Cardiac Myoglobin Rapid One Step Test with CE certificate Test Device

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

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.