Post on 08-Mar-2015
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.
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Roche Diagnostics Limited
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