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: [email protected] 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