INTENDED USE

The Myoglobin Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human Myogobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

SUMMARY

Myoglobin (MYO) is a heme-protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8kDa.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 Rapid Test is a simple test that utilizes a combination of anti-Myoglobin antibody coated particles and capture reagents to qualitatively detect Myoglobin in whole blood, serum or plasma. The minimum detection level is 50ng/mL.

PRINCIPLE

The Myoglobin Rapid Test is a qualitative, membrane based immunoassay for the detection of Myoglobin in whole blood, serum or plasma. The membrane is precoated with specific capture antibodies in the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line. The presence of this colored line in the specific test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.