CK-MB Rapid Test

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.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 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.

The CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of CK-MB in whole blood, serum or plasma. The membrane is precoated with specific capture antibodies in each of the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line. The presence of this colored line in the specific test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

1. Why is the CK-MB Test Important?

CK-MB (Creatine Kinase-Myocardial Band) is a specific enzyme found in heart muscle cells. When these cells are damaged or die due to causes like ischemia or hypoxia, CK-MB is released into the bloodstream, leading to an increase in its concentration. Therefore, measuring the level of CK-MB in the blood is a key biochemical marker for auxiliary diagnosis of acute myocardial infarction​ and other acute myocardial injuries. Its level begins to rise within hours after the onset of a heart attack, following a characteristic time curve, which aids in early diagnosis and dynamic monitoring.

2.What are the Typical Symptoms of Acute Myocardial Infarction?

The classic symptom of an acute myocardial infarction is chest pain. This pain is often described as crushing, squeezing, or suffocating discomfort​ located behind the breastbone or in the left chest. It is typically severe, lasts more than 30 minutes, and is not relieved by rest or nitroglycerin. The pain may radiate to the left shoulder, arm, neck, jaw, or back.In addition to chest pain, patients often experience profuse sweating, nausea or vomiting, shortness of breath, palpitations (irregular heartbeat), restlessness, and a sense of impending doom. It is crucial to be aware that some patients (e.g., the elderly or those with diabetes) may have atypical symptoms, presenting only with shortness of breath, extreme fatigue, confusion, or upper abdominal pain, which can lead to misdiagnosis.

3.Who Should Consider This Test and in What Scenarios?

The CK-MB rapid test is recommended for the following individuals or scenarios:

Individuals experiencing symptoms suggestive of a heart attack, such as acute chest pain, chest tightness, or shortness of breath, especially if the symptoms persist.

It is used for rapid auxiliary diagnosis.Individuals with risk factors for cardiovascular disease​ such as coronary artery disease, hypertension, diabetes, or hyperlipidemia, if they develop relevant discomfort, as part of risk assessment.Cases suspected of having myocarditis or cardiomyopathy, to help assess myocardial injury.Pre-hospital emergency settings (e.g., ambulances), emergency departments, and primary care facilities: Used for rapid initial screening and triage of patients with acute chest pain to save critical treatment time.

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

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

• Hold the dropper vertically, transfer 2 drops of the serum or plasma specimens (about 50μL) to the specimen area, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

• Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75μL) 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:

• Fill the capillary tube and transfer approximately 75μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40μL) 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.

POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) may vary depending on the concentration of CK-MB present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

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.

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