OnSite Troponin I Rapid Test Early Detection Enables Immediate Action Better Management for Acute Myocardial Infarction

Acute Myocardial Infarction (AMI) 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)

AMI Risk The leading cause of morbidity and mortality worldwide 50% of all deaths in industrialized countries Main causes of death in developing countries

Clinical Symptoms and Signs Typical chest pain Substernal pressure sensation, aching, burning, or sharp Intense and unremitting for 30-60 minutes Often radiates up to neck, shoulder, and ulnar aspect of left arm May have a feeling of indigestion or of fullness and gas Vital sign Increased heart rate Arrhythmia: ventricular tachycardia, atrial fibrillation/flutter Blood pressure: elevated; hypotension with right ventricular MI or severe left ventricular dysfunction Increased respiratory rate Coughing, wheezing, and frothy sputum Fever, may exceed 102°F

Early Diagnosis Is Extremely Important Critical for the immediate treatment due to a limited time window Time Histopathological Change of Myocardium Outcome 0-0.5 hrs Glycogen loss and mitochondrial swelling Reversible 0.5-4 hrs Glycogen depletion 4-12 hrs Initiation of coagulation necrosis Edema hemorrhage Irreversible 12-24 hrs Ongoing coagulation necrosis Neutrophil infiltration

The New Criteria for Diagnosis of AMI 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 Typical chest pain lasting for more than 20 minutes ECG changes new ischaemia (new ST-T changes, or new left bundle branch block (LBBB)) development of pathological Q-wave Coronary artery intervention (e.g., coronary angioplasty)

Elevation of Cardiac Biomarkers after AMI Cardiac Troponin I and T 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 4-6 hrs Peak 7 hrs 12 hrs 6-12 hrs 10-24 hrs 72 hrs Cardiac troponin is an early, accurate, and stable biomarker

Troponin Assay is Recommended 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 normal No repeat testing is needed Increased cTnI/cTnT is used to establish NSTEMI on the patients with unstable angina or minor myocardial injury negative CK-MB values in the absence of diagnostic ECG changes

Indication of Troponin Assay Any patient presenting with a possible ACS Routinely following percutaneous coronary intervention  Routinely following surgical revascularization, coronary artery bypass graft A positive Troponin is associated with increased risk of an adverse outcome at 30 days.

Troponin Assay - cTnI or cTnT ? 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 Only Roche has cTnT product Troponin I assay is an ideal and realistic method

OnSite Troponin I Rapid Test is Ideal for AMI Easy of use in any setting Can use whole blood specimens No equipment requirement Product to be stored and shipped at room temperature Fast result Results available within 15 minutes Reduce stay in ED around 25 minutes Minimal training is needed Simple procedure 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 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

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 - ECG is a simple confirmatory test - Negative Positive Only C line is developed Both C and T line are developed 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 Detect 0.5 ng/mL or greater total cTnI in serum or plasma Detect 1 ng/mL or greater total cTnI in whole blood

Clinical Performance 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: Bilirubin 10 mg/dL Cholesterol 800 mg/dL Hemoglobin 250 mg/dL Triglyceride 1250 mg/dL High specificity assure less false positive results

OnSite Troponin I Rapid Test Competes Over Other’s USA brand Utilize polyclonal and monoclonal antibody pair to minimize false positive results Proper detection limit enables high specificity Calibrated against NIST total cTnI standard 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

Recommended Troponin I Detection Algorithm OnSite Troponin I Rapid Test Kits Typical chest pain Positive Confirm AMI with ECG Negative 1. Symptom & ECG monitoring 2. re-test later

More Cardiac Markers Available in Future OnSite GP BB Rapid Test Latest recognized cardiac marker Rise earlier than cTnI High sensitivity and specificity

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

QUALITY . INNOVATION . SIMPLICITY THANK YOU

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: add less specimen, or too much sample diluent If symptom is highly suspected Take sample few hours late, and re-test Test with alternative method, such as ECG