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Passion for Coagulation with Roche Diagnostics Vth National Conference of Clinical Laboratory “Sunny Beach Resort�, Bulgaria 24th September 2009 Martina Woppmann, Roche Diagnostics


Contents

• Roche Passion for Coagulation • Clinical Value - D-Dimer - Anticoagulants monitoring – The choice is yours • Laboratory Efficiency - Roche products efficient coagulation testing - STA concept and viscosity-based detection for outstanding quality

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Passion for Coagulation

Helping to improve patient care and diagnostic efficiency

Laboratory Automation

Routine- & Special Testing

Health Care Professionals

Central Labs Commercial Labs

ICU

Self- and Professional Monitoring

Patients

ER

Outpatients Self Testing


Medical value in coagulation

Medical value is defined by clinical & economic value Clinical value

+

Medical relevance & patient need Disease identification: Thrombophilia (Thrombosis/DIC/Protein Resistances) Bleeding Tendency (Factor Deficiencies/vWF) Better treatment decisions & close monitoring: In anticoagulant therapy (intensive care/outpatient) In critical patient states (shock/sepsis)

Laboratory Efficiency

Improve health outcomes & resource Optimizing processes of care: D-Dimer in exclusion of DVT or PE Anti-Xa in Heparin monitoring reducing bleeding events & related complications Reduced length of stay: Prevention of critical complications reduces hospital stays & corresponding costs

Improved patient outcomes: Proper diagnosis has potential to prevent strokes, myocardial infarction, arterial/venous thrombosis, necrosis, etc.

4


Clinical relevance of coagulation testing (I/II)

Tendency to CLOT (Thrombophilia) Arterial/Venous Thrombosis D-Dimer, Lupus Anticoagulants Disseminated Intravascular Coagulation D-Dimer, Fibrinogen, Soluble Fibrin)

Manifestatio n

Pulmonary Embolism (PE) Deep Vein Thrombosis (DVT) Organ failure, necrosis

Factor Mutations (FII, FV) (Factor II Prothrombin, Factor V Leiden)

PE, DVT, other thrombotic events

Protein Resistances (Protein C, Protein S)

PE, DVT, other thrombotic events

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Clinical relevance of coagulation testing (II/II)

Manifestation Overdosage can cause severe bleeding Superficial bruises, continuous bleedings Regular bleeding incidents

Tendency to BLEED Anticoagulant Therapy (PT-INR, aPTT, anti-Xa) Haemophilia (Factor VIII, IX) Factor Deficiencies (Factor II, Factor XIII) Von Willebrandt Factor (Dysfunction) (vWF)

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An introduction to D-Dimer

The ideal activation marker Why test D-Dimer ƒ D-Dimer allows doctors to find out whether the coagulation system has been activated ƒ D-Dimer testing is robust, rapid, accurate and of proven clinical utility Benefits with D-Dimer testing ƒ ƒ ƒ ƒ

utility has been demonstrated in clinical studies does not require any special anticoagulants or sampling technique is insensitive to imperfections in drawing the blood is present in a sufficiently high concentration so that it can be measured quickly and accurately


D-Dimer in the coagulation cascade INTRINSIC

EXTRINSIC

unphysiological surfaces

lesion

contact activation platelet aggregation (collagen, cell fragments, glas) Thrombin XII XIIa XI

Tissue factor (TF) TFPI VIIa

VII

XIa IX

VIII Prot. Ca/Prot. S

Ca2+ / PL

Ca2+ IXa

IX

VIIIa

Ca2+ / PL AT III

X

Xa Va

V

Ca2+ / PL X

Ca2+ / PL AT III

Prot. Ca/Prot. S

XIII Ca2+

Thrombin

Prothrombin

AT III Fibrinogen

XIIIa

B A Fibrinopeptides

Fibrin degradation products

Fibrini

Fibrins Ca2+

Plasminogen

TAFIa

D-dimer

Plasmin

Plasminogenactivator

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Haemostasis - D-Dimer

Step 1

Thrombin converts fibrinogen to soluble fibrin by cleaving the fibrinopeptides A and B. The fibrin monomers polymerize spontaneously.

Step 2

Active factor XIII links two Ddomains and generates a solid fibrin clot. D-Dimer is produced.

Step 3

Thus, fragments containing DDimer are formed during the degradation of the fibrin clot by plasmin.

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D-Dimer in clincal practice Thromboembolism is wide-spread and potentially fatal 1) Used in exclusion of venous thromboembolism (VTE) for two patterns: •

Deep Venous Thrombosis (DVT)

Pulmonary Embolism (PE)

Major predispositions are: •

immobilization

post-surgery (orthopedic +++)

cancers

inflammation

obesity

prothrombotic states

2) Used for diagnosis of disseminated intravasal disease (DIC) Data f

rom

423

labs in

Germ a ny

Spannagl M. et al. The performance of quantitative D-dimer assays in laboratory routine. Blood Coag Fibrinol 2005;18:439-443.

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D-Dimer in clincal practice

Diagnosing DVT and PE Diagnosis But

Expensive diagnostics methods (imaging) If D-dimer is negative the likelihood that the coagulation system has been activated is small

Highly probable that there is no DVT or PE Combinig D-dimer with a clinical decision rule 2nd criterion Clinical probability Recent studies

To minimize the risk that a patient with a thrombosis is excluded on the basis of a negative D-Dimer result Expressed as low/medium/high (Wells score) Æ Slide ruler as support Exclusion of DVT/PE only if D-dimer negative and cinicla probability low or medium 11


Venous Thromboembolism (VTE) – a severe disease

Its complication pulmonary embolism – a life threatening event

100 %

DVT Pulmonary Embolism – a potentially fatal complication

90

Survival

ca. 500,000 annual deaths from PE occur in the EU 80

ca. 26% of undiagnosed and untreated patients with PE suffer from subsequent fatal embolic events

70

another 26% will suffer from a nonfatal recurrent embolic event that can eventually be fatal

60

PE

50 1

Days

7

14

30 Heit et al. Thromb Haemost 2001; 86:452-63 12


D-Dimer in clincal practice

Recurrent VTE

他 A negative D-dimer test can exclude recurrent DVT (Adam, Blood 2008). 他 Diagnosis of abnormal D-dimer levels 1 month after cessation of oral anticoagulation is a positive predictor for therapy continuation after a 3 month oral anticoagulation therapy (n = 608). 他 In the group with abnormal D-Dimer levels and therapy discontinuation incidence of recurrent VTE was 15% compared to 2.9% in the group with therapy continuation (Legnani 2008).

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D-Dimer in clincal practice

Excluding VTE in pregnancy

他 In normal pregnancy D-dimer levels steadily increase until the time of delivery. 他 In a prospective study it was shown that D-dimer measurements are helpful to exclude DVT in the first two trimesters of pregnancy, while its value in the diagnosis of PE was limited (Chan 2007). 他 In general it is recommended to perform a D-dimer test together with a proper clinical assessment for suspected VTE in pregnancy. If the D-dimer test is positive radiological assessment should be performed (Stein 2006).

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Excellent STA Liatest D-Dimer performance

Engelhardt et al. Comparative evaluation of D-dimer assays for exclusion of deep venous thrombosis in symptomatic outpatients. Thrombosis Research 2003;112:25– 32

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D-Dimer testing on STA – best in class

STA Liatest D-Dimer: Ease-of-use and convenience Validation STA Liatest D-Dimer clinically validated for DVT/PE exclusion (n>5000, NPV>95%) Long onboard stability Use STA-Liatest with as little as 2-3 tests per day – convenience Fast time to result TAT < 10 minutes – fast time to result Pre-calibrated and ready-to-use reagent Ease of use, cost reduction STA Liatest D-Dimer is the best test for emergency and ICU testing 16


Clinical relevance of coagulation testing

Manifestation Overdosage can cause severe bleeding Superficial bruises, continuous bleedings Regular bleeding incidents

Tendency to BLEED Anticoagulant Therapy (PT-INR, aPTT, anti-Xa) Haemophilia (Factor VIII, IX) Factor Deficiencies (Factor II, Factor XIII) Von Willebrandt Factor (Dysfunction) (vWF)

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Incidende

Anticoagulation â&#x20AC;&#x201C; A balance

Thrombosi s

Safe area

Bleeding

Anticoagulant concentration

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Anticoagulation

The ideal anticoagulant Anticoagulant

• Predictable dose response without diagnostics monitoring • Administration by parenteral and oral routes (inpatient/ambulant) • Quick and high bioavailability • Availability of safe antidote • Freedom from side effects • Minimal interaction (with food or other drugs) • Low rate of bleeding events Hirsh et al. Blood 2005, 105:453-463

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Points of application of anticoagulation

(e.g. Marcumar)

(e.g. Rivaroxaban)

(e.g. Fondaparinux) Heparins

(e.g. Dabigatran

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Marcumar

Mechanism of action and indication » Vitamin K is essential for the hepatic synthesis of clotting factors II (prothrombin), VII, IX, and X as well as anticoagulant protein C and S. VKAs inhibit the synthesis of the biologically active forms. » Differences in factor reaction (half-life) Æ Factor VII (6h), Protein C (7h), Factor II (70h) » Stable anticoagulation only after 3-4 days

VK-O

VK-H2

Thomas L. Labor und Diagnose, Chapter 16, 7. 2008, TH books Frankfurt

Indications - Treatment and secondary prevention of VTE - Long term prophylaxis/anticoagulation of embolic stroke in patients with artrial fibrillation - Prophylaxis in patients after valve replacement 21


Marcumar

Monitoring: Yes or no? If yes, how? ¾ Monitoring? Æ Yes

¾ Monitoring how? Æ INR = Internationalized ratio of PT prolongation Pay attention „INR can only be used in the stable phase of oral anticoagulantion therapy and not at start of therapy or for routine screening.“ Barthels M., von Depka M.: Das Gerinnungskompendium, Thieme Verlag 2003, S. 321

Importance of continuous monitoring : - Recommended therapeutic INR ranges: 2.0 to 3.0 for most conditions - The risk of bleeding doubles with each one-point increase in INR outside the therapeutic range Æ continuous monitoring should be ensured when starting VKA therapy, changing the dose and when there are dietary modifications or other medications known to interact

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Heparins

Mechanism of action » indirect » enhancement/ acceleration of antithrombin action by binding to it … » inactivation of several coagulation enzymes, including factors IIa (thrombin), Xa, IXa, XIa, and XIIa. Thrombin and factor Xa are most reactive to inhibition Indications V

+

Xa

IIa

Anticoagulation esp. of in-patients Antithrombin

– prophylaxis of thrombosis - thrombosis therapy Selected treatment of out patients - pregnant women

Fib

Short term anticoagulation 23


Heparins UFH monitoring: yes or no? If yes, how? Monitoring?

Unfractionated Heparins (UFH) â&#x20AC;˘ polysaccharide chains with molecular weights ranging from 5000 to 30000 kDa - Anti-Xa/Anti-II = 1:1 - Short half-life

NO Prophylactic dosage1)

Yes Therapeutical dosage

- Only 30 to 70% bio-availability - Unpredictable dosing - Antidote available (protamin) - Large variation in individually response

aPTT

anti Xa activity

- Risk of bleeding episodes (major bleedings in 0.8% of patients receiving full-dose UFH) - Risk of Heparin induced thrombocytopenia (HIT)

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UFH monitoring

aPTT Therapeutic range:

- Cheap

1,5 – 2,5 times the control value

- Extensive experience - Global indication of the patient's coagulation situation - No standardized method - Variances between reagent sensitivity and lots

Basu D et al. A prospective study of the value of monitoring heparin treatment with the activated partial thromboplastin time. N Engl J Med 1972; 287:324-7

Multiple influencing factors next to heparin (factors, preanlaytic steps…) Æ e.g. FVIII and fibrinogen elevation can shorten the aPTT significantly (pregnancy) leading to an underestimation of the heparinization level

1) Baglin T et al.: Guidelines on the use and monitoring of heparin. British Society for Haematology 2006;133: 19–34

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UFH monitoring

Anti-Xa-activity (Therapeutical range) Target range:

When to use which test?

0,3 – 0,7 IU/ml1,2)

aPTT: all patients (with therapeutical dosage)

Calibrated and standardized parameter Only level of heparin is measured

Important: Calibrator for UFH to be used with the anti-Xa activity test

anti-Xa activity additionally… - when aPTT is not prolonged adequately in relation to injected amount of heparin (heparin resistance?)

- when aPTT is signficantly prolonged with a small amount of heparin (can Antithrombotic Therapy for Venous Thromboembolic Disease: The Seventh ACCPonly Conference on heparin be the cause?)

1) Büller et al. Antithrombotic andThrombolytic Therapy. Chest 2004;126;401-428 2) Hirsh J and Raschke R Heparin and Low-Molecular-Weight Heparin: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126;188-203

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Low Molecular Weight Heparins (LMWH) “The younger brother” Shorter chains and lower molecular weight (~4 kD) than UFH Anti-Xa : Anti-IIa = 2,5-4 : 1 depending on mol. size distribution

-

Reduced incidence of bleeding complications (ca. 4%)*

-

Bio-availability 100% Æ standard dosages possible

-

Longer activity: Half-life 2 to 4 times longer than UFH

- Reduced incidence of HIT type II (Indidence ca. 0,1%) - Antidote: only partially with protamin (50%) Harenberg J und Fenyvesi T Heparine, Thrombin- und Faktor-Xa-Inhibitoren. Hämostaseologie 2004;24:261–78

LMWHs have gradually substituted UFH for most indications * Thomas L. Labor und Diagnose, Kapitel 16, 7. Auflage 2008, TH books Frankfurt

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LMWH

Monitoring: Yes or no? » No general monitoring

Peak 3-4 h after sc.-injection

» ONLY for … » Patients with renal insufficiency1) » Patients with over- underweight1) » Pregnant1) » Children1) » Neonates 2)

1) Harenberg J. Is laboratory monitoring of low-molecular-weight heparin therapy necessary? Yes. J Thromb Haemost 2004;2: 547–50. 2) Harenberg J und Fenyvesi T Heparine, Thrombin- und Faktor-Xa-Inhibitoren. Hämostaseologie 2004;24:261–78

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LMWH

Monitoring: How? » PTT? Æ No …, as there is no direct connection between LMWH level and PTT » Anti-Xa-activity? Æ Yes …, as LMWH level is determined by aXa-activity » Important notes: • Samples should be acquired 4 hours after subcutaneous injection Æ peak • Target concentration for peak level depends on the daily dose (one or two doses) • Calibration with dedication calibrator (LMWH calibrator) necessary

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LMWH

Monitoring: anti-Xa-activity Æ target ranges LMWH [IU/ml] Literature

Prophylaxis

Therapy venous thrombosis 1x daily

Therapy venous thrombosis 2x daily

> 1,0 Enoxaparin 0,85 Tinzaparin

1,2

1,3 Nadroparin

0,6 - 1,0 Enoxaparin Nadroparin

1,05 Dalteparin 3

0,1 – 0,4

4 5

0,1 – 0,2

7 0,1 – 0,4

0,4 – 1,1 1,0 – 2,0

0,6 – 1,0

1,0 – 2,0

0,4 – 1,1

0,8 - 1,6

0,5–1,1 1,0 – 1,6 (2,0)

0,4 – 1,1

1) Büller et al.: Antithrombotic Therapy for Venous Thromboembolic Disease: The Seventh ACCP Conference on Antithrombotic andThrombolytic Therapy. Chest 2004;126;401-428 2) Hirsh J, Raschke R: Heparin and Low-Molecular-Weight Heparin: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126;188-203 3) Fachinformation Clexane® 60/80/100 mg (Enoxaparin) August 2007 sanofi aventis 4) S2 Leitlinie Bein- und Beckenvenenthrombose (TVT); VASA 2005;34:Suppl.66 5) Haas S.: Niedermolekulare Heparine, Kap V, S. 155, Springer Verlag Heidelberg 2006 6) Harenberg J.: Is laboratory monitoring of low-molecular-weight heparin therapy necessary? Yes. J Thromb Haemost 2004;2: 547–50.

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Fondaparinux (ArixtraÂŽ)

Indirect factor Xa-inhibitor = synthetic analog of a pentasaccharide sequence (5 monosaccharids) Âť enhances (accelerates) the antithrombin action times 300 with acceleration of factor Xa inactivation (no thrombin inactivation)

Indications V

+

Xa

IIa

Fib

Antithrombin

2001: patients undergoing high risk surgery (major orthopedic surgery) 2004: therapy and prophylaxis for DVT and PE Only recently efficacy and safety was proven for ACS

31


Fondaparinux (Arixtra®)

Advantages- and drawbacks » High bioavailability (almost 100%) => standard dosages possible (prophylaxis: 2,5 mg/d; therapy: 7,5 mg/d) » Long effect (half life ca. 15h) => only 1 sc.- injection per day necessary => more difficult steering compared to LMWH » NO antagonist available » Bleeding risk comparable to LMWHs » Only parenteral » Antithrombin-“dependent“ (activity > 50%) » It is excreted unchanged in urine Æ A cumulation risk exists in patients with renal insufficiency.

32


Fondaparinux (Arixtra®)

Monitoring: Yes or no? » No general monitoring » But: „Monitoring might be recommended“ in case of1)… » Renal impairment (Crea Clearance 20 – 50 ml/min) » Elderly patients and body weight < 50 kg » PTT? Æ No as dedicted aXa inhibitors have no influence on aPTT

aXa-activity? Æ Yes as Fondaparinux effect can only determined with aXa activity

Important notes Samples should be acquired 3-4 hours after subcutaneous injection Æ peak Calibration with dedicated calibrator (Fondaparinux calibrator) necessary 1) Fachinformation Arixtra ® 2,5 mg/ 0,5 ml (Fondaparinux) Oktober 2007 GlaxoSmithKline

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Line of heparin assays with dedicated calibrators

It´s your choice Monitoring

UFH or LMWH

Reagents

STA®-Rotachrom® Heparin 4mL & 8mL

Type of calibration

Working range

Dedicated calibrations UFH or LMWH 0.1-0.7 UI

0.1-2 UI/mL

anti-Xa/mL The laboratory is frequently challenged by®-Hepanorm finding out® which Calibrators STA H STA ®4 x 3 has X 1 mL Calibrator anticoagulant been prescribed: UFH or LMWH? HBPM

4 x 3 x 1 mL Quality Support for the laboratoryControl with the controls unique and single hybrid curve and / or STA®-Heparin

calibration UFH-LMWH to monitor 6 x 2 x 1 mL the anti-Xa activity of both types of heparin

Fondaparinux

Hybrid

Dedicated

calibration

calibration

UFH & LMWH

Fondaparinux

UFH : 0.1-1 UI/mL

0.1-2 μg/mL

LMWH : 0.1-2 UI/mL ®-Hybrid Hep STA Calibrator 4 x 5 x 1 mL STA®-Quality HBPM

STA®-Fondaparinux Calibrator 2 x 3 x 1 mL STA®-Fondaparinux Control

6 x 2 x 1 mL

3 x 2 x 1 mL 34


Passion for Coagulation

Helping to improve patient care and diagnostic efficien

Laboratory Automation

Routine- & Special Testing

Self- and Professional Monitoring

Laboratory and diagnostic efficiency


Point-of-Care coagulation monitoring

Patient and professional solution for INR monitoring CoaguChek® XS • Simple and fast results help increase patient comfort • Unique measurement principle helps ensure high quality results • Built-in system control provides high level of safety

CoaguChek® XS Plus – The professional solution • High quality results, correlating very well to laboratory method • Increased safety features for professional use: optional quality control (QC) lockout and operator lockout • Connectivity to computer and network

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Passion for Coagulation

Helping to improve patient care and diagnostic efficien

Laboratory Automation

Routine- & Special Testing

Self- and Professional Monitoring

Laboratory and diagnostic efficiency


Reliable and robust genetical screening

The LightCycler速 2.0 instrument Rapid-cycle PCR combined with real-time fluorescence monitoring The components of the kits are designed to maximize test performance with minimal handling steps Fast, reliable results Highly sensitive and accurate in vitro diagnostic tests: Analytical sensitivity: 198 copies (Factor II); 202 copies (Factor V). Accuracy: 98.9% (Factor II); 99.4 (Factor V) Fully validated tests Use the first CE-marked and FDA-cleared DNA-based test to analyze the two most common genetic risk factors for thrombotic events 38


For reliable analyses in daily routine

STA Compact benchtop analyzer Sample management

Cap piercing & cuvettes

96 positions with barcode identification

Optional routine cap piercing for broad range of tubes

Reagent management

Measurement principle

45 cooled positions for random loading

Simultaneous measurement of clotting, chromogenic and immunological assays

Reagent menu

Software

Complete routine & special reagent menu

Comprehensive software connectable to LIS 39


High quality high throughput testing

STA R Evolution Sample management

Cap piercing & cuvettes

220 positions with continuous loading & barcode identification

Optional routine cap piercing for broad range of tubes

Reagent management

Measurement principle

70 cooled positions for random loading

Simultaneous measurement of clotting, chromogenic and immunological assays

Reagent menu Widest menu of assays for haemostasis with complete management of reagents

Intuitive software enhances userfriendliness Easy-to-use Windows XP operator interface connectable to LIS 40


Reliable routine- & special testing for central laboratories

The STA system family and STA concept Barcoded and precalibrated reagents reduce hands-on time Basic reagent information (lot, volume, etc.) is transferred into the systems via barcode Most relevant routine tests are pre-calibrated STA Neoplastin (R) STA Fibrinogen

STA LIATEST Protein S free STA LIATEST D-Dimer

Thousands of installations ensure proven laboratory performance 5000 installations throughout the world make the STA速 system family a reliable partner in daily laboratory work. 41


Reliable routine- & special testing for central laboratories

The STA system family and STA concept Cap-piercing in routine enhances laboratory safety The STA速 systems offer an optional cap-piercing functionality providing reliable protection from hazardous patient samples.

STA concept: interchangeable reagents and consumables for flexible utilization Both instruments utilize the same materials (reagents, cuvettes, consumables etc.). This facilitates logistical procedures and contributes to efficiency gains. 42


STA technology you can rely on

Chromogenic and immunological testing

Technology

Photometer with 405 and 540 nm for chromogenic tests and immuno-assays

â&#x20AC;˘ 405 nm

- AT III - Protein C chromogen - Heparin (anti Xa) - Plasminogen & Antiplasmin

â&#x20AC;˘ 540 nm

- vWF - Protein S free - D-Dimer

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Best results for clotting tests with the Stago patented viscosity based detection system (VBDS) Technology:

VBDS (Viscosity Based Detection System) for clotting tests

Insensitive to:

Coloured plasmas Haemolysed plasmas Lipaemic plasmas Bilirubin Turbid reagents

Maximum sensitivity for: Weak clots e.g. Fibrinogen testing linearity 1.5 to 9 g/l (automatic re dilution) All clotting tests Standardisation: For each clotting process For all STA analyzers 44


The detection is based on the increase of viscosity of the plasma being tested. Increase of viscosity is measured through the motion of a steel ball.

45


The ball motion is activated by 2 coils, working alternatively to maintain a natural oscillation.

Activating coil

Activating coil

46


When the start reagent is added, the detection starts immediately 47


When the ball starts oscillating left and right the chronometer starts. The amplitude of the ball is measured. 48


Amplitude is monitored during the entire clotting process Amplitude remains constant while no clot is present

49


As the clot appears, the viscosity increases, and the amplitude decreases.

50


Based on different algorithms, the chronometer is stopped even if the clot is weak, and even if the ball is not stopped.

51


Superior Fibrinogen results with the STA concept Example: External Quality Survey Belgium

18 16 14 12 10 8 6 4 2 0

Fibrinogen no. 1 Fibrinogen no. 2 Fibrinogen no. 3

Optical methods

Fibrinogen no. 4

CO/6297 6914 6915 CO/7057 7058 7059 CO/7395 7398 7399 7400 CO/7113 7145 7564 CO/7163 7768 7815 CO/7688 7884 8144

CV %

Precision Monitoring Fibrinogen IHE 2006&2007

Sample

Roche STA Fibrinogen

Viscosity based detection

52


National Committee for Clinical Laboratory Standards: no interferences with mechanical detection systems Recommendation by NCCLS:

53


Passion for Coagulation

Helping to improve patient care and diagnostic efficien

Laboratory Automation

Routine- & Special Testing

Self- and Professional Monitoring

Laboratory and diagnostic efficiency


Degree of automation

From consolidation to total lab automation

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Total laboratory automation

Revolutionizes your laboratory processes More than 33 sites worldwide with STA R Evolution connected to MPA MODULAR PRE-ANALYTICS connected to cobas 6000 analyzer series and STA R • Reference Evolution sites: Klinikum Fulda, Germany and Clinique St. Luc, Bougé, Belgium TLA highlights • Automated pre-sorting of samples • Automation of centrifugation, decapping • Automated archiving • Automated sample transportation to SWA instruments and STA R Evolution • Continuous sample processing with defined TAT • Parallel processing of CC/HIA, HetIA and coag • Reduces exposure to hazardous biological samples

56


Passion for Coagulation with Roche Diagnostics

Your reliable partner for all coagulation needs

Self- and Professional Monitoring

Routine- & Special Testing

Laboratory Automation

57


Same high quality standards for all STA system reagents Routine tests Test PT

STA Neoplastin Plus * STA Neoplastin R * STA Hepato Quick * STA APTT STA APTT Kaolin STA Cephascreen STA Fibrinogen (Clauss) * STA Thrombin STA Reptilase

PTT

Fibrinogen

Risk for thrombosis Test AT III Protein C

STA Antithrombin III STA Protein C Clotting STA Protein C chromogen STA Protein S Clotting STA LIATEST Free Protein S* STA dRVVT screen/confirm

Protein S Lupus

Activation of coagulation Test D-Dimer

STA LIATEST D-DI *

OAT with LMWH Test Heparin

STA Rotachrom Heparin

Fibrinolysis Test Antiplasmin Plasminogen

STA Antiplasmin STA Plasminogen

Bleeding risk/ Factors Test von Willebrand Fact. Factor II Factor V Factor VII Factor VIII Factor IX Factor X Factor XI Factor XII

STA LIATEST vWF STA Factor II STA Factor V STA Factor VII STA Factor VIII STA Factor IX STA Factor X STA Factor XI STA Factor XII

* Precalibrated reagent 58


The largest portfolio for research and specialty testing Special reagents (CE) • • • • • • • • • • • • • • • • • •

• • • • • • • • Asserachrom HPIA • • Staclot LA • PTT LA • Asserachrom APA screen Asserachrom Anti-Prothrombin IgG, M • • Asserachrom D-Di • Asserachrom IX:Ag • Asserachrom PF4 • Asserachrom b-TG • Asserachrom tPA • Asserachrom vWF • Asserachrom CB (Q2, 07) Asserachrom Protein C Asserachrom Free Protein S Asserachrom Total Protein S STA LIATEST Free Protein S Liatest Protein S Liatest AT III

Staclot VIIa-rTF Stachrom HCII (Heparin Cofactor II) Stachrom PAI Asserachrom PAI 1 Asserachrom Free TFPI Asserachrom Total TFPI Asserachrom VII:Ag Asserachrom X:Ag Asserachrom sEPCR Asserachrom VIIC:Ag Asserachrom PIVKA-II Asserachrom Thrombomodulin Asserachrom Protein Z Asserachrom Soluble GPVAsserachrom TAFI Asserachrom Anti ß2GP1 IgG Asserachrom Anti-ß2GP1 IgM Liatest ß2-GlycoProtein I Liatest C4b-BP STA Liatest FM STA Stachrom TAFI 59


Thank you for your attention

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