IVD / Cardiac Marker

Myoglobin / CK-MB / Troponin I Rapid Test

A professional-use lateral flow panel for qualitative detection of three key cardiac injury markers from whole blood, serum, or plasma.

3 markers / 1 cassette15-minute resultProfessional use only
Cardiac marker rapid test product box and pouch

Product Overview

Rapid multi-marker support for suspected acute myocardial infarction.

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.

15 minRead time
3Cardiac markers
WB / S / PSpecimen types
IVDProfessional use

Medical Background

Why three markers matter

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.

MyoglobinEarly marker. First rise around 1-3 hours; peaks around 4-8 hours; usually returns toward baseline within 12-24 hours.
CK-MBIntermediate marker. Rises around 4-6 hours; peaks at 12-24 hours; may remain elevated for 36-48 hours.
Troponin ICardiac-specific injury marker. Rises around 4-6 hours and can remain elevated for 7-14 days.

Cardiac marker kinetics after AMI onset

Relative concentrationHours from AMI onset clinical cutoff zone Myoglobin CK-MB Troponin I 02612244872

Myoglobin contributes early sensitivity, CK-MB supports the diagnostic window, and troponin I remains useful later after symptom onset.

Clinical Use

Where the panel fits in provider workflows

ED

Chest-pain triage

Supports rapid assessment when patients present with possible AMI and laboratory turnaround time is critical.

POC

Point-of-care support

Whole blood compatibility allows testing closer to patient care while serum or plasma can be used in laboratory settings.

3X

Broader marker coverage

Combines early, intermediate, and sustained markers so providers can interpret results in relation to symptom timing.

Procedure & Results

Simple cassette workflow

1Prepare

Bring cassette and specimen to room temperature, 15-30 C. Remove cassette from sealed pouch and place on a level surface.

2Add specimen

Serum/plasma: add 3 drops, about 100 uL. Whole blood: add 2 drops, about 70 uL, then 1 drop buffer.

3Run test

Start timer immediately after adding sample and buffer.

4Read

Interpret at 15 minutes. Do not read after 20 minutes.

Positive

MKTC

Control line plus one or more marker test lines appear. Report the visible marker line(s) as reactive at or above cutoff.

Negative

MKTC

Only the control line appears. Marker levels are below cutoffs. This does not exclude AMI when clinical suspicion remains high.

Invalid

MKTC

No control line appears. Repeat with a new cassette and review specimen volume and procedure.

Specimen Handling

Use clear, properly handled specimens

Specimen typesHuman whole blood, serum, or plasma.
Whole bloodCollect venous whole blood in EDTA or heparin tube. Store at 2-8 C for up to 5 days. Do not freeze whole blood.
Serum / plasmaSeparate as soon as possible to avoid hemolysis. Store at 2-8 C for up to 7 days, or at -20 C for longer storage.
AvoidGrossly hemolyzed, lipemic, or turbid samples, as these may interfere with interpretation.

Detection cutoffs

MarkerCutoffNormal range
Troponin I>= 0.5 ng/mL< 0.5 ng/mL
CK-MB>= 5 ng/mL< 5 ng/mL
Myoglobin>= 50 ng/mL30-90 ng/mL

Qualitative test: line intensity does not correlate with concentration.

Specifications

Product information from leaflet and IFU

Product nameMyoglobin / CK-MB / Troponin I Rapid Test
FormatCassette, 25 tests per box
Intended useQualitative detection of myoglobin, CK-MB, and cardiac troponin I in human whole blood, serum, or plasma; aid in suspected AMI assessment
MethodSandwich lateral flow immunochromatographic assay
SpecimenWhole blood, serum, or plasma
Read time15 minutes; do not read after 20 minutes
Storage4-30 C in sealed pouch; protect from sunlight, moisture, and heat
After openingUse within 1 hour
ComponentsTest cassette, dropper, buffer vial, desiccant, IFU; single use only
Use settingProfessional and in vitro diagnostic use only

Performance

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%.

Warnings

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.

Clinical limitation

Results should be interpreted with symptoms, ECG, clinical history, and other diagnostic findings. A negative rapid test does not independently rule out myocardial infarction.