Myoglobin Test Device MYO-W02B

INTENDED USE
The Myoglobin test card is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin in plasma or serum as an aid in the diagnosis of myocardial infarction (MI).
For professional in vitro diagnostic use only.

SUMMARY
Myoglobin (MYO) is a heme-protein normally found in skeletal and ardiac 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.  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. 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.

The Myoglobin test card  is a simple test utilizing a combination of anti-Myoglobin antibody coated particles and capture reagent to detect Myoglobin in serum or plasma. The minimum detection level is 1.5 ng/mL.