit ofdetection : LoD, and limit of quantitation : LoQ) inmeasuring a quality control material (e-CHECK) forwhich the concentration has been adjusted andCELLPACK DCL in the whole blood mode are shown inTable 9. The minimum detection sensitivities of mainparameters were WBC (CBC + DIFF mode) : 0.01 ×109/L, RBC : 0.00 × 1012/L, and PLT : 1 × 109/L.

2) Low WBC modeMinimum sensitivities (LoB, LoD, and LoQ) inmeasuring a quality control material (e-CHECK) forwhich the concentration has been adjusted andCELLPACK DCL in the low WBC mode are shown inTable 10. The minimum detection sensitivities of mainparameters were WBC : 0.01 × 109/L, RBC : 0.00 ×1012/L, and PLT : 1 × 109/L.

3) Body fluid modeMinimum sensitivities (LoB, LoD, and LoQ) inmeasuring a quality control material (e-CHECK) forwhich the concentration has been adjusted andCELLPACK DCL in the body fluid mode are shown inTable 11. The minimum detection sensitivities of mainparameters were WBC-BF : 0.001 × 109/L, RBC-BF :0.000 × 1012/L, and TC-BF# : 0.001 × 109/L.


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Table 6 Measurement channels and detection parameters

WDF

RET*

Detection parameters

Forward scattered light - side scattered light (CBC)

Side scattered light - side fluorescence light (CBC + DIFF)

Side fluorescence light - forward scattered light

Channel Detection parameters

White blood cell count

WBC 6 differentiation for white blood cell

Reticulocyte

* The availability of functions depends on your system configurations.


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Table 7 Within-run reproducibility of the whole blood mode

AVE.

SD

CV

AVE.

SD

CV

AVE.

SD

CV

1

2

3

WBC-C*1

(109/L )

6.948

0.140

2.0%

9.091

0.117

1.3%

3.661

0.046

1.3%

WBC-D*2

(109/L )

6.915

0.138

2.0%

9.012

0.114

1.3%

3.638

0.048

1.3%

RBC(1012/L )

5.206

0.014

0.3%

5.014

0.035

0.7%

4.783

0.030

0.6%

HGB(g/L )

162.7

0.7

0.4%

148.0

0.7

0.5%

154.2

0.4

0.3%

HCT(L/L )

0.5020

0.0012

0.2%

0.4682

0.0035

0.8%

0.4672

0.0030

0.7%

MCV(fL)

96.43

0.07

0.1%

93.38

0.15

0.2%

97.68

0.11

0.1%

MCH(pg)

31.25

0.16

0.5%

29.52

0.23

0.8%

32.25

0.22

0.7%

MCHC(g/L )

324.1

1.9

0.6%

316.0

2.6

0.8%

330.1

2.1

0.6%

PLT-I(109/L )

312.1

6.2

2.0%

259.6

5.6

2.2%

174.5

3.8

2.2%

PLT-O(109/L )

298.2

2.3

0.8%

250.6

4.1

1.6%

170.6

3.7

2.1%

AVE.

SD

CV

AVE.

SD

CV

AVE.

SD

CV

1

2

3

NEUT%(%)

56.59

0.82

1.5%

74.78

0.51

0.7%

44.86

0.69

1.5%

LYMPH%(%)

34.51

0.91

2.6%

14.19

0.52

3.6%

46.58

0.78

1.7%

MONO%(%)

5.48

0.22

4.0%

8.56

0.45

5.2%

6.49

0.40

6.1%

EO%(%)

2.89

0.22

7.6%

2.07

0.17

8.2%

1.50

0.29

19.4%

BASO%(%)

0.53

0.14

26.8%

0.40

0.09

23.6%

0.57

0.15

26.2%

RET%(%)

2.437

0.055

2.3%

1.966

0.053

2.7%

1.086

0.061

5.6%

RET#(109/L )

126.87

2.74

2.2%

98.57

2.67

2.7%

51.94

2.79

5.4%

RET-He(pg)

33.11

0.06

0.2%

32.60

0.09

0.3%

33.96

0.19

0.6%

*1 WBC-C: The total white blood cell count measured from the forward scattered light and side scattered light of WDF channel (CBC mode).*2 WBC-D: The white blood cell count measured from the WDF channel (CBC + DIFF mode).

Table 8 Within-run reproducibility of the body fluid mode

AVE.

SD

CV

MAX

MIN

AVE.

SD

CV

MAX

MIN

AVE.

SD

CV

MAX

MIN

1

2

3

WBC-BF(109/L )

0.0104

0.0008

8.1%

0.012

0.009

0.0211

0.00209.3%

0.025

0.018

0.0464

0.00265.6%

0.050

0.043

RBC-BF(1012/L )

0.0066

0.000710.6%

0.0080.0060.0118

0.0006

5.4%

0.013

0.0110.0268

0.0006

2.4%

0.028

0.026

TC-BF(109/L )

0.0104

0.0008

8.1%

0.012

0.009

0.0211

0.00209.3%

0.025

0.018

0.0464

0.00265.6%

0.050

0.043


− 7 −

Fig. 2-1 Correlations among CBC 8 parameters

y = 1.0094x -0.1048r = 0.9974n = 106

WBC (109/L )

0

5

10

15

20

25

0

XN-5

50

XN-1000

01 51 02 525

y = 0.9987 x+ 0.03r = 0.9984n = 106

RBC (1012/L )

0.0

2.0

4.0

6.0

8.0

0.0XN

-550

XN-1000

8.06.04.02.0

y = 0.9878 x+ 0.7966r = 0.9987n = 106

HGB (g/L )

0

50

100

150

200

0

XN-5

50

XN-1000

20015010050

y = 0.9793x + 0.0076r = 0.9976n = 106

HCT (L/L )

0.0

0.2

0.4

0.6

0.0

XN-5

50XN

-550

XN-1000

0.60.40.2

y = 1.0375x -3.9786r = 0.9946n = 106

MCV (fL)

60

80

100

120

140

XN-5

50

XN-1000

14012010006 08

y = 0.9695 x+ 0.0565r = 0.9900n = 106

MCH (pg)

15

25

35

45

15

XN-5

50

XN-1000

453525

y = 0.9627 x+ 0.0286r = 0.9982n = 106

PLT (10 9/L)

0

200

400

600

800

1,000

XN-5

50

XN-1000XN-1000

1,000002 004 006 0080


− 8 −

Fig. 2-2 Correlations among analytical parameters

y = 0.9529 x+ 1.0553r = 0.9910n = 106

RDW-SD (fL)

30

40

50

60

70

80

XN-5

50

XN-100003 04 05 06 07 08

y = 0.9673 x+ 0.3215r = 0.9976n = 106

RDW-CV (%)

10

15

20

25

30

XN-5

50

XN-100001 51 02 52 03

y = 0.8543 x+ 1.4693r = 0.9428n = 105

PDW (fL)

5

10

15

20

XN-5

50

XN-10002015105

y = 0.9526 x+ 0.3205r = 0.9577n = 105

MPV (fL)

6

8

10

12

14

16

XN-5

50

XN-100001 21 41 6186

y = 0.9265 x+ 0.4405r = 0.9766n = 105

P-LCR (%)

0

20

40

60

XN-5

50

XN-10006040200

y = 0.9613x -0.0032r = 0.9949n = 105

PCT (% )

0.0

0.2

0.4

0.6

0.8

1.0

XN-5

50

XN-10000.0 2.0 4.0 6.0 8.0 0.1

y = 0.9764x + 1.2967r = 0.9959n = 106

NEUT% (%)

0

20

40

60

80

100

120

XN-5

50

XN-100002 04 06 08 001 0210

y = 0.984 x+ 0.5881r = 0.9952n = 106

LYMPH% (%)

0

20

40

60

80

0

XN-5

50

XN-100002 04 06 08

y = 0.9651x + 0.2871r = 0.9774n = 106

MONO% (%)

XN-5

50

0

10

20

30

40

0XN-1000

01 02 03 04

y = 0.9604 x+ 0.0875r = 0.9933n = 106

EO% (%)

0

5

10

15

20

25

30

0

XN-5

50

XN-100001 51 02 52 035

y = 0.6356 x+ 0.2632r = 0.6717n = 106

BASO% (%)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

0.0

XN-5

50

XN-10005.0 0.1 5.1 0.2 5.2 0.3

y = 0.852 x-0.1624r = 0.9851n = 106

IG% (%)

0

5

10

15

0

XN-5

50

XN-100015105

Fig. 2-3 Correlations among WDF channel parameters


− 9 −

Fig. 2-4 Correlations among RET channel parameters

y = 1.0754 x+ 0.6081r = 0.9768n = 106

IRF (%)

0

10

20

30

40

50

60

0

XN-5

50

XN-1000

01 02 03 04 05 06

y = 1.1474 x+ 0.1421r = 0.9833n = 106

HFR (%)

0

10

20

30

0

XN-5

50

XN-1000

302010

y = 0.9835 x+ 1.1739r = 0.9354n = 106

MFR (%)

0

5

10

15

20

25

30

0

XN-5

50

XN-1000

01 51 02 52 035

y = 1.0754x -8.1507r = 0.9768n = 106

LFR (%)

40

60

80

100

120

40

XN-5

50

XN-1000

12010006 08

y = 1.0005 x+ 0.0092r = 0.9963n = 106

RBC-O (1012/L)

0

2

4

6

8

0 2 4 6 8

XN-5

50

XN-1000

y = 1.0455x + 2.7218r = 0.9972n = 106

PLT-O (10 9/L)

0

200

400

600

800

1,000

1,200

0

XN-5

50

XN-1000

1,2001,000800600400200

y = 1.2209 x+ 0.7131r = 0.7779n = 106

IPF (%)

0

5

10

15

20

0

XN-5

50

XN-1000

01 51 025

y = 0.9794x + 0.3284r = 0.9908n = 106

RET-He (pg)

10

20

30

40

50

XN-5

50

XN-1000

01 02 03 04 05

y = 1.0176x -0.6837r = 0.9885n = 106

RET# (10 9/L)

0

50

100

150

200

250

0

XN-5

50

XN-1000

05 001 051 002 052

y = 1.037x -0.5976r = 0.9961n = 106

RET% (%)

0

3

6

9

12

15

0

XN-5

50

XN-1000

1512963


− 10 −

Fig. 3 Correlations among body fluid parameters

y = 1.0779x -0.0028r = 0.9977n = 55

PMN# (109/L )

0

2

4

6

8

10

0

X

N-5

50

XN-1000

108642

y = 1.0635x -0.0001r = 0.9997n = 55

MN# (109/L )

0

2

4

6

8

10

0

X

N-5

50

XN-1000

108642

y = 0.9591x+0.00004r = 0.9995n = 55

RBC-BF (1012/L )

0.00

0.02

0.04

0.06

0.08

0.10

0.00

X

N-5

50

XN-1000

0.100.080.060.040.02

y = 1.0722x -0.0059r = 0.9994n = 55

WBC-BF (109/L )

0

2

4

6

8

10

0

X

N-550

XN-1000

108642

y = 0.7236 x+ 21.398r = 0.7825n = 44

MN% (%)*

0

20

40

60

80

100

0

X

N-5

50

XN-1000

10080604020

y = 0.9088x + 2.6322r = 0.9000n = 44

PMN% (%)*

0

20

40

60

80

100

0

X

N-5

50

XN-1000

10080604020

y = 1.067x -0.0081r = 0.9993n = 55

TC-BF# (109/L )

0

2

4

6

8

10

0

X

N-5

50

XN-1000

108642

* MN% and PMN% parameters: N= 44, as samples not satisfying the LoQ (WBC-BF < 0.003 × 109/L) were excluded.

FEATURES

In spite of its small size, XN-L series can provide varioushealthcare information (RET, RET-He, and body fluidparameters) which may assist clinicians in diagnosticdecisions.RET-He reflects the hemoglobin levels in reticulocytesand is a sensitive indicator of iron utilization inerythropoiesis. Thus, it should facilitate the treatment andmanagement of anemia in patients with chronic kidneydisease 7) and improve the safety of autologous blooddonation 8).The XN-L series allows the measurements of white bloodcells, red blood cells, mononuclear cells, andpolymorphonuclear leukocytes in the body fluid mode.Thus, it allows users to make rapid and objective reportsof measurements from emergency tests at non-businesshours, as well as from daily practices. This feature shouldbe particularly useful in the diagnosis of central nervoussystem infection. In addition, it may be utilized as

screening information for cytology to detect tumor cells9).The XN-L series is also equipped with a PLT-I/PLT-Oswitching function. The impedance platelet count (PLT-I)comes from the hydro dynamic focusing method, whilethe optical platelet count (PLT-O) is measured in theRET channel using flow cytometry. Usually, the PLT-I isemployed as platelet count, while the PLT-O isautomatically reported as platelet count for samples withabnormal platelet particle size distributions, such as thosewith fragmented red blood cells 10).This function facilitates reporting of more reliableplatelet counts.In addition, with customers' analytical devices and ourcustomer support centers connected on-line, the XN-Lseries provides real-time quality control and faultmonitoring/repair support on the outsourcing basis, andSNCS® service function providing information on theweb 4, 11). More than 24,000 devices are connected on theweb around the world, facilitating reporting of accuratemeasurements and maintenance of devices.


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Table 9 Minimum detection sensitivity of the whole blood mode

Table 10 Minimum detection sensitivity of the low WBC mode

Table 11 Minimum detection sensitivity of the body fluid mode

LoB

LoD

LoQ

WBC-C(109/L )

0.01

0.02

0.03

WBC-D(109/L )

0.00

0.01

0.02

RBC(1012/L )

0.00

0.00

0.00

HGB(g/L )

0

0

0

HCT(L/L )

0.000

0.000

0.000

PLT-I(109/L )

0

1

2

PLT-O(109/L )

0

1

2

LoB

LoD

LoQ

WBC-C(109/L )

0.00

0.01

0.01

RBC(1012/L )

0.00

0.00

0.00

HGB(g/L )

0

0

0

HCT(L/L )

0.000

0.000

0.000

PLT-I(109/L )

0

1

2

PLT-O(109/L )

0

1

2

LoB

LoD

LoQ

WBC-BF(109/L )

0.000

0.001

0.002

RBC-BF(1012/L )

0.000

0.000

0.001

TC-BF#(109/L )

0.000

0.001

0.002

ADDITIONAL VALUES

Like XN-Series, the XN-L series also providesparameters such as immature granulocyte (IG) count andIPF.Studies have shown that IG may facilitate the detectionof inflammatory reaction easier and quicker whencombined with existing parameters, such as C-reactiveprotein and erythrocyte sedimentation rate 12).Reticulated platelet counts reflect the platelet productionability of the bone marrow. The XN-L series allowsautomatic measurement of its related parameter IPF. IPFhas been reported useful in predicting platelet recoverytime after chemotherapy or hematopoietic stem celltransplantation 13) and may aid clinicians in thedifferential diagnosis of thrombocytopenic disorders,such as immunological thrombocytopenia (e.g.,idiopathic thrombocytopenic purpura) 14).

CONCLUSIONS

This report introduced the newly released AutomatedHematology Analyzer XN-L series. Using many of thesame technologies as the higher throughput XN-series,these compact analyzers contribute to accuratemeasurement techniques and testing efficiency and canbe customized to fit the unique needs of each customer.In addition, it employs systems developable onward sothat the wide spread usage of hematology analyzers inclinical practice can be expected in future.

References1) Fleming C et al. Validation of the body fluid module on the new

Sysmex XN-1000 for counting blood cells in cerebrospinal fluidand other body fluids. Clin Chem Lab Med. 2012;50(10):1791-8.

2) Briggs C et al. Performance evaluation of the Sysmex haematologyXN modular system. J Clin Pathol. 2012 Nov;65(11): 1024-30.

3) Seo JY et al. Performance evaluation of the new hematologyanalyzer Sysmex XN-series. Int J Lab Hematol. 2015; 37(2): 155-64.

4) Ochi Y et al. Overview of the Automated Hematology AnalyzerXN-Series. Sysmex Journal 2011; 34(2): 1-16. (Japanese).

5) Fujimoto K. Principles of measurement in hematology analyzersmanufactured by Sysmex Corporation. Sysmex JournalInternational. 1999; 9(1): 31-44.

6) Oshiro I et al. New method for hemoglobin determination by usingsodium lauryl sulfate (SLS). Clinical biochemistry. 1982; 15(2):83-88.

7) Miwa N et al. Usefulness of measuring reticulocyte hemoglobinequivalent in the management of haemodialysis patients with irondeficiency. Int J Lab Hematol. 2010; 32(2):248-55.

8) Shibayama M et al. Usefulness of reticulocyte hemoglobinequivalent for the safety of pre-operative autologous blooddonation. Rinsho Byori. 2011; 59(6): 565-70. (Japanese).

9) Zimmermann M et al. Cellular origin and diagnostic significanceof high-fluorescent cells in cerebrospinal fluid detected by the XE-5000 hematology analyzer. International Journal of LaboratoryHematology. 2013; 35(6): 580-588.

10) Inoue H. Overview of Automated Hematology Analyzer XE-2100.Sysmex Journal International. 1999; 9(1): 58-64.

11) Hayashi M. How the IT Revolution is affecting trends in ClinicalTesting. Sysmex Journal International. 2000; 10(1): 1-2.

12) Briggs C et al. Evaluation of immature granulocyte counts by theXE-IG master: upgraded software for the XE-2100 automatedhematology analyzer. Lab. Hematol. 2003; 9(3): 117-24.

13) Yamaoka G et al. The immature platelet fraction is a useful markerfor predicting the timing of platelet recovery in patients withcancer after chemotherapy and hematopoietic stem celltransplantation. Int J Lab Hematol. 2010; 32(6 Pt 1): 208-16.

14) Sakuragi M et al. Clinical significance of IPF% or RP%measurement in distinguishing primary immune thrombocytopeniafrom aplastic thrombocytopenic disorders. Int J Lab Hematol.2015; 101(4): 369-75.


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introduction of products · 1) name: automated hematology analyzer xn-l series 2) model: xn-550...

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