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LABGEO IB10 Disease, Biomarkers, Product Overview
• Cardiology is a medical specialty dealing with disorders of the heart.
• The field includes diagnosis and treatment of congenital heart defects, coronary
artery disease, heart failure, alular heart disease and electrophysiology.
• Physicians specializing in this field of medicine are called cardiologists.
• Cardiologists should not be confused with cardiac surgeons, cardiothoracic and
cardiovascular, who are surgeons who perform cardiac surgery via sternotomy -
open operative procedures on the heart and great vessels.
Cardiology
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The Heart
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THE Heart
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Structure of Heart
Cardiovascular disease • It may sound like a single disease, but cardiovascular disease is actually a group of over
60 disorders of the heart or blood vessel system.
• High blood pressure, heart disease, and stroke are the most common forms.
• In the world, India has one of the highest numbers of cases related to heart diseases.
• According to the California-based CADI (Coronary Artery Disease among Asian Indians)
Research Foundation, India will have 62 million heart patients by 2015.
Types of Heart Diseases
• Coronary heart disease (CHD)/Coronary Artery Disease (CAD)
• Myocardial infarction or Heart Attack
• Acute Coronary Syndrome (ACS)
• Angina pectoris
• Congestive heart failure
• Cardiomyopathy
• Congenital heart disease
• Arrhythmias
Ti e is of Esse ce…. •According to a study conducted by U.S Department Of Health and Human Services..
NSTEMI is non diagnostic of ECG more than 50% of the time and 5% ACS are
missed.
When a heart attack occurs, quick diagnosis and medical treatment can restore
the blood flow to the heart and keep heart muscle from dying. But this can
happen only if proper diagnosis of severity of attack is available.
In general, there will be less heart damage if the blocked coronary artery can
be opened quickly, and blood flow restored. Treatments work best if given as
soon as possible, ideally within 30 minutes after symptoms begin.
Once a part of the heart muscle has died, nothing can be done to restore it.
Note:
Chest pain can be a symptom of other serious conditions besides a heart attack.
In such conditions, it becomes imperative that Cardiac Markers must be identified with
In 30 minutes so that proper line of treatment is provided.
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Time Is of Essence (contd)….
•The Role of Emergency Medical Services
Emergency medical personnel arrive fast and can start treatment right away based on
analyses of the report.
They can administer heart medicine, pain relief medicine, or other medications, such as
aspirin, based upon the extend of severity and can help in case of a heart attack.
In many locations, emergency medical personnel are linked to the hospital, so they can
send information about a patient’s condition to the emergency department even
before the patient arrives.
Heart attack patients who are brought by ambulance tend to receive faster
treatment when they arrive at the hospital provided that the initial investigations are al
ready done in the ambulance and the attending specialists can straightaway jump to
proper line of treatment without waiting for any further analyses.
What are Cardiac Markers • In 2001, an NIH working group standardized the definition of a biomarker as a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention
Attributes of an Ideal Biomarker
• Found in high concentrations in the heart
• Not found in other tissues, even in trace amounts or under pathological conditions
• Low molecular weight released early in course of ACS (ideally prior to cardiac
necrosis)
• Peaks early and remains detectable for several days
• Provides risk stratification
- Elevation proportional to injury size and risk
-Triggers beneficial therapy
• Short TAT
• Inexpensive
• No such marker exists that meets these criteria
Morrow DA & de Lemos JA. Circulation. 2007;115:949-52. Vasan RS. Circulation. 2006;113:2335-62.
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Role of Biomarkers
Appearance of Cardiac Markers
Myeloperoxidase
Myoglobin CK-MB
C-Reactive Protein
B-type Natriuretic Peptide
Troponin I
0 0-3 3-6 6-12 12-24 24-48
Hours After Pain Onset
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Which markers for which indications
Indications for Use NT-
proBNP TnI CKMB Myo D-dimer
Aids in diagnosis of AMI - -
Stratifies the risk of
ACS - - -
Aids in diagnosis of CHF - - - -
Assesses disease
severity of CHF - - - -
Rules out DVT/PE - - - -
Stratifies the risk of
acute PE - - -
Role of Biomarkers in disease
a age e t…
Troponin I – Diagnosis of Myocardial Infarction
Myoglobin – Early rise in diagnosis of Myocardial infarction
CK-MB – Detection of myocardial damage & re-infarction
NT-proBNP – Diagnosis & risk stratification of patients with Heart Failure
D-Dimer – For assessment and evaluation of patients presenting with clinical
symptoms of Venous Thromboembolism (VTE) including severely evolving
Disseminated Intravascular Coagulation (DIC), pulmonary embolism (PE) and deep
vein thrombosis (DVT).
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B10 concept B10 Disc.
[Test kit Disc.: Max. 3 strips]
Semi-Quantitative Test
Point of Care Test
Time to result : <20min
Centrifugation : Autonomic centrifugation
inside the reader
Multiple parameter
- No additional time required to test more parameters
- Disc type allows to test
multiple parameter
Type of sample : Whole blood,
plasma, serum
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Disc calibration
• Each lot of disc is calibrated to ensure
that lot –to-lot variability is minimized.
• Lot specified calibration along with
additional information such as the lot
expiration date is contained on a QR
code label affixed to each disc.
• It is recommended that external
controls be tested at appropriate time
intervals to confirm that the system and
test lot are performing within acceptable
limits.
Key Features co t… • Point-of-care testing: Test to result within 20 minutes • Multiple parameters: Cardiac markers & infectious diseases • Mobile laboratory: Small size & light weight suitable for emergency ambulances, transit ICCUs Battery power supported • Convenience: No sample preparation needed Plasma separation done in the reagent disc • Size / Weight: 177 x 330 x 177 / 2.4kg • Sample volume: 500µl • Options: Battery, Barcode reader • IT solution: Samsung LABGEO Data Manager • Proactive Service: RMS (Remote Management System) • Test Select feature allows running desired tests and billing accordingly • Measures, Displays, Prints, Stores & Uploads Results
Stability
- Provide longer stability
. 4 weeks at room temp.
. 1 year if refrigerated
Performance
- More accurate data using State of Art Tech.
. Adaption of centrifugal microfluidics tech.
to control the exact amount of sample
. Consistent temp. management at 37.0℃
during reaction.
Connectivity
- Various port support
. USB, LAN Port
- LIS connection
. Support HL7, ASTM protocols, POCT-1A
Ease of Use
- No calibration needed
. No code chip required
. Calibration data are provided automatically
from QR code attached on each discs
- Graphical User-interface requires minimum
Trainings
- User friendly design (IF award 2012)
Take Home Message • NSTEMI is non diagnostic of ECG more than 50% of the time and 5% ACS are
missed.
• Therefore Biomarkers like Troponin I helps to rule out MI
• A Panel of CV biomarkers needs to considered before Ruling out MI.
• CV Biomarkers Improves Decision making and Risk stratification.
• IB10 – Runs single and multiple parameters on single platform
• Largest memory storage