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cobas h 232 system

When on the spot cardiac decisions need on the spot results in Primary Care

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Is there a better pathway?


Without Point of Care (POC) testing
Patient presents

Blood sample taken

Lab collects sample (daily collection)

Sample prepared and analysed in the lab

Result generated (electronic or hard copy)

Result communicated to patient

Appropriate action taken

With POC testing


Patient presents

POC test in only 12 minutes

POC test gives on the spot result

Appropriate action taken

The path of least resistance


By providing rapid, accurate results near the patient, POC testing speeds up diagnosis and treatment, improving clinical outcomes and ensuring patients are managed efficiently and more cost-effectively.

Practices should put in place models of care so that they use a systematic approach foridentifying people at high risk of CHD(and) offering regular review to people at high risk of CHD.
National Service Framework Coronary Heart Disease

Practice management
Results are available within minutes, helping to improve efficiency Appropriate treatment can be given without delay Hospital referrals can be reserved for patients who really need it 13

Patient outcomes
Rapid diagnosis allows appropriate treatment to be initiated by GPs Early diagnosis and treatment reassures patients and reduces anxiety associated with uncertainty

Cost-effectiveness
Early therapeutic initiation and regular monitoring can help reduce complications and improve cost-efficiency 4 Avoiding unnecessary referrals to Secondary Care will save the practice money

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Introducing the new cobas h 232 system


Designed for on the spot cardiac decisions
Speed
Results available in 8 12 minutes Rapid, on-the-spot decision support for treatment, referral, or discharge of cardiovascular patients

Portability
Portable device which is suitable for use in the GPs surgery, one stop clinics or community hospitals

Ease of use
Insert strip, apply sample, read result Intuitive touch-screen No maintenance Easy to clean

Reliability
On board QC External QC through the provision of EQA ampoules Results comparable to Roche laboratory methods 58 Quality assurance via patient identification and QC operator lock-out

Connectivity
Results transmitted via IR to printer or Base Unit In combination with cobas IT 1000 data management solution, reduces effort for documentation and fulfilment of quality assurance requirements

cobas h 232 when you need to be sure


3 simple steps to quick results

Slide in test strip

Apply sample (150 L heparinized whole blood)

Result appears on screen within minutes

Test Strip & Material Order No. Roche CARDIAC D-Dimer 04877802 190

Parameter

Reaction Time

Measuring Range

Clinical Utility

Cut-off

D-dimer

8 mins

0.14.0 g/mL

Exclusion of deep vein thrombosis and pulmonary embolism

0.5 g/mL

Roche CARDIAC proBNP 04877845 190

NT-proBNP

12 mins

603000 pg/mL

Diagnosis and assessment of congestive heart failure Risk stratification in acute coronary syndrome

Exclusion of non-acute heart failure < 125 pg/mL Exclusion of acute heart failure < 300 pg/mL Consideration of age-stratified cut-points for diagnosis (= CHF likely considering confounding factors) Patient age < 50 50-75 > 75 NT-proBNP value > 450 pg/mL > 900 pg/mL > 1800 pg/mL

Roche CARDIAC T Quantitative 04877772 190

Troponin T

12 mins

0.032 ng/mL (quantitative range 0.12 ng/mL)

Diagnosis of acute coronary syndrome and myocardial infarction

< 0.03 ng/mL low risk 0.030.1 ng/mL medium risk > 0.1 ng/mL high risk

Roche CARDIAC M** 04877799 190

Myoglobin

8 mins

30700 ng/mL

Early marker of myocardial damage to assist in diagnosis of acute coronary syndrome and myocardial infarction Diagnosis of acute coronary syndrome and myocardial infarction, assessment of re-infarction

70 ng/mL

Roche CARDIAC CK-MB 04877900 190

CK-MB

12 mins

1.040 ng/mL

Female: 4 ng/mL* Male: 7 ng/mL*

* At the 99th percentile of a reference population ** Roche CARDIAC M for use on the cobas h 232 system will be available in the course of Q3/2007

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D-dimer
D-dimer is a specific fragment of cross-linked fibrin that circulates in the blood stream for several days following a thrombotic event, such as DVT. Patients at high risk of DVT include those receiving high dose oestrogen therapy, those who have previous history of DVT, post surgical and limited mobility.9 D-dimer is produced naturally as part of the wound healing process, but can be found in higher quantities in the blood in abnormal clotting processes, as with thrombosis or embolism. When clots are formed at the wrong time and place as a result of underlying diseases, the presence of D-dimer indicates the occurrence of unwanted thrombotic events.

Diagnostic value of D-dimer:


D-dimer is a valuable marker to rule out suspected DVT and PE 10,11 Used as first diagnostic step, the determination of D-dimer helps to avoid unnecessary and expensive examinations and therapeutic interventions D-dimer based protocols can reduce treatment costs by avoiding the use of expensive imaging techniques 12

NT-proBNP
BNP is synthesized as the prohormone proBNP and is released from the myocardium into the circulation upon myocardial stress. After stimulation of heart muscle cells, proBNP is cleaved by a protease into N-terminal proBNP (NT-proBNP) and the biologically active hormone BNP. The biological half-life of NT-proBNP is 60 120 minutes (BNP is only 20 minutes).

Diagnostic value of NT-proBNP:


High negative predictive value ( > 97%) enables exclusion of heart failure in symptomatic patients, allowing appropriate action to be taken 13 Helps to confirm the presence of heart failure, giving confidence to begin appropriate treatment sooner An alternative assessment to Echo, reducing pressure on waiting lists 14,15 Sensitive test enables diagnosis of systolic and diastolic ventricular dysfunction, even in mild and asymptomatic cases of heart failure 16 Allows for risk stratification and assessment of prognosis across a wide range of cardiovascular diseases 17 Cost savings by optimising resources 18 and decreasing the need for other diagnostic tests 19

Diagnostic value of NT-proBNP:


250 Pre NT-proBNP Post NT-proBNP

200

% reduction

150

100

50

0
ECHO referral Card OP referral Med Op referral Start anti-HF tt

60%

44%

76%

76%
Adapted from reference 20

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Troponin T
Cardiac troponin T is the most specific, and sensitive, biochemical marker of myocardial necrosis. A positive test result clearly establishes the diagnosis of myocardial infarction, even if symptoms or electrographic changes are ambiguous or not present.

Diagnostic value of troponin T:


Most appropriate cardiac marker and criterion to define acute myocardial infarction, according to the ESC/ACC recommendations 21,22 Can detect non-ST segment infarctions in patients presenting with acute coronary syndrome Large window of detection (2 hours up to 14 days) an infarction can be confirmed in patients that report complaints only, after one or two weeks

Myoglobin
Myoglobin, a non cardiac specific protein in the cytoplasm of striated muscles, is rapidly released from the cells after muscle damage. Determination of myoglobin covers the early phase of myocardial infarction diagnosis since it is the first and the most sensitive biochemical marker that can be detected in the blood. Myoglobin increases as early as 1 to 2 hours after the onset of chest pain. However, since elevated myoglobin is not specific for damage of the heart muscle, a troponin T test must be performed to confirm the diagnosis of myocardial infarction. Myocardial infarction is ruled out if myoglobin is not detected within 6 hours after onset of symptoms.23

Diagnostic value of myoglobin:


Earliest marker to appear < 2 hours post-infarction Useful when the patient presents to physician very soon after onset of symptoms 24

CK-MB
Creatine kinase (CK) is an enzyme that mainly occurs in muscles, heart and brain. It is divided into three different forms: CK-MM (muscle type), CK-MB (heart-type) and CK-BB (brain-type). Total CK thus only offers limited specificity. In myocardial damage, such as in acute myocardial infarction, cardiac specific CK-MB is released from destroyed myocardial cells. An increase of CK-MB activity in the blood can be detected as early as 23 hours after the infarction. CK-MB activity reaches its peak after 1224 hours and returns to the reference range usually after 23 days.

Diagnostic value of CK-MB:


Diagnosis of ACS and myocardial infarction CK-MB and troponin T have identical intended uses except that, due to the different kinetics with a shorter half-life (peak within 24 hours), CK-MB can be used for reinfarction assessment CK-MB is indicative for reinfarction if level does not return to normal within approx. 23 days from peak, whereas troponin T is still elevated 1 Can be used in combination with myoglobin and troponin T for a complete assessment of cardiac markers to allow alignment with existing protocols when specifically indicated by the patient's circumstances

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Useful information
Websites
NICE National Institute for Clinical Excellence http://www.nice.org.uk/ SIGN Scottish Intercollegiate Guidelines Network http://www.sign.ac.uk/ DoH Publications and Statistics http://www.dh.gov.uk/PublicationsAndStatistics/Publications/Publications PolicyAndGuidance/DH 4094275 Cardiology Pathway http://www.18weeks.nhs.uk/public/ Practice Based Commissioning http://www.dh.gov.uk/assetRoot/04/13/13/97/04131397.pdf Health Improvement Programme http://www.heart.nhs.uk/Health Improvement Programme

Material order numbers:


Material Order No. Roche CARDIAC IQC strip Reusable control strips to verify the function of the cobas h 232 analyzer Dosing device for sample transfer from primary sampling tube. Labelled to showrequired sample volume Battery pack recharging Data interface Connectivity: USB and Ethernet port Interface to cobas IT 1000 data management solution POCT1A protocol for interfacing to cobas IT 1000 data management solution or third party systems as well as LIS/HIS Handheld Battery Pack Rechargable battery pack for up to 10 measurements 04805640 001 04880668 190

Roche CARDIAC Pipettes

11622889 190

Handheld Base Unit/ Connectivity Interfaces

04805658 001

IT Data Management

References
1. Wu A, et al. National Academy of Clinical Biochemistry Standards of Laboratory Practice: Recommendations for the Use of Cardiac Markers in Coronary Artery Diseases. Clin Chem 1999; 45: 11041121. 2. Oudega R, Moons KG, Hoes AW. Ruling out deep venous thrombosis in primary care. A simple diagnostic algorithm including D-dimer testing. Thromb Haemost 2005; 94: 200 205. 3. Campbell PM, Radensky PW, Denham CR. Economic analysis of systematic anticoagulation management vs. routine medical care for patients on oral warfarin therapy. Dis Manag Clin Outcomes 2000; 2: 18. 4. Horstkotte D, Piper C, Wiemer M. Optimal Frequency of Patient Monitoring and Intensity of Oral Anticoagulation Therapy in Valvular Heart Disease. J Thromb Thrombolysis 1998; 5 Suppl 1: 19 24. 5. Zugck C et al. Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood. Clin Chem Lab Med 2006; 44(10): 1269 1277. 6. Dempfle CE et al on behalf of the CARDIM study group. Sensitivity and specificity of a quantitative point of care D-dimer assay using heparinised whole blood, in patients with clinically suspected deep vein thrombosis. Thromb Haemost 2006; 95: 79 83. 7. Derhaschnig U et al for the CARMYT Multicentre Study Group. Diagnostic efficiency of a point-of-care system for quantitative determination of troponin T and myoglobin in the coronary care unit. Point of Care 2004; 3(4): 162164.

8. Schwab M et al. "Evaluation Report: System Performance of the cobas h 232 system" (www.roche.com/cobas-h232.html]. 9. Thromboembolic Risk Factors (THRIFT) Consensus Group. Risk of and prophylaxis for venous thromboembolism in hospital patients. BMJ 1992; 305: 567 574. 10. Brown M, et al. An emergency department guideline for the diagnosis of pulmonary embolism: an outcome study. Acad Emerg Med 2005; 12: 20 25. 11. Diamond S, et al. Use of D-dimer to aid in excluding deep venous thrombosis in ambulatory patients. Am J Surg 2005; 189: 23 26. 12. Perrier A, et al. Cost-effectiveness analysis of diagnostic strategies for suspected pulmonary embolism including helical computed tomography. Am J Respir Crit Care Med 2003; 167: 39 44. 13. Hobbs FO, et al. Reliability of N-terminal pro-brain natriuretic peptide assay in diagnosis of heart failure: cohort study in representative and high risk community populations. BMJ 2002; 324: 1498. 14. Quality and Outcomes Framework (QOF). http://www.dh.gov.uk/assetRoot/04/07/86/59/04078659.pdf 15. SIGN. Scottish Intercollegiate Guidelines Network. http://www.sign.ac.uk/guidelines/published/index.html 16. Hobbs FO, et al. Reliability of N-terminal proBNP assay in diagnosis of left ventricular systolic dysfunction within representative and high risk populations. Heart 2004; 90: 866 870. 17. Mockel M, et al. Role of N-terminal pro-B-type natriuretic peptide in risk stratification in patients presenting in the emergency room. Clin Chem 2005; 51: 1624 1631. 18. Siebert U, et al. Cost-effectiveness of using N-terminal pro-brain natriuretic peptide to guide the diagnostic assessment and management of dyspneic patients in the emergency department. Am J Cardiol 2006; 98: 800 805. 19. Nielsen LS, et al. N-terminal pro-brain natriuretic peptide for discriminating between cardiac and non cardiac dyspnea. Eur J Heart Fail 2004; 6: 63 70. 20. BNP Experience in southern Derbyshire, Martin Cassidy. http://www.tcn.nhs.uk/content/showcontent.aspx?contentid=884. 21. Alpert J, et al. Myocardial infarction redefined-a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol 2000; 36: 959 969. 22. Pollack C, et al. 2002 update to the ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: implications for emergency department practice. Ann Emerg Med 2003; 41: 355 369. 23. de Winter R, et al. Value of myoglobin, troponin T, and CK-MBmass in ruling out an acute myocardial infarction in the emergency room. Circulation 1995; 92: 3401 3407. 24. Mockel M, et al. Validation of NACB and IFCC guidelines for the use of cardiac markers for early diagnosis and risk assessment in patients with acute coronary syndromes. Clin Chim Acta 2001; 303: 167179.

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COBAS, LIFE NEEDS ANSWERS, COBAS H, ROCHE CARDIAC are trademarks of Roche. 2007 Roche Diagnostics Roche Diagnostics Limited Charles Avneue Burgess Hill, RH15 9RY www.cobas-roche.co.uk

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