cobas h 232 system When on the spot cardiac decisions need on the spot results in Primary Care cobas cardio

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1 cobas h 232 system When on the spot cardiac decisions need on the spot results in Primary Care

2 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

3 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 for identifying 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 1 3 Patient outcomes Rapid diagnosis allows appropriate treatment to be initiated by GP s 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

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

4 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 GP s 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 5 8 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 1 2 3 Slide in test strip Apply sample (150 µl heparinized whole blood) Result appears on screen within minutes Test Strip &

5 µg/ml 04877802 190 thrombosis and pulmonary embolism Roche CARDIAC probnp NT-proBNP 12 mins 60 3000 pg/ml Diagnosis and assessment Exclusion of non-acute 04877845 190 of congestive heart failure

considering confounding factors) Patient age NT-proBNP value < 50 > 450 pg/ml 50-75 > 900 pg/ml > 75 > 1800 pg/ml Roche CARDIAC T Quantitative Troponin T 12 mins 0.

5 cobas h 232 when you need to be sure 3 simple steps to quick results Slide in test strip Apply sample (150 µl heparinized whole blood) Result appears on screen within minutes Test Strip & Parameter Reaction Time Measuring Range Clinical Utility Cut-off Material Order No. Roche CARDIAC D-Dimer D-dimer 8 mins µg/ml Exclusion of deep vein 0.5 µg/ml thrombosis and pulmonary embolism Roche CARDIAC probnp NT-proBNP 12 mins pg/ml Diagnosis and assessment Exclusion of non-acute of congestive heart failure heart failure < 125 pg/ml Risk stratification in acute coronary syndrome Exclusion of acute heart failure < 300 pg/ml Consideration of age-stratified cut-points for diagnosis (= CHF likely considering confounding factors) Patient age NT-proBNP value < 50 > 450 pg/ml > 900 pg/ml > 75 > 1800 pg/ml Roche CARDIAC T Quantitative Troponin T 12 mins ng/ml Diagnosis of acute coronary < 0.03 ng/ml low risk (quantitative range syndrome and myocardial ng/ml medium risk ng/ml) infarction > 0.1 ng/ml high risk Roche CARDIAC M** Myoglobin 8 mins ng/ml Early marker of myocardial 70 ng/ml damage to assist in diagnosis of acute coronary syndrome and myocardial infarction Roche CARDIAC CK-MB CK-MB 12 mins ng/ml Diagnosis of acute coronary Female: syndrome and myocardial 4 ng/ml* infarction, assessment of Male: re-infarction 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

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.

6 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

7 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 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: Pre NT-proBNP Post NT-proBNP % reduction ECHO referral Card OP referral Med Op referral Start anti-hf tt 60% 44% 76% 76% Adapted from reference 20

8 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).

9 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 2 3 hours after the infarction. CK-MB activity reaches its peak after hours and returns to the reference range usually after 2 3 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. 2 3 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

10 Useful information Websites NICE National Institute for Clinical Excellence SIGN Scottish Intercollegiate Guidelines Network DoH Publications and Statistics PolicyAndGuidance/DH Cardiology Pathway Practice Based Commissioning Health Improvement Programme 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 Roche CARDIAC Pipettes Dosing device for sample transfer from primary sampling tube Labelled to showrequired sample volume Handheld Base Unit/ Battery pack recharging Connectivity Interfaces Data interface Connectivity: USB and Ethernet port IT Data Management 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

11 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: 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: 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: 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: 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): 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: 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): Schwab M et al. "Evaluation Report: System Performance of the cobas h 232 system" ( 9. Thromboembolic Risk Factors (THRIFT) Consensus Group. Risk of and prophylaxis for venous thromboembolism in hospital patients. BMJ 1992; 305: Brown M, et al. An emergency department guideline for the diagnosis of pulmonary embolism: an outcome study. Acad Emerg Med 2005; 12: Diamond S, et al. Use of D-dimer to aid in excluding deep venous thrombosis in ambulatory patients. Am J Surg 2005; 189: 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: 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: Quality and Outcomes Framework (QOF) SIGN. Scottish Intercollegiate Guidelines Network 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: 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: 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: Nielsen LS, et al. N-terminal pro-brain natriuretic peptide for discriminating between cardiac and non cardiac dyspnea. Eur J Heart Fail 2004; 6: BNP Experience in southern Derbyshire, Martin Cassidy 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: Pollack C, et al 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: 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: 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:

12 COBAS, LIFE NEEDS ANSWERS, COBAS H, ROCHE CARDIAC are trademarks of Roche Roche Diagnostics Roche Diagnostics Limited Charles Avneue Burgess Hill, RH15 9RY PM 1910

cobas h 232 POC system The power to make decisions in cardiac emergencies

cobas h 232 POC system The power to make decisions in cardiac emergencies cobas h 232 POC system Rapid results at the Point of Care (POC) Wherever and whenever you face an emergency situation, measurement