OnSite Troponin I Rapid TestEarly Detection Enables Immediate Action

Better Management for Acute Myocardial Infarction

• A heart attack occurs when blood flow to a part of heart is blocked for a long enough time

• Irreversible necrosis of heart muscle

• One of the acute coronary syndromes (ACS)

Acute Myocardial Infarction (AMI)

• The leading cause of morbidity and mortality worldwide

o 50% of all deaths in industrialized countries

o Main causes of death in developing countries

AMI Risk

• Typical chest paino Substernal pressure sensation, aching, burning, or sharpo Intense and unremitting for 30-60 minuteso Often radiates up to neck, shoulder, and ulnar aspect of left armo May have a feeling of indigestion or of fullness and gas

• Vital signo Increased heart rateo Arrhythmia: ventricular tachycardia, atrial fibrillation/fluttero Blood pressure: elevated; hypotension with right ventricular MI or

severe left ventricular dysfunctiono Increased respiratory rate o Coughing, wheezing, and frothy sputumo Fever, may exceed 102°F

Clinical Symptoms and Signs

Early Diagnosis Is Extremely Important

Time Histopathological Change of Myocardium Outcome

0-0.5 hrs Glycogen loss and mitochondrial swelling Reversible

0.5-4 hrs Glycogen depletion Reversible

4-12 hrs • Initiation of coagulation necrosis• Edema• hemorrhage

Irreversible

12-24 hrs • Ongoing coagulation necrosis• Neutrophil infiltration

Irreversible

• Critical for the immediate treatment due to a limited time window

Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit, together with at least one of the following:

• Symptoms of ischaemia o Typical chest pain lasting for more than 20 minutes

• ECG changes o new ischaemia (new ST-T changes, or new left bundle branch block

(LBBB))o development of pathological Q-wave

• Coronary artery intervention (e.g., coronary angioplasty)

The New Criteria for Diagnosis of AMI

Elevation of Cardiac Biomarkers after AMI

GP BB Troponin Myoglobin CK-MB LDH

History Latest 2nd Gen. 1st generation of cardiac biomarkers

Sensitivity & specificity

High Highest Low specificity

Relatively specific

Not as specific as troponin

Raise time 1-3 hrs 2-4 hrs 2-4 hrs 4-6 hrs 4-6 hrs

Peak 7 hrs 12 hrs 6-12 hrs 10-24 hrs 72 hrs

Cardiac Troponin I and T

Cardiac troponin is an early, accurate, and stable biomarker

• Recommended by the American College of Cardiology (ACC) and the European Society of Cardiology (ESC) as the key of definition of AMI

• 1 elevated level is sufficient to establish the diagnosis of AMI, by using the 0.6 ng/mL cutoff for normalo No repeat testing is needed

• Increased cTnI/cTnT is used to establish NSTEMI on the patients with o unstable angina or minor myocardial injuryo negative CK-MB values o in the absence of diagnostic ECG changes

Troponin Assay is Recommended

• Any patient presenting with a possible ACS

• Routinely following percutaneous coronary intervention

• Routinely following surgical revascularization, coronary artery bypass graft

Indication of Troponin Assay

A positive Troponin is associated with increased risk of an adverse outcome at 30 days.

• Both rise in 2-4 hours after AMI, and peak at 12-24 hours

• cTnI remains raised for 5-7 days, cTnT for more than 2 weeks

• Equivalent sensitivity & specificity; No scientific evidence that either of these markers is superior to the other

• No POCT for cTnT is available

• POCT for cTnI is available on the market

• cTnI is cost effective

Troponin Assay - cTnI or cTnT ?

Troponin I assay is an ideal and realistic method

• Easy of use in any settingo Can use whole blood specimens o No equipment requirement o Product to be stored and shipped at room temperature

• Fast result o Results available within 15 minutes o Reduce stay in ED around 25 minutes

• Minimal training is needed o Simple procedureo Allows every health care professionals to perform the test

Aid in the diagnosis of AMI in emergency room, critical care, point of care and hospital settings, or even remote area, patient home, and ambulance

OnSite Troponin I Rapid Test is Ideal for AMI

OnSite Troponin I Rapid Test Kits in 2 Formats

Catalog Product Specimen Time to Result

R3001C OnSite Troponin I Rapid Test CE Serum/Plasma 15 min

R3002C OnSite Troponin I Combo Rapid Test CE Serum/Plasma/ whole Blood

15 min

Simple Procedure with Minimal Training Required

OnSite Troponin I Rapid Test (R3001C) OnSite Troponin I Combo Rapid Test (R3002C)

Whole blood can be tested with R3002C

Clear, Easy to Read Result

Only C line is developed

Both C and T line are developed

Negative Positive

Positive results need to be confirmed with other methods before any further action should be taken

- ECG is a simple confirmatory test -

Clinical Performance

• Sufficient Sensitivity

o Detect 0.5 ng/mL or greater total cTnI in serum or plasma

o Detect 1 ng/mL or greater total cTnI in whole blood

• The following substances were added to troponin I negative and 1.0 ng/mL troponin I spiked serum samples. No interference was found with any of the substances at the following concentrations:

o Bilirubin 10 mg/dL

o Cholesterol 800 mg/dL

o Hemoglobin 250 mg/dL

o Triglyceride 1250 mg/dL

Clinical Performance

• USA brand

• Utilize polyclonal and monoclonal antibody pair to minimize false positive results

• Proper detection limit enables high specificity o Calibrated against NIST total cTnI standardo No false positive complaint reported since it is released

• A true POCT, can be used with whole blood specimen

• Prompt technical support from our technical specialist with 15 yrs work experience as cardiologist

OnSite Troponin I Rapid Test Competes Over Other’s

OnSite Troponin I Rapid Test Kits

Typical chest pain

Positive

Confirm AMI with ECG

Negative

1. Symptom & ECG monitoring

2. re-test later

Recommended Troponin I Detection Algorithm

• OnSite GP BB Rapid Testo Latest recognized cardiac marker o Rise earlier than cTnIo High sensitivity and specificity

More Cardiac Markers Available in Future

Technical Support

Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

THANK YOU

QUALITY . INNOVATION . SIMPLICITY

Troubleshooting

False positive result• It is the nature of in vitro diagnosis • Interference substance or condition • Product is not stored properly• Test procedure is altered: • add too much specimen, or• extend recommended reading time

Any positive result needs to be confirmed with other methods before any further action taken • ECG is a simple confirmatory test

Troubleshooting

False negative result• The level of cardiac marker at the time that specimen is taken, is under

the detectable level • Unknown interference substance or condition • Product is not stored properly • Test procedure is not followed:

o add less specimen, oro too much sample diluent

If symptom is highly suspected• Take sample few hours late, and re-test• Test with alternative method, such as ECG