Cardiac CK-MB Rapid One Step Test with CE certificate Test Device

For professional in vitro diagnostic use only.

INTENDED USE

The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human CK-MB in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

Sensitivity and Specificity

The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial CK-MB EIA test using clinical specimens. The results show that the sensitivity of the CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is 100% and the specificity is 99.8% relative to the leading EIA test.

CK-MB Rapid Test vs. EIA

Relative Sensitivity: 100% (93.5%-100.0%) *

Relative Specificity: 99.8% (98.7%-99.9%)*

Accuracy: 99.8%(98.9% to 99.9%)* 95% Confidence Interval

SUMMARY

Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa.¹ Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B” which combine to form three different isoenzymes, CK-MM, CK-BB, and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.² The release of CK-MB into the blood following MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours.³ CKMB is one of the most important cardiac markers and is widely recognized as the traditional marker for the diagnosis of MI.

The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-CK-MB antibody coated particles and capture reagent to detect CK-MB in whole blood, serum or plasma. The minimum detection level is 5 ng/mL.