Restricted © Siemens Healthcare Diagnostics Inc. 2014 All rights reserved.Answers for life. Siemens: Innovative Trends in Hemostasis Herbert Maier / November

Restricted © Siemens Healthcare Diagnostics Inc. 2014 All rights reserved. Answers for life.

Siemens: Innovative Trends in Hemostasis

Herbert Maier / November 2014 Martin/SK

Unrestricted © Siemens Healthcare Diagnostics Inc. 2014 All rights reserved.HM Nov. 14Page 2

CS-5100with Cap Piercing

CS-2100i with Cap Piercing

CS-2000iw/o Cap Piercing

… Sysmex® CS-Series


INNOVATION through Sample - Quality Check

HIL – Check

Hemolytic – Icteric – Lipemic

through simultaneous multi wavelength analysis

Innovation Highlight with the CS-series


Influence of Hemolysis on COAGULATION Results

Source: Lippi et al (2006)

PT

Fib

PTT

D-Dimer


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)


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


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.


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.


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


Ease of Use

Real-time reagent and consumable monitoring

QC procedures

Results validation

Configurable maintenance

CS systems


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


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


USER FRIENDLY OPERATION

Features CS-Series – Instrument Operation


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


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


ADVIA® LabCell® Automation Solution

Aptio™ Automation System

ADVIA CentraLink® Data Management System

ADVIA® LabCell® Automation Solution

Aptio™ Automation System

Connectivity Sysmex® CS-5100


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


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


Consistent Results

ResultsResults

!Results

Results

CA 600 CS-2100i CS-5100


INNOVANCE® VWF AcAn new assay for Von Willebrand activity testing



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


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


INNOVANCE® Free PS AgAn assay for easy, specific, and stable protein Santigen testing



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


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


The Sysmex® CS-Series

Thank you

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Restricted © Siemens Healthcare Diagnostics Inc. 2014 All rights reserved.Answers for life. Siemens: Innovative Trends in Hemostasis Herbert Maier / November