Chest-pain triage
Supports rapid assessment when patients present with possible AMI and laboratory turnaround time is critical.
IVD / Cardiac Marker
A professional-use lateral flow panel for qualitative detection of three key cardiac injury markers from whole blood, serum, or plasma.

Product Overview
The Myoglobin / CK-MB / Troponin I Rapid Test is a lateral flow immunoassay for qualitative detection of myoglobin, creatine kinase MB, and cardiac troponin I. It is intended for professional in vitro diagnostic use as an aid in assessment of suspected acute myocardial infarction.
Medical Background
Acute myocardial infarction causes cardiomyocyte necrosis. As cell membranes lose integrity, intracellular proteins enter circulation in a time-dependent sequence. A combined panel helps providers see early, mid, and sustained marker windows in one test.
Myoglobin contributes early sensitivity, CK-MB supports the diagnostic window, and troponin I remains useful later after symptom onset.
Clinical Use
Supports rapid assessment when patients present with possible AMI and laboratory turnaround time is critical.
Whole blood compatibility allows testing closer to patient care while serum or plasma can be used in laboratory settings.
Combines early, intermediate, and sustained markers so providers can interpret results in relation to symptom timing.
Procedure & Results
Bring cassette and specimen to room temperature, 15-30 C. Remove cassette from sealed pouch and place on a level surface.
Serum/plasma: add 3 drops, about 100 uL. Whole blood: add 2 drops, about 70 uL, then 1 drop buffer.
Start timer immediately after adding sample and buffer.
Interpret at 15 minutes. Do not read after 20 minutes.
Control line plus one or more marker test lines appear. Report the visible marker line(s) as reactive at or above cutoff.
Only the control line appears. Marker levels are below cutoffs. This does not exclude AMI when clinical suspicion remains high.
No control line appears. Repeat with a new cassette and review specimen volume and procedure.
Specimen Handling
| Marker | Cutoff | Normal range |
|---|---|---|
| Troponin I | >= 0.5 ng/mL | < 0.5 ng/mL |
| CK-MB | >= 5 ng/mL | < 5 ng/mL |
| Myoglobin | >= 50 ng/mL | 30-90 ng/mL |
Qualitative test: line intensity does not correlate with concentration.
Specifications
Leaflet performance: cTnI sensitivity 99.09%, specificity 98.95%, accuracy 99.00%; CK-MB sensitivity 97.87%, specificity 99.03%, accuracy 98.67%; myoglobin sensitivity 97.62%, specificity 99.31%, accuracy 98.83%.
For professional IVD use only. Do not reuse. Do not use if pouch is damaged or expired. Follow specimen handling precautions and treat all clinical samples as potentially infectious.
Results should be interpreted with symptoms, ECG, clinical history, and other diagnostic findings. A negative rapid test does not independently rule out myocardial infarction.