Xt 2000i cell counter Autoanalyser

SYSMEX SINGAPORE PTE LTD

XT-2000iXT-2000i

SYSMEX SINGAPORE PTE LTD XT-2000i Launch

Actual Trends in HealthcareActual Trends in Healthcare

. Increase in elderly population

.Total reform of medical/hospital system

.Overall reduction of public spending

.Reduction of public healthcare costs

.Outcome related medicine

. Information instead of data required

.Software solutions demanded


Hospital structure JapanHospital structure Japan

Long-term careHospital

UniversityHospital

Basic care Hospital


Common Structure in AsiaCommon Structure in Asia

H e a lthC lin ic

H e a lthC lin ic

H e a lthC lin ic

D is tric tH o sp ita l

H e a lthC lin ic

H e a lthC lin ic

H e a lthC lin ic


H e a lthC lin ic

H e a lthC lin ic

H e a lthC lin ic


G e n e ra lH o sp ita l


Core-Lab

SatelliteLab.

Sender/Ward

Sender/Ward

SatelliteLab.

Sender/Ward

Sender/Ward

SatelliteLab.

Sender/Ward

Hospital/Commercial Lab structure Hospital/Commercial Lab structure


XT-2000i Development PhilosophyXT-2000i Development Philosophy

.Reduction of healthcare expenses

. Improve lab productivity and hospital cost efficiency

.Support Disease management (outcome related medicine)

.Adapt to new hospital/commercial lab structures

XT-2000XT-2000ii

ConceptConcept


Main CharacteristicsMain Characteristics

. Taking over the technology established by XE-2100.

. unifying the results, reagents, and operation with XE.

. User friendly, easy to use data management

. Additional parameters (clinical information)

. Discrete analysis

. 48 hr sample stability

. Provides additional features:

. Network function

. Windows 2000

. SNCS (on line QC and remote maintenance: under development)

. Full-auto Ret analysis


Main CharacteristicsMain Characteristics

. Suggests a solution of:

. XE-2100 for core lab

. XT-2000i for satellite lab

. To maintain high reputation and market price for XE and XT-2000i

. Introduction of XT-1800i


XE family conceptXE family concept

. Breeding the analyzer.

.XE developments are continued.

.new algorithm

.new functions

. When new feature or technology is adopted to XE-2100, also XT will get this

.vice versa

.except the technical limitation.

.i.e. NRBC for XT.


Year

Valu

e

Ver. UP

Ver. UP

XE-2100

XE-2100L

XT-2000i

XT-1800i

XE-2100

XE-2100L

XT-2000i

XT-1800i

XE-2100

XE-2100L

XT-2000i

XT-1800i

Progress of XE FamilyProgress of XE Family


Core and Satellite Lab.Core and Satellite Lab.

Sysmex

XE-2100

Sysmex

XE-2100

Core Lab

SysmexXT-2000i

Satellite Lab B

Same ReagentsSame Results

Same Operation

HSTAlpha

SysmexXT-2000i

Satellite Lab C

SysmexXT-2000i

Satellite Lab A


Inherit XE technologiesInherit XE technologies

. Analysis principle

. FCM (Semiconductor Laser)

. Reagent System

. Network function

.TCP/IP connection

. Research Parameter

. IG

. Research Screen

. Q-Flag system

. SNCS:

.online QC/remote maintenance


PhilosophyPhilosophy

.Provide clinically relevant information of high accuracy to doctors

.Resting cost reduction in compliance with governmental regulations

.Top-level network system: internal and external

.Shorten TAT


XT-SeriesXT-Series

Model Parameter

XT-2000i CBC+DIFF+RET

XT-1800i CBC+DIFF

Two types of XT series


Schedule Schedule

XT-2000i XT-1800i

Release Date

EU and AP: February, 2002

EU and AP: May, 2002

US: June, 2002 *after FDA approval

US: July, 2002 *after FDA approval

Japan: April, 2002

Japan: May, 2002


Running cost comparison XT vs. SFRunning cost comparison XT vs. SF

. Theoretical Calculation

.XT > SF-3000

. Actual simulation

.XT < SF-3000

.Discrete testing: cost effective

.Less maintenance: cost effective

.Fully automated RET analysis (XT-2000i)

XT-2000iXT-2000i

SpecificationsSpecifications


XT-2000i ParametersXT-2000i Parameters

.33 ParametersWBC, RBC, HGB, Hct, MCV, MCH, MCHC, PLTRDW-CV, RDW-SD, MPV, PDW, P-LCR, PCT,NEUT %, LYMPH %, MONO %, EO %, BASO %, IG %, NEUT #, LYMPH #, MONO #, EO #, BASO #, IG #‚ RET %, RET #, LFR, MFR, HFR, IRF, PLT-fl

.2 HistogramsRBC, PLT

.5 ScattergramsDIFF, WBC/BASO, RET, PLT-O, RET-EXT


Sample VolumeSample Volume

.Capillary Blood 40 µl

.Open Mode 85 µl

.Manual Closed 150 µl

.Automode 150 µl


ThroughputThroughput

.CBC 80 samples/h

.CBC + Diff 80 samples/h

.CBC + Diff + RET 80 samples/h

.CBC + RET 80 samples/h


AutomationAutomation

.Samples for 50 samples (5 rack 10 tubes)

.Barcode reader for positive patient identification

.Continuous sample loading

.Comprehensive Information Processing System

.Minimised maintenance

.Selectivity

.Closed mode sampling


Information Processing System (IPU)Information Processing System (IPU)

.Storage 10.000 patient results inclusive all scattergrams and histograms

.Work list 1000 samples

.Auto validation

. Interpretive messages

.Quality Control


Reagent SystemReagent System

NameAbbreviation

Cellpack EBKSulfolyser SLSStromatolyser 4DS FFSStromatolyser FB FBAStromatolyser 4DL FFDRet Search 2 Dye REDRet Search 2 Lyse RED


Order information• CBC• CBC + DIFF• CBC + DIFF + RET• CBC + RET

Selectivity of XT-2000iSelectivity of XT-2000i

Barcode readingof each sample

Selective Analyse after ordering

Central-PCWork listBarcode

Results

Configurations XT-2000iConfigurations XT-2000i


OptionsOptions

. PIM software

. TCM software: two unit connection with 1 x IPU** only for the same model type available.

. Twin of “XT-2000i and XT-1800i” or “XE-2100 and XT-2000” is not possible.

. Sampler (50samples)

. Bar coder reader (sampler)

. Handheld barcode reader local supply

. Printer (GP/LP) local supply

. Ticket printer (DP-510)

•

XT Twin


XT-2000i Twin ConfigurationXT-2000i Twin Configuration

Two XT-2000i systems, one Information Processing System (IPU)

160 Samples per hour Every 23 seconds a CBC + differential result


Configuration ImageConfiguration Image

Main UnitXT IPU

Pneumatic unit

TCP/IP connection

Sampler

accessory

PIM

TCM

BCR

O/M Basic soft

XT-seriesXT-series

Analysis PrincipleAnalysis Principle


AnalysisBlock

Principle

Analysischannel

Information

RBC/PLT WBC

Hydrodynamic Focusing - DC Detection -

Flow cytometry

RBC/PLTchannel

PLThistogram

Parameter PLT HGB

HGBchannel

ColorimetricDetermination

HGB

Whole blood sample

DIFFchannel

RETchannel

DIFF

scattergram

WBC#Baso

RETPLT-OIRF

RETscattergram

LymphMonoNeut+BaEO*IG - research

RET

Flow cytometry

WBC/Bachannel

WBCscattergramRBC

histogram

RBC

XT-2000i Multi Channel AnalyserXT-2000i Multi Channel Analyser


XT-2000i Multi Channel AnalyserXT-2000i Multi Channel Analyser

Channel Principle / Dilution Parameters

WBC/BASO WBC, Baso #‚ Baso %

Flow CytometryDiode laser - 1:50

4 Diff Flow cytometryDiode laser - 1:51

Lymph #‚Lymph %, Mono #, Mono %, Eo #, Eo %, Neut #‚ Neut %

RET/PLT-OFlow cytometry

Diode laser - 1:204RET #, RET%, PLT-OHFR , MFR , LFR, IRF

HGB SLS-Method, Photometry1:500

HGB

RBC/PLT-Detector

RBC, HCT, PLT-I, RDW-SD, RDW-CV, PDW, MPV, P-LCR

HDF DC-Detection methodImpulse summary

1:500

MCH, MCHC, MCV


Fluorescence Flow CytometryFluorescence Flow Cytometry

Semiconductor Laser

( = 633nm)

Flow Cell

Photo Diode(Forward Scattered Light)

Photo Multiplier(Side Scattered Light)

Photo Multiplier(Fluorescence Light)

DichroicMirror



Forward Scattered Light:Cell Volume Information

Laser Beam

( = 633nm)

Side Fluorescence Light:RNA/DNA Information

Side Scattered Light:Internal Cell Structure


4 Diff-Channel4 Diff-Channel

2. DIFF-Scattergram

1. Principles and technology


4 Diff-Channel 4 Diff-Channel

Neutrophil

Eosinophil

Basophil Monocyte

Lymphocyte

Band Myelocyte

Promyelocyte BlastMetamyelocyte

Neutrophil

Eosinophil

Basophil Monocyte

Lymphocyte

Lyse & Staining

Band Myelocyte

BlastMetamyelocyte

Promyelocyte



DIFF Scattergram Mono

Neut + Baso

Lymph

Eo

Side Scatter

Fluorescence

Ghost


4 Diff-Channel 4 Diff-Channel (pathological sample)(pathological sample)

DIFF Scattergram

Side Scatter

Fluorescence


Diff ScattergramDiff Scattergram

Band

Metamyelo

Myelo

Promyelo

Abn. Lymph/Blasts

Atypical Lymph


WBC/Baso ChannelWBC/Baso Channel

2. DIFF-Scattergram




Lyse Lyse

Neutrophil

Eosinophil

Basophil Monocyte

Lymphocyte

Neutrophil

Eosinophil

Basophil Monocyte

Lymphocyte



WBC/BASO Scattergram

Baso

WBC

Side Scatter

Forward Scatter


RET ChannelRET Channel

2. DIFF-Scattergram



Ret ChannelRet Channel

Lyse & Lyse & StainingStaining

Staining: Polymethine: RNAOxazine: DNA

RBC RET PLT NRBC WBC

RBC RET PLT NRBC WBC



IRF

Forward Scatter

Fluorescence

PLT-O

RET(LFR, MFR, HFR)

RBC

RET Scattergram


HDF TechnologyHDF Technology

2. DIFF-Scattergram



Hydrodynamic FocussingHydrodynamic Focussing

. DC resistance measurement with hydrodynamic focussing for measurement of erythrocytes, thrombocytes and hematocrit

CELLPACK (Sheath solution)

Aperture

Sample


aperture

Pulse A

C BA

cells

Hydrodynamic FocussingHydrodynamic Focussing

Pulse B Pulse C


HemoglobinHemoglobin

2. Reaction Mechanism

1. SLS


SLS-Hemoglobin SLS-Hemoglobin

.Cyanide free SLS-Method

.Alternative for KCN

.SLS is Sodium lauryl sulphate

.Equal to the KCN method

.Cyanide free, not poisoned, is part of a lot of soaps

.Sysmex Sulfolyser is used for K-, E-, NE, SF, SE and and XE-instruments

.The SLS-Method is Standard for Sysmex instruments


Reaction Mechanism of HemoglobinReaction Mechanism of Hemoglobin

Hydrophobic group

Hydrophilic group

SLS (Sodium Lauryl Sulfate)

Heme

Globin

Hemoglobin-Molecule


Reaction Mechanism of HemoglobinReaction Mechanism of Hemoglobin

2. 0xidation of Ferro: Fe2+ --> Fe3+

1. Hydrophobic groups of SLS binds to globulin

3. Hydrophilic groups of SLS binds to Fe3+. and SLS-Hgb is formed

XT XT

Flagging SystemFlagging System


FlagFlag

.NEGATIVE

.No abnormality

.POSITIVE

.One or more of the IP messages is generated

.ERROR

.Classified as Functional abnormality

.Classified as Result, Low reliability


Result

NEGATIVE

POSITIVE

Report

Review Report

XT flagging system can provide valuable information for review

Error Review Report

XT Flagging SystemXT Flagging System


FlaggingFlagging

Low Reliability of Data

POSITIVE

Diff

Morph

Count

ERROR

Func

Result

Delta

Abnormality in Cell Differential

Abnormality in Cell Morphology

Abnormality in Cell Count

Analysis error other than ID Barcode

Abnormalities with Delta Check


IP MessageIP Message

Two Types

.Abnormal IP Message:

. Indicates that the sample is definitely abnormal. The IP abnormal message criteria can be set except for some items.

.Suspect IP Message:

. Indicates that there is a possibility that the sample is abnormal.


IP messageIP message

. IP messages are detected from:

. Cell information

.Fluorescence

.Forward Scatter Light

.Side Scatter Light

. Scattergrams

. Histograms

Flowcytometry


WBC FlaggingWBC Flagging

Abnormal Messages

. WBC abnormal Scattergram

. Neutropenia

. Neutrophilia

. Lymphopenia

. Lymphocytosis

. Monocytosis

. Eosinophilia

. Basophilia

. Leukopenia

. Leukocytosis

Suspect Messages

. Blasts?

. Immature Gran?

. Left Shift?

. Atypical Lympho?

. Abn Lympho/L-Blasts?

. RBC Lyse Resistance?

. NRBC?


RBC FlaggingRBC Flagging

Abnormal Messages

. RBC ABN Distribution

. Dimorphic Population

. Ret ABN Scattergram

. Reticulocytosis

. Anisocytosis

. Microcytosis

. Macrocytosis

. Hypochromasia

. Anaemia

. Erythrocytosis

Suspect Messages

. RBC Agglutination?

. Turbidity / HGB inter

. Iron Def?

. HGB Defect?

. Fragments?


PLT FlaggingPLT Flagging

Abnormal Messages

. PLT ABN Distribution

. PLT ABN Scattergram

. Thrombocytopenia

. Thrombocytosis

Suspect Messages

. PLT Clumps ?

. PLT C(s) ?

Product PortfolioProduct Portfolio

Current and FutureCurrent and Future


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Current MCC PortfolioCurrent MCC Portfolio

Low end Middle High end

Price


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Price

XE-2100L XE-2100

F series

KX-21/KX-21N

K-4500

SF-3000

SE/R

SE


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Price

Pentra-60AcT 5 DiffADVIA 70

MicrosCD-1200Act DiffⅡ

ADVIA-120

CD-4000

Gen*S/LH750

Pentra-120R

HmXCD-3700Pentra-120CD-3200


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Price



ADVIA-120

CD-4000

Gen*S/LH750

Pentra-120R


XE-2100L XE-2100

F series

KX-21/KX-21N

K-4500

SF-3000

SE/R

SE


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MCC Portfolio - Future -MCC Portfolio - Future -


Price



ADVIA-120

CD-4000

Gen*S/LH750

Pentra-120R


XE-2100L XE-2100

F series

KX-21/KX-21N

K-4500

SE/R

SEXT-2000i

XT-1800i

DifferencesDifferences

XT-2000i & XE-2100XT-2000i & XE-2100

Sysmex

XE-2100


XT-2000i XE-2100

Parameters 30 32

Throughput CBC 80 samples/hour

150 samples/hour

+ RET

80 samples/hour

113 samples/hour

Discrete mode 4 7

Sample Volume

Manual

85 uL 130 uL

Closed

150 uL 200 uL

Sample No digit 15 15

Sampler 50 samples 100 samples

SpecificationsSpecifications


ParametersParameters

XT-2000i XE-2100

Reportable

CBC Yes Yes

DIFF Yes Yes

RET Yes Yes

PLT-O Yes Yes

NRBC No Yes

Research HPC No Yes

IG Yes Yes


ReagentReagent

XT-2000i XE-2100

CELLPACK use use

CELLSHEATH not use use

STROMATOLYSER-FB

use use

STROMATOLYSER-4DL

use use

STROMATOLYSER-4DS

use use

STROMATOLYSER-IM not use use

SULFOLYSER use use

STROMATOLYSER-NR

not use use

RETSEARCH II use use


IPUIPU

XT-2000i XT-1800i XE-2100 XE-2100L

OS Windows 2000 Windows NT*

Database SQL-Anywhere 5.5.05

SQL-Anywhere 5.5.04

CPU > Pentium III 733 MHz

> Pentium II 450MHz

Memory > 128MB > 64Mb

HDD > 10 GB > 3 GB

ATA > 100 -

result 10,000 10,000

workload 1,000 1,000

Patient Information

5,000 5,000

QC files 21 files (300 points/file)

21 files (300 points/file)

Sto

rage

* The OS of XE will be changed to Windows 2000 from Ver. 19


Difference: IPUDifference: IPU

Measure Sample - analysis result - differential - flagging

Measure Sample - raw data

Store the results

Analysis the raw data- differential- flaggingStore the results

Sysmex

XE-2100

XE-Series

SysmexXT-2000i

XT-Series

OS: Windows NT

OS: Windows 2000


Coffee breakCoffee break


XT-2000XT-2000ii

FeaturesFeatures


FeaturesFeatures

1.Flowcytometry2.Multi Channel Analyzer3.Semi Conductor Laser4.Network5.Fully Automated RET analysis (XT-2000i)6.Random access testing7.Common operation & reagent system with XE8.Hydrodynamic Focusing System9.Effective Hematology Information10.SNCS11.X-bar-M Control12.Q-Flag

FeaturesFeatures

FlowcytometryFlowcytometry


Principle in HematologyPrinciple in Hematology

.Resistance

.Optical Measurement


Optical PrincipleOptical Principle

.Scatter light

Information

Forward-scatter

Cell volume

Side-scatter

GranularityInternal Cell Structure


DNA/RNA-Content Cell cyclesCell proliferationReticulocytesChromosome..


. Fluorescence



Light source:

. Tungsten lamp

. He-Ne laser

. Argon laser

. Semiconductor laser

Forward-scatter Fluorescence

Side-scatter

Semi conductorlaser

Tungsten lamp

He-Ne-Laser

Argon laser



Definition:

. Is an optical system which detects scatter light and fluorescence of sheath flow focussed single cells



Argon laser

. Wavelength = 488 nm

Staining (RET)

. Acridine orange, Ethidium bromide, Thiazole orange, Auramine O

Semiconductor Laser

. Wavelength = 633 nm

Staining

. on basis of Polymethine for fluorescence optical detection

. with long stability and high fluorescence gain

. Fluorescence stimulation with semiconductor laser


Formula of Polymethine Formula of Polymethine

X=O, S, Se, N-alkyl or C(Ch3)n

R1,2 = alkyl (1-6C) ;

R3,4 = alkyl, metoxy or no

n = 0-1



How does SYSMEX use the new technology?

.Diff

.Reticulocytes


Flowcytometry with XT-SeriesFlowcytometry with XT-Series

What is so special on it ?

.There is Forward and Side Scatter, a lot of information’s about nucleus and granularity! Why Fluorescence?

.Why is that so new ?Other are also offering IG count!


Flowcytometry with XT-SeriesFlowcytometry with XT-Series

What is so special?

Polymethine stains DNA/RNA, however important is

staining including RNA, and the use of these reagents make supra vital staining possible. Beside the information of - Cell volume - Intracellular components ,nucleus and granularity we get also information about the Cell Activity - Replication activity of the nucleus

(cause high RNA) - Cytoplasm activity

(Protein syntheses causes high RNA)


1 2

3

8

4

5 6

10

7

The CellThe Cell


The CellThe Cell

. Cell nucleus (1)

(DNA) . Function: Auto replication and syntheses Ribonucleinacid (RNA) in the Nucleolus (2) Cells with no possibility of replication have less RNA.These are mature cells (except lymphocytes) and NRBC (except pro erythroblast)

. Cytoplasm (3)

- Mitochondria (5) energy factory no RNA/DNA- Golgi machine (4) pack up enzymes no RNA/DNA

- Endoplasmatic Reticulum (10) is a membran structure with Ribosome (RNA) for protein synthesis (not in RBC)

- Lysosomen (8) Granula no RNA/DNA, enzymes

1 2

3

8

45 6

10

7



Neutrophil

Eosinophil

Basophil Monocyte

Lymphocyte

Band Myelocyte

Promyelocyte BlastMetamyelocyte

Neutrophil

Eosinophil

Basophil Monocyte

Lymphocyte

Band Myelocyte

BlastMetamyelocyte

Promyelocyte

Lyse & Staining

FeaturesFeatures

Semiconductor LaserSemiconductor Laser



Semiconductor Laser

( = 633nm)

Flow Cell

Photo Diode(Forward Scattered Light)

Photo Multiplier(Side Scattered Light)

Photo Multiplier(Fluorescence Light)

DichroicMirror

Optical System


Semiconductor LaserSemiconductor Laser

Feature

. Long-life Laser

. Saves money

. Quick start-up

. Stat samples

. Compact

. Less space – small analyser

. Low power consumption

. Save money

. High stability

. Less maintenance cost

FeaturesFeatures

Fully automated RET Fully automated RET analysisanalysis


Fully automated RET analysisFully automated RET analysis

. Just 60 seconds analysis

.No pre-treatment

.Useful information

. IRF, LFR, MFR, HFR

Fast reportLess laborProvides valuable information


IRF for monitoring of erythropoesisIRF for monitoring of erythropoesis

.Ratio of immature reticulocyte

.Useful predictive parameter of

.bone marrow suppression

. recovery in terms of erythropoesis

FeaturesFeatures

Efficient Hematology Efficient Hematology InformationInformationOptical Platelets Optical Platelets

PLT-flPLT-fl

Atypical LymphAtypical Lymph

IG CountIG Count

FeatureFeature

Optical Platelets PLT-flOptical Platelets PLT-fl


Fluorescence PLT CountFluorescence PLT Count

If there is a problem with the size of RBC and PLT,

than the impedance count often is not enough.

. Pseudo thrombopenia : - Giant PLT - PLT Aggregation

. Pseudo thrombocytose: - Fragments

A chamber count (lysed RBC) or a flow cytometry measurement CD 61 (membran antigen) or a check of the RNA is requested.


““Optical” PLT CountOptical” PLT Count

. Impedance platelet analysis has limitations in the identification and discrimination of platelets from interfering particles

. RBC fragments (similar in size to PLT)

.Counted as platelets

. Small RBC (similar in size to PLT)

.Counted as platelets

. Large platelets (similar in size to RBC)

. Excluded from the platelet count


Fluorescence PLT

X



RBC ratio v XE (PLT-i)

y = 0.9047x + 2.1817r = 0.8852

0

30

60

90

120

150

0 30 60 90 120 150

RBC ratio x 10 ^9/L

XE (P

LT-i)

x 1

0 ^9

/LRBC Ratio v XE (PLT-o)

y = 1.0068x + 1.8778r = 0.9735

0

30

60

90

120

150

0 30 60 90 120 150

RBC ratio x 10 ^9/L

XE

(PLT

-o) x

10

^9/L

Immunocount versus XE impedance count

Immunocount versus XE “optical” count

PLT < 100 X 10PLT < 100 X 1099/L vs. Immunocount/L vs. Immunocount


Results

XE2100 (PLT i) versus CD61

• All counts R²=0.98• PLT <100 R²=0.78

XE2100 (PLT fl) versus CD61

• All counts R²=0.97• PLT<100 R²=0.95




Reliable PLT Count

With the addition of the optical method for PLT counting, the XT-2000i

Can automatically report reliable PLT counts when interferences with

The impedance method are detected


PLT-I and PLT-FL Switching AlgorithmPLT-I and PLT-FL Switching Algorithm

PLT-I, unreliable

PLT-O, unreliable

PLT Vote out

PLT-I Result

PLT-O Result

No

Yes

Yes

No





Dysplastic Thrombocytes (MDS)Dysplastic Thrombocytes (MDS)

. Dysplastic Erythrocyte (could be with Fragments)

. Dysplastic Thrombocyte (possible with degranulated PLT)

. Problem with Impedance and FSC and SSC (7°).


Dysplasia (MDS)Dysplasia (MDS)

90% of all measured Fragments are related to MDS

In case of MDS:

dysplastic Erythrocytes (Fragments)

dysplastic Platelets (degranulated)

Problems with Impedance and optical Measurement (FSC and SSC (no granularity)), only fluorescence RNA is possible.

FeaturesFeatures

IG CountIG Count


Maturation of neutrophil

promyelo myelo metamyelomyeloblast band segment

IG

IG CountIG Count

.Useful information on WBC extended differential (Not reportable - research parameter)

. IG:

.promyelocyte

.myelocyte

.metamyelocyte



Band

Metamyelo

Myelo

Promyelo


Immature Granulocytes Immature Granulocytes


Immature Granulocytes Immature Granulocytes


y = 1.2278x - 0.7245

R2 = 0.8751

0

5

10

15

20

25

30

35

0 5 10 15 20 25 30

XE-2100 IG%

MIC

RO

IG

%

No. samples: 134

XE-2100 range: 1.0-24%

MICRO range: 0.0-33.0%

Inaccuracy of IG proportionInaccuracy of IG proportion

FeaturesFeatures

Atypical LymphAtypical Lymph



Band

Metamyelo

Myelo

Promyelo

Abn. Lymph/Blasts

Atypical Lymph


Atyp. LymphAtyp. Lymph


Activated B-Lymphocytes





Comparison: XT vs. ADVIAComparison: XT vs. ADVIA

LUC - What is that ?

Blast or Blast-like

. ALL or AML

. NHL (IB or CC-CB)

Large Lymphocytes

. Activated T-Cells

. Activated B-Cells

. O-Lymphocytes

. NHL all kinds.

Monocytes (Low perox.)

. CMML

. Macrophage



The result was Other: 11.5%, LUC: 10.8% and manual: 9% respectively,

it showed excellent correlation.


Big differences between Other: 0.1% and LUC: 15.3%, but the result of manual method was Atyp. Lymph 0.5% and Monocytes: 40%. It is considered that LUC includes Monocytes



SummarySummary

.XT-2000i gives information about replication activity of the nucleus (higher RNA content)

.XT-2000i gives information about cytoplasm activity (Protein syntheses high RNA)Sub-population for B-lymphocytes.

.Separates Lymphatic diseases from others

.No problem with Giant-PLT or Fragments (PLT-fl)

.XT-2000i provide a total count of IG´s (Sepsis)

FeaturesFeatures

Network capacity Network capacity


NetworkNetwork

.The XT can be integrated into computer network

Room A

Room BRoom C

PC room

Sysmex

XE-2100

Doctor’s room

NETWORK


Network ConnectionNetwork Connection

Hospital Information System

Clinical Laboratory (1)

Clinical Laboratory (1)

Laboratory Information System

Features Features

Quality ControlQuality Control


.24 files for either x bar or L-J

.1 file for x bar M

.300 points each file

.Delta checking is also available for cumulative review


Primary Goals in Quality ControlPrimary Goals in Quality Control

.Error Detection

.Error Prevention

.Reliable Test Results


Errors of Laboratory MeasurementsErrors of Laboratory Measurements

. Random errors are the result of chance or sampling errors.

. Random errors do not affect the entire batch of specimens


Systematic Error Systematic Error

. Systematic errors affect all specimens in a batch.

. Systematic errors are attributed to causes other than chance: e.g., deteriorating reagents, instrument malfunction.

FeaturesFeatures

X-bar-M ControlX-bar-M Control


Patient Moving AveragePatient Moving Average

.Quality control tool developed by Dr. Brian Bull in 1974.

.This algorithm is based on the inherent stability of the red blood cell indices in a general hospital populations.

.Utilizes patient data, recording the MCV, MCH and MCHC of each patient sample.

.Monitors stability over time of:

. Instrumentation

.Reagents

.Technique


FeatureFeature

.Use of routine samples

.Fresh blood, cells without fixation, optimal to check lyse processes

.NO additional costs, because the control runs in the back ground with routine samples

.no manual handling

.Optimal controlling of reagents

.especially after reagent change


FeatureFeature

. Check of the analyzer every 20, 30, 40 or ... (corresponding batch size)

. Longtime and continuing control

. QC is only one shot

.No optimal check of reagent

.Check of dilutions

.Check of lyse processes limited


Advantages of x-bar-m controlAdvantages of x-bar-m control

. Inexpensive, simple to use

.Utilizes unfixed patient blood

. Incorporated into current Hematology analyzers

.Real time QC

FeaturesFeatures

Online QCOnline QC


On-line QCOn-line QC


Online-QC on the XE-2100Online-QC on the XE-2100

. Internal & External QC simultaneously

.Daily Data Comparison against Reference and Peer Group Values

.QC-Error Detection in Real-Time by Means of a QC-Flag System


Categories of Quality ControlCategories of Quality Control

. IQC

.Available anytime, butif any abnormality found...

. Instrument condition?

.Control Blood Problem?

EQC

.Not Available anytime

. Long period to get statistics Result


1111

Action Limit flag

If data exceeds Group Mean +/- Action

Limit triggers QC-error mail

SDI Limit flag

When data exceeds Group Mean +/- 3SD

Reproducibility flag

When data deference against the

previous QC data in SDI is more than “4”, Trend flag

When SDI increased or decreased continuously 6 times

QC flagging InformationQC flagging Information

FeaturesFeatures

Remote MaintenanceRemote Maintenance


Remote ServiceRemote Service

Line for Remote Support Sysmex

SupportCenter

Line forRemote Support

ClinicalLabs


SNCS ConceptSNCS Concept

FeaturesFeatures

Random Access TestingRandom Access Testing


Random Access TestingRandom Access Testing

CBC

CBC + DIFF

CBC + DIFF + RET

CBC + RET

.Real-time random access testing

. Quick report

. Cost saving

Various types of real-time discrete analysis modes save on reagent

FeatureFeature

XE / XT Family ConceptXE / XT Family Concept


Operation & reagent system with XEOperation & reagent system with XE

.Solution for

. HST (XE) series: Core lab.

. XT series: for satellite lab.

Core Lab

Same ReagentsSame Results

Same Operation

FeaturesFeatures

Hydrodynamic FocusingHydrodynamic Focusing


Hydrodynamic Focusing SystemHydrodynamic Focusing System

. New system

. Compact

. Prevent re-circulating and coincidence

. No Cellsheath required

Less maintenanceMore accurate result in RBC and PLT

CELLPACK (Sheath solution)

Aperture

Sample

FeaturesFeatures

Q-FlagQ-Flag


Unique Q-Flag SystemUnique Q-Flag System

. Q-Flag system visualizes level of each sample abnormalities and allow to perform the patient monitoring effectively.

. Quantitative monitoring of suspect flags:

. Blasts?

. Imm Gran?

. Left Shift?

. Atypical Ly?

. Abn Ly/Blasts?

. RBC Lyse Res?

. RBC Agglut?

. Turb/HGB?

. HGB Defect?

. Fragments?

. PLT Clumps?


Q-Flag SystemQ-Flag System

300

200

100

80

BLASTS ?300

200

100

250

BLASTS ?

IP Message

Numerical value of the bar height

Red, ifabove 100

Green, ifbelow 100

Sysmex Q-Flag system gives the operator the full picture.


Degree of the abnormality Trigger

level

Blasts? Imm Gran?Left Shift?

Positiveexample

Negativeexample

Q-Flag SystemQ-Flag System

FeaturesFeatures

ACAS - ACAS - Adaptive Cluster Analysis Adaptive Cluster Analysis SystemSystem


ACAS ACAS Adaptive Cluster Analysis SystemAdaptive Cluster Analysis System


ACASACASACAS

1. Analysis of the first 500 signals of cells with moving centroids.

2. Determination of clusters of lymphocytes granulocytes, monocytes and ghost when analysing 1000 signals of cells.

3. Repitition of steps 1 and 2 until the values are stabil (max. 5 times), I. e. the centroides are in a fixed position.

4. If the differences are not stable after the 5. repetition, there will be no separation of WBC populations (grey area).

5. Adaptive Cluster Analysis System is done for all counted leucocytes (f.e. 25.670 cells, if the WBC concentration is 25,67 x 10^3/µL).

6. Result: Very exact differentiation, compared to flowcytometrie and the manual mikroscopic differential.

7. Result: Good differentiation even in pathological and older samples (24 h).


Position StatementPosition Statement


Purpose Positioning StatementPurpose Positioning Statement

It’s up to us to choose :

the image or perception

However we intend to generate in the customer´s mind


Position Statement ElementsPosition Statement Elements

. Images or Perception

.Customer Target Groups

.Competitor Target

.Core Strategy

Images or PerceptionImages or Perception


Image or perception we intend to Image or perception we intend to generate in customer’s mind:generate in customer’s mind:

.State of the art

.we continue to deliver what we promise in time reliable and innovative products

.Appealing Software

.Unique menu of clinically relevant parameters

.PLT-fl

. IG

. Fluorescence : ‘brightest’ hematology system



. Is it IT or is it Haematology ? It is the best of both !

.The only true WBC count

.21st Century laboratory management concept

.perfect combination between research and routine

.High class full hematology

.a system for eXperTs

.Network connectivity



.Perfect link between technology and organisation

. the golden combination

. selectivity : cost effective

. compact



. Fluorescence Activated Differential (F.A.D.) :

.a new standard in WBC-differential:the DIFF is stained, therefore optimum quality

.True Selectivity : random access profiling:CBC, CBC+DIFF, CBC+DIFF+RET, CBC+RET

. reduce running costs and increase efficiency

.New parameters: IG, PLT-fl, RBC-O

.a world of new important information



.The top of the range analyzer made by Sysmex

.a high quality product of a successful range

.High Tech : Windows 2000, Dual, QC, Maint.

.Up-to-date computer system

. Latest Laser Technology : Diode Laser

. Long life, trouble free high stability

Customer Target GroupsCustomer Target Groups


Positioning StatementPositioning Statement

Customer Target Groups:

. the Scientist

. the Altruist

. the Money Maker

. the Lab-manager


Target Group: the Scientist Target Group: the Scientist

The XT-2000i delivers several important new parameter to be evaluated:

. IG % and IG #

.80 % of all diseases have an increased IG

. further reduction of manual diff!

.Better accuracy for IG detection!

.PLT-fl

.Monitoring of Anemia

.New Parameter: RBC-Y and RET-Y


Target Group: the AltruistTarget Group: the Altruist

The XT-2000i delivers several important new parameter which improve Patient Care:

. IG count: fast and reliable

.PLT-fl: correct PLT count even at fragmented RBC or PLT-clumps

.RBC-O: correct RBC count also at agglutination

. IG % at low concentrations : the only clinical indicator for some diseases


Target Group: the MoneymakerTarget Group: the Moneymaker

The XT-2000i delivers several important new innovations which improve efficiency:

. full selectivity reduces costs/test

. IG count reduces manual differentials further


Target Group: the Lab-ManagerTarget Group: the Lab-Manager

The XT-2000i delivers several important high tech features which improve lab-service:

.Windows 2000 software

.Online QC support

.Online Maintenance

.Online Application Support

.Online Service Support

. Internet Communications

Competitor TargetCompetitor Target


Competitor Target BayerCompetitor Target Bayer

Position themselves as THE differential counter

.Where is the IG count ?

.How about peroxidase deficiency ?

.What about maintenance ?

.What's about degranulated cells


Competitor Target AbbottCompetitor Target Abbott

Worked hard to become the new standard

.Did not make it (only a few CD-4000 installations world wide)

.No real flowcytometry with fluorochrome

.9 part diff ? No scientific evidence

.Reliability problems: pinch valves, no SRV


Competitor Target CoulterCompetitor Target Coulter

.Used to be Nr. 1

.No random access selectivity

.No IG

.No innovations

. Just a Max-M repacked: old technology


Competitor Target ABXCompetitor Target ABX

.A newcomer

.No random access selectivity

.No IG

.No Dual System

.Not fast

Core StrategyCore Strategy


Core Strategy MMCore Strategy MM

Convince the money-maker that …………...the XT-2000i improves his lab-efficiencydramatically and in a unique way because :

. the IG count reduces his manual differential count further

. full selectivity reduces his costs/test


Core Strategy ACore Strategy A

Convince the Altruist that ………………….The XT-2000i produces reliable results on new parameters which improve the healthcare of his patients because :

.PLT-fl: correct PLT count even at appearance of Fragments

.RBC-O: correct RBC count also at agglutination

. IG count provided within 30 seconds: inflammation and sepsis (I/T ratio)


Core Strategy SCore Strategy S

Convince the Scientist that ……..The XT-2000i is the superb analyser which provides a lot of scientific important parameters to be investigated for clinical relevance/importance because:

.How powerful is IG% and IG# in detecting sepsis in an early stage ?

.At what diseases IG appearance at the same time in the same in the peripheral blood ?


Core Strategy LMCore Strategy LM

Convince the Lab-manager that ………..the XT-2000i has a powerful impact onto his lab-organisation because:

. the Windows 2000 is so easy to operate by all people

. the Internet-connection allows him to communicate : QC-results, application issue’s, maintenance, service support

.powerful QC-package

.adjust screens to his needs: flexibility


The END!

EndeEnde

Health & Medicine

Xt 2000i cell counter Autoanalyser