INTENDED USE

The One Step CKMB/ Myoglobin/ Troponin I Combo Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin, CKMB and cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

INTRODUCTION

Myoglobin (MYO), Creatine Kinase MB (CKMB) and cardiac Troponin I (cTnI) are proteins released into the bloodstream after cardiac injury. Myoglobin is a heme protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8 kDa.It constitutes about 2 percent of total muscle protein and is responsible for transporting oxygen within muscle cells.¹ When muscle cells are damaged, Myoglobin is released into the blood rapidly due to its relatively small size. The level of Myoglobin increases measurably above baseline within 2~4 hours post infarct, peaking at 9~12 hours, and returning to baseline within 24~36 hours.^2,3 CKMB is an enzyme also present in the cardiac muscle, with a molecular weight of 87.0 kDa.⁴ Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B”, which combine to form three different isoenzymes, CKMM, CKBB and CKMB. CKMB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.⁵ The release of CK-MB into the blood following an 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.⁶ Cardiac Troponin I is a protein found in cardiac muscle, with a molecular weight of 22.5 kDa.⁷ Troponin I is part of a three subunit complex comprised of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle.⁸ After cardiac injury occurs, Troponin I is released into the blood 4~6 hours after the onset of pain. The release pattern of Troponin I is similar to CKMB, but while CKMB levels return to normal after 72 hours, Troponin I remains elevated for 6~10 days, thus providing for a longer window of detection for cardiac injury.

The One Step Myoglobin/CKMB/Troponin I Combo Test Device (Whole Blood/Serum/Plasma) utilizes a combination of antibody coated particles and capture reagents to qualitatively detect Myoglobin, CKMB and Troponin I in whole blood, serum or plasma. The minimum detection level is 50 ng/mL Myoglobin, 5 ng/mL CKMB and 0.5 ng/mL Troponin I.

KIT COMPONENTS

The test contains anti Myoglobin antibody coated particles, anti CKMB antibody coated particles, anti Troponin I antibody coated particles, and capture reagents coated on the membrane.

Materials Provided

1.Test devices

a.Droppers

b.Buffer

2.Package insert

PROCEDURE

Allow the test, specimen 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 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.

2.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. See illustration below.

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 40 µL) and start the timer. See illustration below.

For Fingerstick Whole Blood specimens: 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 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 results after 20 minutes.

INTERPRETATION OF RESULTS