Transcript OnSite Troponin I Rapid Test Early Detection Enables

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
o
50% of all deaths in industrialized
countries
o
Main causes of death in developing
countries
Clinical Symptoms and Signs
• Typical chest pain
o Substernal pressure sensation, aching, burning, or sharp
o Intense and unremitting for 30-60 minutes
o Often radiates up to neck, shoulder, and ulnar aspect of left arm
o May have a feeling of indigestion or of fullness and gas
• Vital sign
o Increased heart rate
o Arrhythmia: ventricular tachycardia, atrial fibrillation/flutter
o Blood pressure: elevated; hypotension with right ventricular MI or
severe left ventricular dysfunction
o Increased respiratory rate
o Coughing, wheezing, and frothy sputum
o 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
Reversible
4-12 hrs
•
•
•
Initiation of coagulation necrosis
Edema
hemorrhage
Irreversible
Ongoing coagulation necrosis
Neutrophil infiltration
Irreversible
12-24 hrs •
•
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
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)
Elevation of Cardiac Biomarkers after AMI
Cardiac Troponin I and T
History
Sensitivity
& specificity
Raise time
Peak
GP BB
Troponin
Myoglobin
CK-MB
LDH
Latest
2nd Gen.
High
Highest
Low
specificity
Relatively
specific
Not as specific
as troponin
1-3 hrs
2-4 hrs
2-4 hrs
4-6 hrs
4-6 hrs
7 hrs
12 hrs
6-12 hrs
10-24 hrs
72 hrs
1st generation of cardiac biomarkers
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
o
No repeat testing is needed
• Increased cTnI/cTnT is used to establish NSTEMI on the patients with
o unstable angina or minor myocardial injury
o negative CK-MB values
o 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
Troponin I assay is an ideal and realistic method
OnSite Troponin I Rapid Test is Ideal for AMI
• Easy of use in any setting
o 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 procedure
o 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
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
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
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
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:
o
Bilirubin 10 mg/dL
o
Cholesterol 800 mg/dL
o
Hemoglobin 250 mg/dL
o
Triglyceride 1250 mg/dL
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
o Calibrated against NIST total cTnI standard
o 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
o Latest recognized cardiac marker
o Rise earlier than cTnI
o High sensitivity and specificity
Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739
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, or
o too much sample diluent
If symptom is highly suspected
• Take sample few hours late, and re-test
• Test with alternative method, such as ECG