Cardiac Myoglobin Rapid One Step Test with CE certificate Test
Device
| Product Name | Cardiac Myoglobin One Step Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is a
rapid chromatographic immunoassay for the qualitative detection of
human Myoglobin in whole blood, serum or plasma as an aid in the
diagnosis of myocardial infarction (MI).
Sensitivity and Specificity
The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) has been
evaluated with a leading commercial Myoglobin EIA test using
clinical specimens. The results show that the sensitivity of the
MYO Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is 100%
and the specificity is 97.8% relative to the leading EIA test.
Myoglobin Rapid Test vs. EIA
| Method | EIA | Total Results |
| Myoglobin Rapid Test | Results | Positive | Negative |
| Positive | 59 | 8 | 67 |
| Negative | 0 | 356 | 356 |
| Total Results | 59 | 364 | 423 |
Relative Sensitivity: 100% (94.0%-100%)*
Relative Specificity: 97.8% (95.7%-99.0%)*
Accuracy: 98.1% (96.3%-99.2%)* 95% Confidence Interval
SUMMARY
Myoglobin (MYO) is a heme-protein normally found in skeletal and
cardiac muscle with a molecular weight of 17.8 kDa. It constitutes
about 2 percent of total muscle protein and is responsible with
transporting oxygen within the muscle cells.1 When the muscle cells are damaged, Myoglobin is released to the
blood rapidly due to its relatively small size. Following the death
of tissue associated with MI, Myoglobin is one of the first markers
to rise above normal levels. The level of Myoglobin increases
measurably above baseline within 2-4 hours post-infarct, peaking at
9-12 hours, and returning to baseline within 24-36 hours.2,3 A number of reports suggest the measurement of Myoglobin as a
diagnostic aid in confirming the absence of myocardial infarction
with negative predictive values of up to 100% reported at certain
time periods after onset of symptoms.4
The One Step Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma)
is a simple test utilizing a combination of anti-Myoglobin antibody
coated particles and capture reagent to detect Myoglobin in whole
blood, serum or plasma. The minimum detection level is 50 ng/mL.
