cobas h 232 systemWhen on the spot cardiac decisions

need on the spot results in Primary Care

cobas cardio

Is there a better pathway?Without Point of Care (POC) testing

With 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

Patient presents

POC test gives on the spot result

Appropriate action taken

POC test inonly 12 minutes

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

cobas cardio

Introducing the new cobas h 232 systemDesigned for on the spot cardiac decisions

Ease of use• Insert strip, apply sample,

read result

• Intuitive touch-screen

• No maintenance

• Easy to clean

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

Speed• Results available in

8–12 minutes

• Rapid, on-the-spot decision

support for treatment,

referral, or discharge of

cardiovascular patients

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

Portability• Portable device which

is suitable for use in

the GP’s surgery, one

stop clinics or

community hospitals

cobas cardio

Test Strip & Parameter Reaction Time Measuring Range Clinical Utility Cut-offMaterial Order No.

Roche CARDIAC D-Dimer D-dimer 8 mins 0.1–4.0 µg/mL Exclusion of deep vein 0.5 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 heart failure < 125 pg/mL

Risk stratification in Exclusion of acute heart failure

acute coronary syndrome < 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

50-75 > 900 pg/mL

> 75 > 1800 pg/mL

Roche CARDIAC T Quantitative Troponin T 12 mins 0.03–2 ng/mL Diagnosis of acute coronary < 0.03 ng/mL – low risk

04877772 190 (quantitative range syndrome and myocardial 0.03–0.1 ng/mL– medium risk

0.1–2 ng/mL) infarction > 0.1 ng/mL – high risk

Roche CARDIAC M** Myoglobin 8 mins 30–700 ng/mL Early marker of myocardial 70 ng/mL

04877799 190 damage to assist in diagnosis of

acute coronary syndrome and

myocardial infarction

Roche CARDIAC CK-MB CK-MB 12 mins 1.0–40 ng/mL Diagnosis of acute coronary Female:

04877900 190 syndrome and myocardial 4 ng/mL*

infarction, assessment of Male:

re-infarction 7 ng/mL*

cobas h 232

– when you need to be sure3 simple steps to quick results

Slide in test strip Apply sample

(150 µL heparinized

whole blood)

Result appears on

screen within minutes

1 2 3

* 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-dimerD-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

cobas cardio

NT-proBNPBNP 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:

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

0

250

60% 44% 76% 76%

% r

educ

tion

200

150

100

50

Pre NT-proBNP

Post NT-proBNP

Adapted from reference 20

Troponin TCardiac 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

MyoglobinMyoglobin, 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

cobas cardio

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 12–24 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

Useful informationWebsites

NICE – National Institute for Clinical Excellencehttp://www.nice.org.uk/

SIGN – Scottish Intercollegiate Guidelines Networkhttp://www.sign.ac.uk/

DoH Publications and Statisticshttp://www.dh.gov.uk/PublicationsAndStatistics/Publications/Publications

PolicyAndGuidance/DH 4094275

Cardiology Pathwayhttp://www.18weeks.nhs.uk/public/

Practice Based Commissioninghttp://www.dh.gov.uk/assetRoot/04/13/13/97/04131397.pdf

Health Improvement Programmehttp://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 04880668 190

cobas h 232 analyzer

Roche CARDIAC Pipettes Dosing device for sample transfer from primary sampling tube. 11622889 190

Labelled to showrequired sample volume

Handheld Base Unit/ Battery pack recharging 04805658 001

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 04805640 001

cobas cardio

References1. 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: 1104–1121.

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: 1–8.

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): 162–164.

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: 167–179.

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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