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Restricted © Siemens Healthcare Diagnostics Inc. 2014 All rights reserved. Answers for life.
Siemens: Innovative Trends in Hemostasis
Herbert Maier / November 2014 Martin/SK
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CS-5100with Cap Piercing
CS-2100i with Cap Piercing
CS-2000iw/o Cap Piercing
… Sysmex® CS-Series
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INNOVATION through Sample - Quality Check
HIL – Check
Hemolytic – Icteric – Lipemic
through simultaneous multi wavelength analysis
Innovation Highlight with the CS-series
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Influence of Hemolysis on COAGULATION Results
Source: Lippi et al (2006)
PT
Fib
PTT
D-Dimer
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SAMPLE UNDERFILLING – Effect of citrate concentration
• Minimum fill volume:
0.109M citrate
• PT (Innovin) 60%• APTT (Actin FS) 70%
• 0.129M citrate
• PT 70%• APTT 90%
(Adcock et al 1998)
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Innovation Highlight with the CS-series
Hemoglobin
0
1
2
3
4
300 450 600 750 900λ
Ab
s
Triglyceride
0
1
2
3
4
300 450 600 750 900λ
Ab
s
Bilirubin
0
1
2
3
4
300 450 600 750 900λ
Ab
s
Only SYSTEM with AUTOMATIC CHECK for SAMPLE INTERFERENCES
800nm405nm
575nm660nm
340nm
The pre-analytical sample check guarantees
the result reliability and eliminates the most
frequent cause of errors in measurement:
Interferences in sample material
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340
800
575
405 600
1st volume check
2nd volume check
Probe 1 Probe 2
Pre-analysis Analysis Results
70%1 30%!
Hemolytic
Icteric
Lipemic
!
Pre-analytical Sample Integrity (PSI) Checks
Upper level
Lower level
1. Lippi G, Banfi G, Buttarello M, et al. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med. 2007;45(6):728-736.
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340
800
575
405 600
Results Accuracy
300 400 500 600 700 800
Wavelength (nm)
Absorbance
Hemolytic
!
LipemiaHemolysisIcterus
Correct first time
Pre-analysis ResultsAnalysis
70%1 30%!
1. Lippi G, Banfi G, Buttarello M, et al. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med. 2007;45(6):728-736.
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Fully Traceable Results
Operator ID
Time and date
Calibration curve and measurement result information
Operation and error logs
Maintenance and QC history
Automatic backup and data storage
Report
Certificate
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Ease of Use
Real-time reagent and consumable monitoring
QC procedures
Results validation
Configurable maintenance
CS systems
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Features CS-Series– Reagent handling
40 cooled Reagents
High on-board Stability
Low dead volume through tilted
reagent positioning
Multi lot management
Cooled down to 8-10°C
Up to 120h
Positive barcode identification of
all reagents, controls and
standards at every position
ECONOMIC & FLEXIBLE
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Features CS-Series – Instrument Operation
TWO - DIMENSIONAL BARCODE
Simple, Save, Efficient
Allows the automated data input into the system software:e.g. lot specific values
Calibrators – nominal values Controls – target values & ranges PT-reagents – ISI, derived Fibrinogen
Avoids misentry and is immediately available with the new reagent
USER FRIENDLY OPERATION
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USER FRIENDLY OPERATION
Features CS-Series – Instrument Operation
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Features CS-Series– Test portfolio
COMPREHENSIVE TEST PORTFOLIO
Routine
Bleeding risk
Fibrinolysis
Thrombophilia
Monitoring
vWF:Risto*
ETP*
The broad test portfolio, combined with multi- lot-
management guarantees a high degree of specialization.
UP to 10 calibration curves per reagent can be stored and
displayed in a clear software menu.
Multiple lots per reagent can be loaded on board and
facilitate the workflow
*in preparation
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Features CS-Series – THROUGHPUT
CS-2000i CS-5100 Parameter Tests/h Tests/h
Profile A/h PT* 180 400
Profile B/h APTT* 180 400
Profile C/h PT and APTT 180 400
Profile D/h PT, APTT, ATIII 94
Profile E/h PT, APTT, ATIII, INN DD 96 313
*Thromborel S and Pathromtin SL
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ADVIA® LabCell® Automation Solution
Aptio™ Automation System
ADVIA CentraLink® Data Management System
ADVIA® LabCell® Automation Solution
Aptio™ Automation System
Connectivity Sysmex® CS-5100
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Sysmex® CA 660: Reliable and proven technology
+ 2D barcode reader simplifies daily work
+ Increased throughput for D-dimer*
Same proven technology as theSysmex CA-500 Systems
+ Improved graphical display of reaction curves
*Available only on CA-660
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LAS Connectivity; a smarter solution
• True “Point in Space” design according to CLSI standards. A more efficient transfer of the sample (not the tube) from the track.
• Integration of the system SW with the LAS control SW; more information is communicated.
• Manual sample loading option in case of LAS stoppage
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Consistent Results
ResultsResults
!Results
Results
CA 600 CS-2100i CS-5100
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INNOVANCE® VWF AcAn new assay for Von Willebrand activity testing
Herbert Maier / November 2014 Martin/SK
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VWF-A1 GpIbα
VWF Ac – a particle enhanced GPIb binding assay
There are two naturally gain-of-function mutations in the recombinant GPIbα fragment: G233V and M239V
Due to the high affinity VWF can bind without the support of ristocetin to the mutant rGPIbα
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New: INNOVANCE VWF Ac
innovative technology using recombinant GPIb receptor
real functional assay for detection of quantitative and qualitative VWF deficiencies
turbidimetric, latex based assay - no need for stirring
use of gain-of-function GPIb receptor mutation - no need for ristocetin
excellent precision and lot-to-lot consistency
available on all Siemens automated coagulation instruments
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INNOVANCE® Free PS AgAn assay for easy, specific, and stable protein Santigen testing
Herbert Maier / November 2014 Martin/SK
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Intended Use and Assay Principle
INNOVANCE® Free PS Ag Assay
For the quantitative determination of free protein S in human plasma
Assay principle:
• Particle-enhanced immunoassay
• Quantitative determination of free protein S using polystyrene particles covalently coated with monoclonal antibodies
• Turbidimetric detection
• Excellent specificity
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INNOVANCE® Free PS Assay Principle
Turbidimetric detection of aggregatesFree protein S from
human plasma
Latex particleswith antibody A
+
+
Latex particleswith antibody B
Antibodies do not bind to protein S/C4b-binding protein complexes
†Own development
2 Mab† binding only free PS, Ag
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The Sysmex® CS-Series
Thank you