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

2. 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)

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

4. Clinical Symptoms and Signs
Typical chest pain
Substernal pressure sensation, aching, burning, or sharp
Intense and unremitting for 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

5. 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

6. 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)

7. 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

8. 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

9. 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.

10. Troponin Assay - cTnI or cTnT ?
Both rise in 2-4 hours after AMI, and peak at 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

11. 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

12. 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

13. 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

14. 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 -

15. 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

16. 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

17. 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

18. 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

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

20. Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA USA
Telephone: 1 (858) Fax: 1 (858)

21. QUALITY . INNOVATION . SIMPLICITY
THANK YOU

22. 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

23. 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