Cardiac Markers CK-MB Rapid Test Cassette One Step Detection

INTENDED USE

The One Step CK-MB 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).

INTRODUCTION

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 One Step CK-MB 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.

MAIN CONTENTS

• One pouch containing a reaction test Cassette with desiccant.

• Disposable pipettes.

• Buffer.

• Instructions for use.

DIRECTION OF USE

Allow the test, specimen and/or controls to reach room temperature (1530°C) prior to testing.

• Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
• Place the test device on a clean and level surface.

For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 mL) to the specimen well (S) of the test device, then start the timer..

For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 3 drops of venipuncture whole blood (approximately 75 mL) to the specimen well (S) of the test device, then add 1 drop of buffer(approximately 40mL) and start the timer.

For Fingerstick Whole Blood specimens:

To use a capillary tube: Fill the capillary tube and transfer approximately 75 mL of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer(approximately 40mL) and start the timer.

To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 mL) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer(approximately 40mL) and start the timer.

• Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes.

For detailed information, please contact Dewei person for Manual Instruction.