Cardiac Myoglobin Rapid One Step Test with CE certificate uncut sheet

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

Precision

Intra-Assay

Within-run precision has been determined by using replicates of 10 tests for each of three lots using Myoglobin specimen levels at 0 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL, and 400 ng/mL. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 3 independent assays on the same five specimens: 0ng/mL, 50ng/mL, 100 ng/mL, 200 ng/mL, and 400 ng/mL of Myoglobin. Three different lots of the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/ Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Interfering Substances

The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) has been tested and no interference was observed in specimens containing 110 mg/mL human albumin, 6 mg/mL bilirubin, 10 mg/mL hemoglobin, 5 mg/mL cholesterol and 15 mg/mL triglycerides.

The following compounds have also been tested using the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) and no interference was observed.