CK-MB Cardiac Blood Tests , Plasma Specimen Diagnostic Heart Tests Accurate

One Step CK-MB Rapid Diagnostic Test, diagnosis of CK-MB, gold colloidal method,quickly and easily

Intended Use:

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).

Summary:

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. 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 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.

Test Principle:

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 pre-coated 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.

TEST PROCEDURE

1.  Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2.  Remove the device from the sealed pouch and lay it on a flat and dry surface.

3.  Using the provided pipette, add one drop of fresh specimen to the sample well.

4.  Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid

cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5.  Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE:* Two 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) will vary depending on the concentration of TP antibodies 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.