Product Fact Sheet Added values XN CBC and XN DIFF · Sysmex Europe GmbH Bornbarch 1, 22848...

Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations.

Last updated on 10/08/2015 by Melanie Steffens - / 3

Product Fact Sheet Added values XN-CBC and XN-DIFF

Product name

Added value XN-CBC

Added value XN-DIFF

Manufacturer information

Sysmex Corporation

www.sysmex-europe.com

Summary

XN-Series offers a high analytical level of screening by fluorescence flow cytometry for the counting/differentiation of white blood cells in CBC and DIFF mode. The advanced XN-CBC profile includes the counting of rare event cells as basophils and nucleated red blood cells in every measurement. It reports NRBC as low as 0.1/100 WBC. Furthermore, interferences from non-cellular particles such as lyse-resistant RBC or lipids are avoided.The XN instrument always reports automatically corrected WBC values if NRBC are present. The differential of the XN-Series includes the counting of immature granulocytes (IG) and provides high sensitivity detection of WBC abnormalities. Samples showing a low white blood cell concentration can be re-measured automatically in the special “low WBC mode”. This ensures obtaining reliable results of all parameters including the differential by an extended count sequence. An additional dedicated pre-diluted mode is designed for the analysis of capillary samples as only 20 μL of blood is required.

Productivity values

Decreased turn-around time (TAT) as no reflex testing for NRBC is needed in all profiles

Reducing smears and potential manual errors by eliminating manual NRBC counts and by an improved flagging efficiency for WBC

Always correct WBC values in neonate samples by auto-correction for NRBC

Clinical values

Reliable NRBC counts for all neonate and adult samples of low and high counting ranges enable immediate therapeutic action, e.g. for patients in ICU

Highly sensitive detection of WBC abnormalities with improved flagging nomenclature guide to quick patient diagnosis

Support of detection of inflammations or infections and in therapy monitoring of infections

Specifications

Feature Description

Discrete mode CBC and CBC+DIFF

Sampling mode Whole blood mode

Low-WBC mode

Pre-dilution mode

Whole blood mode

Analysis time

36 s

Low-WBC mode

Analysis time

41 s

Pre-dilution mode

Analysis time

Dilution ratio

40 s

1:7

Technologies Fluorescence flow cytometry

Hydrodynamic focussed impedance measurement

Light emitting diode (LED) photometry

Adaptive cluster analysis system (ACAS) and special shape recognition analysis of each WBC subpopulation

Reflex testing optional available for

Myeloid and lymphatic information

Critical PLT information

Low-WBC mode

Diagnostic parameters

XN-CBC (16, incl. NRBC)

WBC – White blood cell count

NRBC%, NRBC# – Nucleated red blood cells

RBC – Red blood cell count

HGB – Haemoglobin

HCT – Haematocrit

MCV – Mean corpuscular volume

MCH – Mean corpuscular haemoglobin

MCHC – Mean corpuscular haemoglobin concentration

PLT – Platelet count (PLT-I)

http://www.sysmex-europe.com/

Product Fact Sheet Product Name or Title


Last updated on 10/08/2015 by Melanie Steffens- / 3

XN-DIFF (12)

RDW-SD – Red cell distribution width (standard deviation)

RDW-CV – Red cell distribution width (coefficient of variation)

PDW – Platelet distribution width

MPV – Mean platelet volume

P-LCR – Platelet large cell ratio

PCT – Plateletcrit

NEUT%, NEUT# – Neutrophils

LYMPH%, LYMPH# – Lymphocytes

MONO%, MONO# – Monocytes

EO%, EO# – Eosinophils

BASO%, BASO# – Basophils

IG%, IG# – Immature granulocytes

Research parameters

XN-CBC (6)

XN-DIFF (28)

Microcytic red blood cell ratio (MicroR)

Macrocytic red blood cell ratio (MacroR)

WBC-N

BA-N#, BA-N%

Total nucleated cell count WNR channel (TNC-N)

Total nucleated cell count DIFF channel (TNC-D)

WBC-D (TNC-D - NRBC#)

High fluorescence lymphocyte count (HFLC#, HFLC%)

NEUT#& (NEUT# - IG#)

NEUT%& (NEUT% - IG%)

LYMP#& (LYMPH# - HFLC#)

LYMP%& (LYMPH% - HFLC%)

Basophils analysed in the DIFF channel (BA-D#, BA-D%)

Neutrophil granulation (NE-SSC)

Neutrophil fluorescence (NE-SFL)

Neutrophil FW scatter (NE-FSC)

Lymphocyte SW scatter (LY-X)

Lymphocyte fluorescence (LY-Y)

Lymphocyte forward scatter (LY-Z)

Monocyte side scatter (MO-X)

Monocyte fluorescence (MO-Y)

Monocyte forward scatter (MO-Z)

Neutrophil side scatter width (NE-WX)

Neutrophil fluorescence width (NE-WY)

Neutrophil FW scatter width (NE-WZ)

Lymphocyte side scatter width (LY-WX)

Lymphocyte fluorescence width (LY-WY)

Lymphocyte FW scatter width (LY-WZ)

Monocyte side scatter width (MO-WX)

Monocyte fluorescence width (MO-WY)

Monocyte FW scatter width (MO-WZ)

Service parameters 29 (XN-CBC) and 16 (XN-DIFF)

Linearity (whole blood mode)

WBC

RBC

HGB

HCT

MCV

NRBC#

NRBC%

NEUT%

LYMPH%

MONO%

EO%

BASO%

IG%

Within ±3.0 % or ±0.20 x 103/μL (0.00 to

100.00 x 103/μL)

Within ±6.0 % (100.01 to 310.00 x 10

3/μL)

Within ±11.0 % (310.01 to 440.00 x 10

3/μL)

Within ±2.0 % or ±0.03 x 106/μL (0.00 to

8.00 x 106/μL)

Within ±4.0 % or ±0.06 x 106/μL (8.01 to

8.60 x 106/μL)

Within ±2.0 % or ±0.2 g/dL (0.0 to 25.0 g/dL, 0.00 to 15.52 mmol/L)

Within ±5.0 % or ±0.5 g/dL (25.1 to 26.0 g/dL, 15.53 to 16.14 mmol/L)

Within ±3.0 % or ±1.0 HCT (0.0 to 75.0 %)

Within ±3 % or ±2.0 fL

Within ±10.0 % or ±0.20 x 103/μL (0.00 to

20.00 x 103/μL)

Within ±20.0 % or ±2.0 NRBC % (0.0 to 600.0/100 WBC)

Within ±3.0 NEUT%

Within ±3.0 LYMPH%

Within ±2.0 MONO%

Within ±1.0 EO%

Within ±1.0 BASO%

Within ±1.5 IG%

Precision (whole blood mode)

WBC

RBC

HGB

HCT

MCV

MCH

MCHC

RDW-SD

RDW-CV

PDW

MPV

P-LCR

PCT

PLT

NRBC#

NRBC%

NEUT#

NEUT%

LYMPH#

LYMPH%

MONO#

MONO%

EO#

3.0 % or less (4.00 x 109/L or more)

1.5 % or less (4.00 x 1012

/L or more)

1.0 % or less

1.5 % or less

1.0 % or less

2.0 % or less

2.0 % or less

2.0 % or less

2.0 % or less

10.0 % or less

4.0 % or less

15.0 % or less

6.0 % or less

4.0 % or less (100 x 103/μL or more)

25.0 % or less, or within ±0.12 x 103/μL

25.0 % or less, or within ±1.5 NRBC% (WBC 4.00 x 10

3/μL or more)

8.0 % or less (1.20 x 103/μL or more)

8.0 % or less (30.0 NEUT% or more, WBC 4.00 x 10

3/μL or more)


8.0 % or less (15.0 LYMPH% or more, WBC 4.00 x 10

3/μL or more)


20.0 % or less (5.0 MONO% or more, WBC 4.00 x 10

3/μL or more)

25.0 % or less, or within ±0.12 x 103/μL



Last updated on 10/08/2015 by Melanie Steffens- / 3

EO%

BASO#

BASO%

IG#

IG%

25.0 % or less, or within ±1.5 EO% (WBC 4.00 x 10

3/μL or more)

40.0% or less, or within ±0.06 x 103/μL

40.0% or less, or within ±1.0 BASO% (WBC 4.00 x 10

3/μL or more)

25.0% or less or within ±0.12 x 103/μL

(IG# 0.10 x 103/μL or more)

25.0% or less or within ±1.5 IG% (IG% 2.0% or more, WBC 4.00 x 10

3/μL or

more)

Carry over (pre-dilution mode)

WBC

RBC

HGB

HCT

PLT

NRBC#

NEUT#

LYMPH#

MONO#

EO#

BASO#

1.0 % or less

1.0 % or less

1.0 % or less

1.0 % or less

1.0 % or less

2.0 % or 0.02 x 103/μL or less

2.0 % or 0.05 x 103/μL or less

2.0 % or 0.05 x 103/μL or less

2.0 % or 0.03 x 103/μL or less

2.0 % or 0.03 x 103/μL or less

2.0 % or 0.03 x 103/μL or less

Sample stability

8 hours

24 hours

36 hours

48 hours

72 hours

HCT within +5.0 %

MCV within +5.0 %

HCT within +8.0 % (in a refrigerator), within +15.0 % (stored at 18 to 26 °C)

MCV within +8.0 % (in a refrigerator), within +15.0 % (stored at 18 to 26 °C)

NRBC% within +10.0 % or ± 3.0/100 WBC

IG% within ±2.0 % IG%

NEUT% within ±8.0 NEUT%

LYMPH% within ±7.0 LYMPH%

MONO% within ±3.0 MONO%

EO% within ±3.0 EO%

BASO% within ±1.0 BASO%

PLT within +10% or ± 30 x 103/μL

NEUT% within ±8.0 NEUT%

LYMPH% within ±7.0 LYMPH%

MONO% within ±4.0 MONO%

EO% within ±3.0 EO%

BASO% within ±1.0 BASO%

WBC within ±10.0%

RBC within ±5.0%

HGB within ±5.0%

References: XN-Series IFU version February 2014


Last updated on 20/04/2017 by Michael Preukschas - Page 1 / 2

Product Fact Sheet Added value RET

Product name

Added value RET


Sysmex Corporation


Summary

Since anaemia is one of the most common symptoms of many diseases and one of the most underestimated RBC disorders, knowing the erythropoietic status is of prime importance for many patients. Next to the pure count of reticulocytes, the XN-Series ‘added value RET’ application provides the reticulocyte fractions (IRF, LFR, MFR, HFR) and additional information on the quality of the newly formed RBC by reporting the degree of the haemoglobinisation of the reticulocytes (RET-He) and red blood cells (RBC-He). The parameter Delta-He is derived from the difference between these two parameters. Delta-He values above the normal range may indicate an improvement in erythropoiesis, for example after EPO and/or iron therapy. In contrast, when Delta-He values are below the normal range for longer periods, this may indicate the onset of anaemia. In addition, the ‘added value RET’ application allows obtaining information about hypochromic and hyperchromic RBC, about microcytes and macrocytes as well as fragmentocytes and the automatic calculation of the reticulocyte production index (RPI).

Productivity values

• Quick screening of the erythropoietic status

Clinical values

• Reliable diagnosis of anaemic patients based on the complete picture of the erythropoiesis by qualitative and quantitative information

• Early prognosis of therapy monitoring by advanced clinical parameters and their combinations (e.g. RET-He, Delta-He, IRF)

Article number

Article no. Item Description Qty

ZE000322 Media Kit RET RET application kit 1

Specifications

Feature Description

Discrete mode (Depending on XN configuration)

CBC+RET

CBC+DIFF+RET

CBC+DIFF+WPC+RET

CBC+DIFF+RET+PLT-F

CBC+RET+PLT-F

CBC+DIFF+WPC+RET+PLT-F

Sampling mode Whole blood mode

Low-WBC mode

Pre-dilution mode


Diagnostic parameters 11*

RET% – Reticulocyte percent

RET# – Reticulocyte count

HFR – High fluorescence ratio

MFR – Medium fluorescence ratio

LFR – Low fluorescence ratio

IRF – Immature reticulocyte fraction

RET-He – Reticulocyte haemoglobin equivalent

RBC-He – Red blood cell haemoglobin equivalent

Delta-He – Difference between RET-He and RBC-He

HYPO-He – Percent hypochromic red blood cells

HYPER-He – Percent hyperchromic red blood cells

Research parameters (whole blood mode)

11*

RBC-O – Red blood cell count (optical)

RET-Y

RBC-X, RBC-Y

IRF-Y

FRC% – Fragmented red blood cell percent

FRC# – Fragmented red blood cell count



Last updated on 20/04/2017 by Michael Preukschas - Page 2 / 2

RPI – Reticulocyte production index

RET-UPP

RET-TNC

PLT-O

Service parameters 8

Linearity (whole blood mode)

RET%

RET#

IRF

LRF

MFR

HFR

PLT-O

Within ±20% or ±0.30 RET% (0.00 to 30.00%)

Within ±20% or ±0.0150 x 106/µL (0.0000 to 0.7200 x 106/µL)

Within ±30% or ±10.0 IRF%

Within ±30% or ±10.0 LFR%

Within ±30% or ±10.0 MFR%

Within ±30% or ±5.0 HFR%

Within ±7% or ±10 x 103/µL (0 to 5,000 x 103/µL)

Precision (whole blood mode)

RET%

RET#

IRF

LFR

MFR

HFR

RET-He

RBC-He

PLT-O

15.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%)

15.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%)

30.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%, IRF 20.0% or more)

30.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%, LFR 20.0% or more)

50.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00%, LFR 20.0% or more)

100.0% or less or within ±2.0 HFR% (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)

5.0% or less (RET# 0.02 x 106/µL or more)

5.0% or less

6.0% or less (100 x 103/µL or more)

Precision (pre-diluted mode)

RET%

RET#

PLT-O

35.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)

35.0% or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)

13.0 % or less (100 x 103/µL or more)

Sample stability (whole blood mode)

24 hours at RT and 4 °C

RET%

RET#

IRF

LFR

MFR

HFR

RET-He

RBC-He

± 20.0% or within ±0.3 RET%

± 20.0% or within ±0.015 x 106/µL

± 30.0 % or within ±10.0 IRF

± 30.0% or within ±10.0 LFR

± 30.0% or within ±10.0 MFR

± 30.0% or within ±5.0 HFR

Within ± 8.0% (RET# 0.0100 x 106/µL or more)

Within ± 8.0%

48 hours at RT and 4 °C

PLT-O

Within +15.0%

*Availability of certain diagnostic parameters depends on the IPU software version. Please refer to the release notes of IPU software 21.12 for further information.

References: XN-Series IFU version 1611 November 2016

RIAm: Regional IFU Amendment –Sysmex XN series October 2016

Product Fact Sheet Added value for the leucopoiesis


Last updated on 28/11/2016 by Telmo Costa - Page 1 / 2


Product name

Added value WPC


Sysmex Corporation www.sysmex-europe.com

Summary

High specificity in white precursor and pathological cells (WPC) analysis is provided with a dedicated measurement channel. It is dedicated for detecting malignant white blood cells with high specificity since they feature altered membrane characteristics. If the flags for ‘Blasts/Abn Lympho?’ or both ‘Atypical Lympho?’ and ‘Blasts/Abn Lympho?’ are triggered by the WDF channel, the automated WPC analysis can turn these into one of four more specific flagging messages: •‘Blasts?’ flag: indicates a suspected acute malignant disorder (e.g. acute leukaemias). •‘Abn Lympho?’ flag: points to a suspected malignant disorder of lymphocytes (e.g. chronic leukaemias and lymphomas). •‘Atypical Lympho?’ flag: points to a reactive disorder (e.g. infections or inflammations, allowing the characterisation of the state of the immune system. •‘Negative’: The high specificity of WPC analysis further filters out false-positive suspected malignant samples. The WPC analysis is triggered by a reflex testing after a positive detection in the CBC+DIFF mode. But for known special samples, e.g. from oncology wards, the profile may also be ordered initially. The WPC channel’s high specificity is contributing further to improve the laboratory workflow after the sensitive screening for WBC abnormalities in the CBC+DIFF profile. Especially laboratories handling a large number of samples with such abnormalities, e.g. from oncology or

haematology wards, will benefit from a significant smear reduction. False-positive and false-negative rates are both optimised and flagging algorithms effectively support the identification of myeloid and lymphatic malignancies.

The WPC channel further enables to use the optional XN Stem Cell mode. * * Only available after activation of ‘XN Stem Cells license’

Productivity values

Minimisation of the number of false-positive suspected malignant samples from the XN-DIFF, thus stream-lining the diagnostic pathway by reduction of follow-up tests

Confidence that the right smears are performed Decreased TAT time thanks to automatic reflex testing

Clinical values

Optimal differentiation between malignant and reactive samples and deeper insight into the immune response status once malignant conditions have been excluded

Assuring that the right smears are done and no time is invested in false positive samples

Faster follow-up of true pathological samples can become beneficial during the treatment process

Article number


ZE000324 Media Kit WPC WPC precursor kit 1

Specifications

Feature Description Discrete mode (depending on XN configuration)

CBC+DIFF+WPC CBC+DIFF+WPC+RET* CBC+DIFF+WPC+RET*+PLT-F* CBC+DIFF+WPC+PLT-F* *optional



Last updated on 28/11/2016 by Telmo Costa - Page 2 / 2

Sampling mode Whole blood mode ‘Low WBC’ mode Capillary/pre-diluted mode


Diagnostic parameters HPC% and HPC# Haematopoietic progenitor cell count only available after license activation (for more information refer to XN Stem Cells PFS)

Reflex testing Automatically triggered by the XN-DIFF flag ‘Blasts/Abn Lympho?’

Flagging information ‘Blasts?’ flag ‘Abn Lympho?’ flag ‘Atypical Lympho?’ flag Negative

Sample stability whole blood mode

24 hours at RT and at 4°C

References: XN-Series Instructions for Use Revised January 2016

Product Fact Sheet XN CHECK


Last updated on 05/01/2017 by Sandra Valdmanis - Page 1 / 2


Product name

XN CHECK

Manufacture information

Sysmex Corporation, Japan

"Producer" on OEM-Basis: STRECK, U.S.A.

Summary

The XN CHECK is a control blood designed to fit specifically to the XN-Series and XN-L Series instrumentation thus allowing to thoroughly checking the analysers’ technical functions and reagent system. The material enables an effective and reliable internal and external quality control of the XN-Series and XN-L Series haematology system.

Article number

Article no. Item Quantity

213487

213488

213489

213484

213485

213486

ZE000528

XN CHECK L1

XN CHECK L2

XN CHECK L3

XN CHECK L1

XN CHECK L2

XN CHECK L3

XN CHECK / XN CHECK BF USB stick (for XN-L Series)

1 x 3.0 mL

1 x 3.0 mL

1 x 3.0 mL

8 x 3.0 mL

8 x 3.0 mL

8 x 3.0 mL

1

Specifications

Feature Description

Concentration Available in three concentration levels named L1, L2 and L3 to cover the abnormal low, normal and abnormal high concentration range.

Parameter RBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, MicroR, MacroR

PLT(-I), PLT-F*, PDW, PCT, MPV, P-LCR, IPF (%,#)*

WBC, WBC-D, WBC-P*, NEUT (%,#), LYMPH (%/#), MONO (%/#), EO (%,#), BASO (%,#), NRBC* (%/#), IG (%/#), HPC (%,#)*, AS-LYMP (%,#)*

RET(%,#), HFR, MFR, LFR, IRF, RET-He, RBC-He, Hypo-He, Hyper-He, RBC-O, PLT-O

* not on XN-L Series

Composition Stabilised human red blood cells, human white blood cells, a platelet and nucleated red blood cell component in a preservative medium.

Application on XN-Series and XN-L Series

Measurement mode

Control mode

Temperature of use

Room temperature

Storage 2-8°C before and after opening

Period of use 8 weeks per lot

Open vial stability 7 days if stored at 2 - 8 °C.

Volume 3.0 mL per vial

Dead volume 1.0 mL per vial

IFU

(package insert)

The package inserts for XN CHECK are enclosed to the product as paper sheets in four languages only (English, French, Spanish, Portuguese).

They are available in 23 languages for download on www.sysmex-europe.com/ifu. The clam shell labels of both products reflect that situation by displaying this website for download of package inserts.

Assay data Provided as assay mean and assay

http://www.sysmex-europe.com/ifu

http://www.sysmex-europe.com/ifu



Last updated on 05/01/2017 by Sandra Valdmanis - Page 2 / 2

range.

Assay files Assay data is provided in electronic format for each lot and level of XN CHECK on

CD-ROMs (for XN-Series)

USB sticks (for XN-L Series & XN-Series).

Assay data input Upload of assay data from assay CD-ROM (XN-Series) and assay USB stick (XN-L Series & XN-Series).

Manual data input by manual typing.

Manual bar code data input (for XN-L Series): read in assay data via the barcode reader

External QC:

SNCS IQAS Online

Sysmex is offering the Sysmex Network Communication System (SNCS), which is an Internet based platform for online services. Part of SNCS is IQAS Online, which is based on the use of XN CHECK and XN CHECK BF and provides external quality control to continuously monitor the XN and XN-L Series performance range. That includes all diagnostic parameters as well as purely technical parameters (sensitivity parameters).

Product Fact Sheet XN-10


Last updated on 30/11/2015 by Melanie Steffens - Page 1 / 2


Product name

XN-10 with the standard Clinical Value applications


Sysmex Corporation


Summary

As the analysis module of the XN-solution portfolio, the XN-10 delivers an efficient processing of the sample analysis. Its technical performance provides reliable and accurate test results by applying a maximum of six measurement channels. The XN-10 can process primary sample tubes in sampler and manual mode via the same aspiration line. Further, micro tube samples and body fluid samples (with the optional XN-BF application) can be measured in the manual mode immediately.

Article numbers

Instruments


AP795756 XN-10 complete Analysis module 1

Reagents for dilution*


AJ370801 CELLPACK DST

Concentrated diluent (politainer) for preparation by RPU

20 L

BQ505775 CELLPACK DST


10 L

CT661628 CELLPACK DCL Diluent (politainer) 20 L

CU228496 CELLPACK DCL Diluent (politainer) 10 L

* Either CELLPACK DCL or CELLPACK DST is connected

Reagents for XN-CBC


90411414 SULFOLYSER Lysing reagent (politainer) to detect HGB

5 L

AN577063

Lysercell WNR

Surfactant (paper pack) to detect WBC and NRBC

2x4 L

BL121531 Surfactant (politainer) to detect WBC and NRBC

5 L

CP066715 Fluorocell WNR Labelling reagent (cartridge) to detect WBC and NRBC

2x 82 mL

Reagents for XN-DIFF


AW993605

Lysercell WDF

Surfactant (paper pack) to obtain the WBC differential

2x4 L

AL337564 Surfactant (politainer) to obtain the WBC differential

5L

CV377552 Fluorocell WDF Labelling reagent (cartridge) to obtain the WBC differential

2x

42 mL

Reagents for XN-RET


BT965910 CELLPACK DFL Surfactant (paper pack) to detect RET and PLT

2x 1.5 L

BN337547 Fluorocell RET Labelling reagent (cartridge) to detect RET and PLT-O

2x

12mL

Reagents for XN-PLT-F



2x 1.5 L

CD994563 Fluorocell PLT Labelling reagent (cartridge) to detect PLT-F

2x 12 mL




Last updated on 30/11/2015 by Melanie Steffens - Page 2 / 2

Quality control


213484 XN CHECK L1 Whole blood QC level 1 for XN

8 x 3 mL


8 x 3 mL


8 x 3 mL

213510 XN CHECK BF L1 and L2

Body fluid QC level 1 and 2 for XN

3 x 3 mL

213523 XN CAL Calibrator material

3 x 3 mL

Specifications

Feature Description

Number of diagnostic parameters*

Standard:

CBC+DIFF: 28

Optional:

RET: 7

PLT-F: 2

BF: 7

Number of research parameters*

Standard:

CBC+DIFF: 34

Optional:

RET: 15

PLT-F: 2

BF: 11

* For further details please refer to the Product Fact Sheets (PFS) on Added Values available on the Sysmex Extranet

Feature Description

Discrete mode profiles

Standard:

CBC (NRBC)

CBC (NRBC) + DIFF

Optionals (depending on the configuration):

CBC+RET

CBC+DIFF+RET

CBC+DIFF+RET+PLT-F

CBC+RET+PLT-F

CBC+PLT-F

CBC+DIFF+PLT-F

Body fluid

Sampling mode Standard:

Whole blood mode

Low WBC mode

Pre-dilution mode

Optional:

Body fluid mode

Aspiration volume

Sampler mode

Manual open mode

Manual closed mode

Pre-dilution mode

Micro analysis

Body fluid mode

88 µL

88 µL

88 µL

70 µL

88 µL (micro tube)

88 µL

Required sample volume

Whole blood mode:

Sampler mode

Manual closed

Manual open

Pre-dilution mode:

Manual open

Body fluid mode:

Manual closed

Manual open

1 mL

1 mL

300 µl (regular tube)

160 µl (micro tube)



1 mL



Operative temperature

15 °C to 30 °C

Operative humidity 30 % to 85 %

Power requirement AC 100 to 240 V (50/60 Hz)

Power consumption 270 VA or less

Reference: XN IFU EU 1105

Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated: 26/11/2015 - Page 1 / 2


Product name

XN-20 with the standard applications


Sysmex Corporation


Summary

As the analysis module of the XN–solution portfolio, the XN-20 provides reliable and accurate test results by applying a maximum of seven measurement channels, including one dedicated to white precursor cells (WPC). The XN-20 can process primary sample tubes in sampler and manual mode via the same aspiration line. Micro tube samples and body fluid samples (with the optional XN-BF application) can be measured in the manual mode immediately.

Article numbers


AE97961 XN-20 complete Analysis module 1

Reagents for dilution*


AJ370801 CELLPACK DST


20 L

BQ505775 CELLPACK DST


10 L

CT661628 CELLPACK DCL Diluent (politainer) 20 L

CU228496 CELLPACK DCL Diluent (politainer) 10 L

* Either CELLPACK DCL or CELLPACK DST is connected

Reagents for XN-CBC


90411414 SULFOLYSER Lysing reagent (politainer) to detect HGB

5 L

AN577063

Lysercell WNR

Surfactant (paper pack) to detect WBC and NRBC

2x 4 L

BL121531 Surfactant (politainer) to detect WBC and NRBC

5 L

CP066715 Fluorocell WNR Labelling reagent (cartridge) to detect WBC and NRBC

2x 82 mL

Reagents for XN-DIFF


AW993605

Lysercell WDF

Surfactant (paper pack) to obtain the WBC differential

2x 4 L

AL337564 Surfactant (politainer) to obtain the WBC differential

5 L

CV377552 Fluorocell WDF Labelling reagent (cartridge) to obtain the WBC differential

2x 42 mL

Reagents for XN-RET



2x 1.5 L

BN337547 Fluorocell RET Labelling reagent (cartridge) to detect RET and PLT-O

2x 12 mL

Reagents for XN-PLT-F



2x 1.5 L

CD994563 Fluorocell PLT Labelling reagent (cartridge) to detect PLT-F

2x 12 mL




Last updated on 26/11/2015 by Melanie Steffens- Page 2 / 2

Reagents for XN-WPC


CS412800 Lysercell WPC Surfactant (paper pack) to be used in the WPC channel

2x 1.5 L

BU306227 Fluorocell WPC

Labelling reagent (cartridge) to be used in the WPC channel

2x 12 mL

Quality control



8 x 3 mL


8 x 3 mL


8 x 3 mL

213510 XN CHECK BF L1 and L2

Body fluid QC level 1 and 2 for XN

3 x 3 mL

213523 XN CAL Calibrator material

3 x 3 mL

Specifications

Feature Description

Number of diagnostic parameters*

Standard:

CBC+DIFF: 28

Optional:

RET: 7

PLT-F: 2

BF: 7

Research parameters

Standard:

CBC+DIFF: 34

Optional:

RET: 15

PLT-F: 2

BF: 11

* For further details please refer to the Product Fact Sheets (PFS) on Added Values available on the Sysmex Extranet

Feature Description


Standard:

CBC (NRBC)

CBC (NRBC)+DIFF

CBC+RET

CBC+DIFF+RET

CBC+DIFF+RET+WPC

Optionals (depending on the configuration):

CBC+RET+PLT-F

CBC+DIFF+RET+PLT-F

CBC+DIFF+RET+PLT-F+WPC

CBC+PLT-F

CBC+DIFF+PLT-F

Body fluid

Sampling mode Standard:

Whole blood mode

Low WBC mode

Pre-dilution (PD) mode

Optional:

Body fluid mode

Aspiration volume

Sampler mode

Manual closed

Manual open

Pre-dilution mode

Micro analysis

Body fluid mode

88 µL

88 µL

88 µL

70 µL

88 µL (micro tube)

88 µL

Required sample volume

Whole blood mode:

Sampler mode

Manual closed

Manual open

Pre-dilution mode:

Manual open

Body fluid mode:

Manual closed

Manual open

1 mL

1 mL





1 mL




15 °C to 30 °C

Operative humidity 30 % to 85 %


Power consumption 270 VA or less

Reference: XN IFU EU 1105


Sysmex Europe GmbH Sysmex Europe GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone +49 40 52726-0 Fax +49 40 52726-100 [email protected] www.sysmex-europe.com Design and specifications may be subject to change without notice due to further product development and it is not intended to grant rights or impose obligations. Last updated on 07/01/2015 by Claudia Dahmen - Page 1 / 3

Product Fact Sheet XN-1000 Pure

Product name

XN-1000 Pure


Sysmex Corporation


Summary

The XN-1000 Pure provides the full flexibility of profiles in haematology testing. It targets at laboratories with small to medium workloads where 100 samples/h are suitable. The measurement of routine haematology profiles includes already advanced clinical parameters like nucleated red blood cells (NRBC) and immature granulocytes (IG). Equipped with an additional application for reticulocyte measurement, the XN RET APP, reticulocyte haemoglobin equivalent gives a complete picture and early prognosis of the patient’s erythropoesis by quality and quantity information.

The new XN-IPU (Information Processing Unit) eases operations, fully monitors the analyser performance 24/7 through continuous remote service and supports the accreditation of labs by ensuring i.e. full reagent traceability.

Productivity values

The first step into full automation: excellent productivity per square metre

Decreased TAT through potential reduction of smears by diagnostic applications

Clinical values

Standard routine testing supports detection of inflammations or infections and therapy monitoring of infections by reliably counted nucleated red blood cells (NRBC) and immature granulocytes (IG)

Using the optional RET application reliable diagnosis of anaemic patients based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard and early prognosis of therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET-He, IRF)

Availabilty of results of high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count

completed by PMN, MN) by using the optional BF mode

Configurations

No.

Name Application Description

1

XN-1000 [DIFF]

1 XN-10 unit with a non-reflex sampler for CBC+DIFF screening

Optional BF mode

2

XN-1000 [RET]

XN-10 unit with a non-reflex sampler for CBC+DIFF screening + RET




Optional BF mode

Main components


AP795756 XN-10 haematology unit

Unit for haematology screening testing for the configuration 1,2

1

CM660381 Non-reflex sampler for XN-1000

Sampler main unit to be connected with XN-10

1

AL898214 XN-1000 supply parts (SA-01)

IFU, cables, tubes etc. 1

01330061 Pneumatic unit

External pneumatic unit for XN instruments

1

3700037 Monitor arm Monitor arm to connect the IPU touch screen

1

37000088 XN IPU Instrument processing unit to operate the analyser

1

37000033 XN touch panel

Touch screen for XN IPU

1

Specifications

Feature Description

Diagnostics parameters (whole blood)

Up to 36 depending on the configuration (refer to “PFS_XN-10”)

Research parameters (whole blood)

Up to 42 depending on the configuration (refer to “PFS_XN-10”)

Diagnostics parameters (BF)

Up to 7 depending on the configuration (refer to “PFS_XN added value BF”)

Research parameters (BF)

Up to 11 depending on the configuration (refer to “PFS_XN added value BF”)

Scattergram & histogram

Up to 15 scattergrams

Up to 4 histograms


(refer to “PFS_XN-10”)


Hydrodynamic focussed impedance measurement

Light emitting diode (LED) photometry

Adaptive cluster analysis system (ACAS) and special shape

recognition analysis of each WBC subpopulation

Throughput

CBC

CBC+DIFF

CBC+DIFF+RET

CBC+RET

Body Fluid analysis

Up to 100 samples/hour




Up to 40 samples/hour (BF modus only)

Sampler unit loading capacity

5 racks (50 samples)

STAT function Approx. 1 min by using the manual mode

Reagent management

Always available

Data storage

Analysis registration function

Samples (incl. graphics)

Patient information

Wards registered

Doctors names registered

Selective test orders

Quality control files

Reagent replacement history

Maintenance history

2,000 records

100,000 results (including histograms and scattergrams)

10,000 records

200 wards

2,000 records

12 discrete profiles (depending on the configuration)

99 files 300 plots x 94 files (L-J control)

300 plots x 5 files (XbarM control)

5,000 records

5,000 records



Dimension

Main unit (incl. sampler unit)

Pneumatic unit

520x 840x 680 mm (WxHxD)

280x400x355 mm (WxHxD)

Weight

Main unit (incl. sampler unit)

Pneumatic unit

Approx. 70 kg

Approx. 17 kg

QC functions

Xbar and or L-J

Xbar M

300 plots x 94 files (L-J control)


Interface LP, DP, GP, host computer via LAN


15 to 30 °C

Operative humidity

30 to 85 %

Power requirement

Main unit

Sampler

Pneumatic unit

AC 100 to 240 V (50/60 Hz)

AC 100 to 240 V +/-10 %

AC 220 to 240 V (50/60 Hz)

Power consumption

Main unit

Sampler

Pneumatic unit

270 VA or less

110 VA or less

50 Hz: 230 VA or less (100-117 V), 220 VA or less (220-240 V) 60 Hz: 280 VA or less (100-117 V), 250 VA or less (220-240 V)

Reference: XN-1000 IFU 1302


Last updated on 02/12/2016 by SVCMOSS - Page 1 / 3


Product name

XN-350


Sysmex Corporation


Summary

The XN-350 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design®, high levels of performance and operability and proven Sysmex technology, the XN-350 provides full flexibility of profiles in haematology testing.

Optional productivity values

Reliable analysis and accurate WBC counts including differentials for leucocytopenic samples in L-WBC measurement mode.

Decreased TAT by using the Speed-up application

due to increased throughput from 60 to 70 samples/hour.

Standard clinical values

Standard routine CBC and DIFF testing delivers a great range of clinically relevant parameters. The DIFF testing supports the detection of infections and provides guidance for diagnosis and therapy monitoring of infections by reliably counting immature granulocytes (IG).

Optional clinical values

Using the optional RET application, reliable diagnosis of anaemic patients, based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard. Early prognosis for therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET-He, IRF). In addition, the RET application provides improved PLT count reliability due to an automated switching algorithm in the case of interferences such as RBC fragments, microcytic RBC or giant PLT etc.

Using the optional BF application, availability of results

with high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode becomes standard.

Main components

BOM Item Description Qty

SE000620 XN-350 XN-350 main unit including items listed in the table below

1

The following items are included in the BOM:

Article No. Item Description Qty

AW618382 XN-350 XN-350 main unit (excl.supply parts)

1

38000340 Handheld BR Gryphon

Handheld barcode reader (excl. cable for

1





connection to instrument)

38000313 CAB-426 CABLE XN/XT/XS/UF-1000I

Cable for connection of handheld barcode reader to instrument

1

CE537607 XN-350/450 SUPPLY PARTS (EU)

Supply parts (for detailed content see IFU)

1

ZE000539 Perixx Keyboard PERIBOARD-505H PLUS [US]

Additional keyboard for service (international keyboard)

1

ZE000671

XN-L PRBC FLAG LICENCE

XN-L licence to activate the iRBC? Flag, which is mandatory on each XN-L analyser

1

ZE000544 XN-L INSTALLATION KIT

Installation kit (incl. ZE000537 XN-L EMBEDDED SOFTWARE-IPU MEDIAKIT, ZE000538 XN-L Labelling KIT)

1

Optional components


ZE000540 XN-L BF licence XN-L licence for the BF mode

1

ZE000541 XN-L RET licence

XN-L licence for the RET channel

1

ZE000542 XN-L L-WBC licence

XN-L licence for the low WBC mode

1

ZE000543 XN-L Speed-up licence

XN-L licence for higher throughput

1

ZE000583 AGED SAMPLE IDENTIFIER

XN-L software ASI Package, includes: ASI certificate, 3 APP stickers and a fixing template to place the stickers properly on the analyser

1

01330061 PU-17 COMPLETE 200V(white)

Additional pneumatic unit for use at high altitude

1

ZE000321 Extended IPU Media kit

SW to interlink all Sysmex workplaces to improve sample and data workflow

1

VS933AV Extended IPU server hardware Standard

Computer hardware for the Extended IPU server

1

XL510AV Extended IPU Computer hardware 1

client hardware for an Extended IPU client

XN375ATABB

Extended IPU TFT monitor

TFT monitor for Extended IPU server and client hardware

1

SE000893 Ext. IPU SQLSV

2012 STD RT 1 LIC 5 CAL

SQL Server Licence for Extended IPU; CAL licence package including licences for 5 CALs

1

ZE000902 Handheld BR GRYPHON Cordless complete

Handheld cordless barcode reader as alternative for 38000340

1

38000305 Gryphon Desk-/Wall Holder

Wall holder for handheld barcode reader 38000340

1

AK369883 Intake Tube ASSY NO. 12

For connecting 20 L CELLPACK DCL (politainer)

1

ZE000550 Spout Kit FOR 5L POLITAINER

For connecting 5 L Sulfolyser (politainer) and 5L Lysercell WDF (politainer)

1

CM915147 Intake Tube ASSY NO. 70

For connecting 4 L Lysercell WDF (paper pack) and 1.5 L CELLPACK DFL (paper pack)

1

Reagents

Article no. Item Qty

CU228496 CELLPACK DCL 10 L

05433514 SULFOLYSER 1 x 500 mL


BG689680 LYSERCELL WDF 1 x 2 L

AA325279 FLUOROCELL WDF 2 x 22 mL

83401621 CELLCLEAN 1 x 50 mL

CF579595 CELLCLEAN AUTO 20 x 4 mL

AR829995 CELLPACK DFL 1 x 1 L

CU920210 FLUOROCELL RET 2 x 12 mL

Quality control and calibration


213570 XN-L CHECK L1 6 x 3 mL






213484 XN Check L1 8 x 3 mL



213510 XN Check BF 2 levels

3 x 3 mL

213523 XN CAL 3 x 3 mL

ZE000600 USB STICK XN-L CHECK 1

ZE000528

USB STICK

XN Check/XN Check BF

1

ZE000548 USB STICK XN CAL 1

Specifications

Feature Description

Standard parameters 28 Standard diagnostic parameters

WBC, RBC, HGB, HCT, MCHC, MCH, MCV, PLT, RDW-SD, RDW-CV, MPV, PDW, P-LCR, PCT, MicroR, MacroR

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

Optional parameters

18 Optional diagnostic parameters

RET%, RET#, IRF, LFR, MFR, HFR, RET-He, Delta-He, RBC-He, HYPO-He, and HYPER-He

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

Research parameters 31 Research parameters

TNC, TNC-C, TNC-D, WBC-C, WBC-D, NE-SSC, NE-SFL, NE-FSC, NRBC #, NRBC %, HFLC#, HFLC%

FRC#, FRC%, RPI, RBC-O, HGB-O, MCHC-O, Delta-HGB,

PLT-O

HF-BF#, HF-BF%, NE-BF#, NE-BF%, LY-BF#, LY-BF%, MO-BF#, MO-BF%, EO-BF#, EO-BF%, RBC-BF-2


Hydrodynamic focused

impedance measurement

SLS Haemoglobin method

Throughput

CBC

CBC+DIFF

CBC+RET

CBC+DIFF+RET

Body Fluid (BF) analysis

Up to 60 (70*1) samples/hour




Up to 30 samples/hour (BF mode only) 1 – With optional Speed-up Licence

Aspiration volume

Manual mode

Low WBC mode

Pre-dilution mode

Body fluid mode

25 µL

25 µL

70 µL

70 µL

Data storage


Patient information

Wards registered


Calibration log




Maintenance history

100,000 (including histograms and scattergrams)

10,000

200 wards

200 names

20 records

99 files (300 plots per file)

2,000 records

5,000 records

5,000 records

QC functions

Xbar and or L-J

XbarM



Weight Approx. 35 kg

Dimensions Approx. 450 (W) x Approx. 460 (D) x Approx. 510 (H) mm

Interface RS-232C, 2x Ethernet (RJ45), 4x USB

Operating system Embedded Microsoft ® Windows 7 with McAfee Security

Operative temperature 15 to 35 °C

Operative humidity 20 to 85 %

Noise level 60dB or less


Power consumption 235 VA

Reference: XN-L BO, GI & TS IFU 1606




Product name

XN-450


Sysmex Corporation


Summary

The XN-450 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design®, high levels of performance and operability and proven Sysmex technology, the XN-450 provides full flexibility of profiles in haematology testing.











Main components

BOM No. Item Description Qty


1


Article No. Item Description Qty

BM392756

XN-450 XN-450 main unit (excl. supply parts)

1


Handheld barcode reader (excl. cable for

1





connection to instrument)



1

CE537607 XN-350/450 SUPPLY PARTS (EU)


1



1

ZE000671



1



1

Optional Components


ZE000540 XN-L BF licence XN-L licence for the BF mode

1



1



1

ZE000543 XN-L Speed-up licence

XN-L licence for higher throughput

1



1

01330061 PU-17 COMPLETE 200V(white)


1

ZE000321 Extended IPU Media kit


1

VS933AV Extended IPU server hardware Standard


1

XL510AV Extended IPU Computer hardware 1

client hardware for an Extended IPU client

XN375ATABB

Extended IPU TFT monitor

TFT monitor for Extended IPU server and client hardware

1

SE000893 Ext. IPU SQLSV

2012 STD RT 1 LIC 5 CAL

SQL Server Licence for Extended IPU; CAL licence package including licences for 5 CALs

1

ZE000902 Handheld BR GRYPHON Cordless complete


1



1



1


For connecting 5 L Sulfolyser (politainer) and 5 L Lysercell WDF (politainer)

1



1

Reagents























3 x 3 mL

213523 XN CAL 3 x 3 mL


ZE000528

USB STICK


1


Specifications

Feature Description

Standard parameters (whole blood)

28 Standard diagnostic parameters



Optional parameters







PLT-O



Hydrodynamic focused

impedance measurement


Throughput

CBC

CBC+DIFF

CBC+RET

CBC+DIFF+RET







Aspiration volume

Manual mode

Low WBC mode

Pre-dilution mode

Body fluid mode

25 µL

25 µL

70 µL

70 µL

Data storage


Patient information

Wards registered


Calibration log




Maintenance history


10,000

200 wards

200 names

20 records


2,000 records

5,000 records

5,000 records

QC functions

Xbar and or L-J

XbarM



Weight Approx. 35 kg

Dimensions Approx. 450 (W) x Approx. 460 (D) x Approx. 440 (H) mm







Power consumption 235 VA





Product name

XN-550


Sysmex Corporation


Summary

The XN-550 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design®, high levels of performance and operability and proven Sysmex technology, the XN-550 provides full flexibility of profiles in haematology testing. Additionally, the built-in Rerun & Reflex and Intelligent Rack Sampling functionalities provide a more streamlined workflow and a decrease in the sample turnaround time.

Standard productivity values

Superb performance and decreased TAT through an integrated IPU rule set for automated Rerun and Reflex testing

Decreased TAT through automatic measurement of

raised bottom tubes (RBT) by Intelligent Rack Sampling.















Main components

BOM No. Item Description Qty


1



BD634545

XN-550 XN-550 main unit with 2 sampler adapter with the capacity of 10 samples each. (excl. supply parts)

1


Handheld barcode reader (excl. cable for connection to instrument)

1



1

AH172969

XN-550 SUPPLY PARTS (EU)


1



1

ZE000671



1



1

Optional Components


ZE000540 XN-L BF licence

XN-L licence for the BF mode

1



1



1

ZE000543 XN-L Speed-up XN-L licence for 1

licence higher throughput



1

01330061

PU-17 COMPLETE 200V(white)


1

ZE000321 Media kit Extended IPU


1

VS933AV Extended IPU server hardware


1

XL510AV Extended IPU

client hardware

Computer hardware for an Extended IPU client

1

XN375ATABB Extended IPU

TFT monitor

TFT monitor for Extended IPU server

and client hardware

1

SE000893

Ext. IPU SQLSV 2012 STD RT 1 LIC 5 CAL

SQL Server Licence for Extended IPU;

CAL licence package including licences for 5 CALs

1

ZE000902

Handheld BR GRYPHON Cordless complete


1



1



1


For connecting 5 L Sulfolyser (politainer) and 5 L Lysercell WDF (politainer)

1



1

Reagents























3 x 3 mL

213523 XN CAL 3 x 3 mL


ZE000528

USB STICK


1


Specifications

Feature Description

Standard parameters (whole blood)

28 Standard diagnostic parameters



Optional parameters







PLT-O



Hydrodynamic focused impedance measurement


Throughput

CBC

CBC+DIFF

CBC+RET

CBC+DIFF+RET







Aspiration volume

Manual mode

Sampler mode

Low WBC mode

Pre-dilution mode

Body fluid mode

25 µL

25 µL

25 µL

70 µL

70 µL

Data storage


Patient information

Wards registered


Calibration log




Maintenance history


10,000

200 wards

200 names

20 records


2,000 records

5,000 records

5,000 records

QC functions

Xbar and or L-J





XbarM 300 plots x 3 files (XbarM control)

Weight

Main unit (incl. SU*)

Monitor

Approx. 53 kg

Approx. 3 kg

Dimensions

Main unit

Monitor

Approx. 450 (W) x Approx. 660 (D) x Approx. 450 (H) mm

Approx. 267 (W) x Approx. 205 (D) x Approx. 240 (H) mm






Power requirement

Main unit

AC 100 to 240 V (50/60 Hz)

Power consumption

250 VA



Product Fact Sheet Added value for the body fluid analysis

Product name

Added value XN-BF


Sysmex Corporation


Summary

The automated body fluid mode is dedicated to the analysis of CSF (cerebrospinal fluid), synovial, pleural, CAPD or ascites fluids.

A special prolonged counting sequence provides a precise count of nucleated cells also in lowest counting ranges such as applicable for CSF.

Productivity values

• Standardisation and reproducibility

• Reduction of manual chamber counts

• Reduction of cytospin smear preparation and analysis

• Convenient automatic measurement of a variety of body fluids without sample pre-treatment

• Fast analysis 24 hours per day, 7 days a week

Clinical values

• Results of high precision in clinically relevant concentration ranges

• Support in detection of inflammatory processes (e.g. by WBC-BF count completed by PMN, MN)

Article number


ZE000325 Media Kit BF Body fluid application kit 1

Specifications

Feature Description

Discrete mode Body fluid mode

Sampling mode Manual mode (open or closed)


Diagnostic parameters 7

WBC-BF = White blood cell count (BF)

RBC-BF = Red blood cell count (BF)

TC-BF = Total cell count (BF)

MN# = Mononuclear cell count

PMN# = Polymorphonuclear cell count

MN% = Mononuclear cell percent

PMN% = Polymorphonuclear cell percent

Research parameters 11

HF-BF# = High fluorescence cell count (BF)

HF-BF% = High fluorescence cell percent (BF)

LY-BF# = Lymphocyte count (BF)

LY-BF% = Lymphocyte percent (BF)

MO-BF# = Monocyte count (BF)

MO-BF% = Monocyte percent (BF)

NEUT-BF# = Neutrophil count (BF)

NEUT-BF% = Neutrophil percent (BF)

EO-BF# = Eosinophil count (BF)

EO-BF% = Eosinophil percent (BF)

RBC-BF2 = Red blood cell count (BF) 2

Service parameters 4

Linearity (body fluid mode)

WBC-BF

RBC-BF

TC-BF#

Within ±0.010 x 103/µL (0.000 to 0.050 x

103/µL)

Within ±20.0% (0.051 to 10.000 x 103/µL,

RBC < 1.00 x 106/µL)

Within ±3.0% or within ±0.030 x 106/µL

(0.000 to 5.000 x 106/µL)

Within ±0.010 x 103/µL (0.000 to 0.050 x

103/µL)

Product Fact Sheet Added value for the body fluid analysis


WBC-BF

RBC-BF

TC-BF#

MN#

PMN#

MN%

PMN%

Within ±20.0% (0.050 to 10.000 x 103/µL,

RBC < 1.00 x 106/µL)

r=0.9 or more, and within slope=1 ±0.3



r = 0.9 or more, and within slope=1 ±0.5




Precision (body fluid mode)

WBC-BF

RBC-BF

TC-BF#

30.0% or less (0.005 to 0.015 x 103/µL)

15.0% or less (0.016 to 0.030 x 103/µL)

10.0% or less (0.031 to 0.050 x 103/µL)

40% or Max - Min ≤ 0.007 x 106/µL

(0.003 to 0.050 x 106/µL)

30.0% or less (0.005 to 0.015 x 103/µL)

15.0% or less (0.016 to 0.030 x 103/µL)

10.0% or less (0.031 to 0.050 x 103/µL)

Carry over (body fluid mode)

WBC-BF

RBC-BF

TC-BF#

0.3 % or 0.001 x 103/µL or less

0.3 % or 0.003 x 103/µL or less

0.3 % or 0.001 x 103/µL or less

Aspirated sample volume

88 µL

Required sample volume (micro tube)

160 µL

References: XN-series IFU version May 2011

Product Fact Sheet Added values XN CBC and XN DIFF · Sysmex Europe GmbH Bornbarch 1, 22848...

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Transcript of Product Fact Sheet Added values XN CBC and XN DIFF · Sysmex Europe GmbH Bornbarch 1, 22848...