High Sensitivity 99.51% CK-MB Rapid Test Kit for Cardiac Marker in Whole Blood Serum or Plasma

CK-MB Rapid Test Kit

【INTRODUCTION】

Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa. 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. 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. CK-MB 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 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.

【INTENDED USE】

The CK-MB Rapid Test (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).

【PRINCIPLE】

The CKMB Rapid Test detects CKMB through visual interpretation of color development on the internal cassette. Anti-CKMB antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-CKMB antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is enough CKMB in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

【ADVANTAGES】

1. Easy to use, Can be used with whole blood, serum, or plasma samples;

2. Quick detection, within 15 minutes;

3. Highly cost-effective.

【DIRECTION OF USE】

Allow the test, specimen and/or controls to reach room temperature (15- 30°C) prior to testing.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.

2. Transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.

As the test begins to work, color will migrate across the membrane.

3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Do not interpret the result after 20 minutes.

4. Reading results:

【MANUFACTURER】

Dewei Medical Equipment Co., Ltd 

Adress: No.4 Building, Shiyou Industrial Park, Jun'an, Shunde, Foshan, China 528329

Email: sales@deweilab.com

For further operation or performance details, please refer to final instruction manual.