The CK-MB Rapid Test Cassette (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).
Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa.1Creatine 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. 3 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 Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated particles and capture reagents to qualitatively detect CK-MB in whole blood, serum or plasma. The minimum detection level is 5 ng/mL CK-MB.
How to use?
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately50 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 75 μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1drop of buffer (approximately 40 μL) and start the timer. See illustration below.
To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 μL) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:*A colored line in the control line region (C) and the presence of another colored line in the test line regions indicates a positive result. This indicates that the concentration of CK-MB is above the minimum detection level.
*NOTE: The intensity of the color in the test line region(s) will vary depending on the concentration of CK-MB present in the specimen. Therefore, any shade of color in the test line regions should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).This indicates that the concentration of CK-MB are below the minimum detection levels.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.