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