Accurate, Fast, and Reliable Detection of Acute Myocardial Infarction (AMI)
✅ Intended Use
The Cardiac Troponin I (cTnI) Rapid Test Cassette is a lateral flow immunoassay designed for qualitative detection of cardiac Troponin I in human whole blood, serum, or plasma. It is used as a diagnostic aid for acute myocardial infarction (AMI), commonly known as a heart attack.
🧬 About the Test
Cardiac Troponin I (cTnI) is a heart-specific protein that regulates muscle contraction. It is released into the bloodstream within 4–6 hours of myocardial injury, peaking between 60–80 hours, and may remain detectable for up to 10–14 days.
This rapid test offers:
- Quick results within 15 minutes
- High specificity to cardiac muscle injury
- Non-invasive testing for early AMI diagnosis
- Ideal for use in emergency care and critical situations
🧪 How the Test Works
This qualitative immunoassay uses monoclonal anti-cTnI antibodies immobilized on a nitrocellulose membrane. When a sample is applied, any present cTnI binds to the antibodies, forming a visible colored line on the test strip.
- Positive Result: Two lines (Test + Control)
- Negative Result: One line (Control only)
- Invalid Result: No Control line – retest required
⚠️ Precautions
- For in vitro diagnostic use only
- Healthcare professionals only
- Do not use past expiration date
- Handle all specimens as potentially infectious
- Dispose of all test components according to local regulations
📦 Test Kit Components
Included:
- Test cassette
- Buffer
- Dropper
- Package insert
Required (Not Provided):
- Sample collection materials
🌡️ Storage & Stability
- Store sealed at 4°C–30°C (40°F–86°F)
- Use within 1 hour of opening
- Avoid heat, humidity, or direct sunlight
🧫 Specimen Collection & Handling
- Suitable for whole blood, serum, or plasma
- Collect via venipuncture using EDTA, citrate, or heparin
- Store at 2–8°C for up to 7 days
- For long-term storage, freeze serum/plasma; do not freeze whole blood
🔍 Test Procedure
- Bring test and specimen to 15–30°C
- Place cassette on a flat surface
- For serum/plasma: Add 3 drops (100 µL) to specimen well
- For whole blood: Add 2 drops (70 µL) + 1 drop buffer (35 µL)
- Wait 15 minutes to read results; do not interpret after 20 minutes
📊 Results Interpretation
| Result | Interpretation |
|---|---|
| Positive | Two lines (T + C): cTnI detected |
| Negative | One line (C only): No detectable cTnI |
| Invalid | No control line: Repeat test |
🧪 Quality Control
An integrated control line (C) confirms test validity. For best practice, run routine positive and negative controls to ensure ongoing reliability.
📈 Performance Highlights
- Sensitivity: ≥0.5 ng/mL
- Clinical Sensitivity: 99.08%
- Clinical Specificity: 99%
- Accuracy: 99%
- Reproducibility: 99.8% agreement across testing sites
📚 Scientific References
- Adams et al., N. Engl. J. Med., 1994 – Detection of myocardial infarction with cTnI
- Hossein-Nia et al., Ann. Thorac. Surg., 1996 – Troponin I in heart transplantation
- Alpert JS et al., J. Am. Coll. Cardiol., 2000 – Redefining myocardial infarction