Rapid Diagnostic Test H - FABP and Myoglobin / CK - MB / Troponin I Combo

A rapid test for the diagnosis of myocardial infarction (MI) to detect h-FABP, Myoglobin, CK-MB and cardiac Troponin I (cTnI) qualitatively in whole blood, serum or plasma CE certified

Applications:

The H-FABP and Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human H-FABP, Myoglobin, CK-MB and cardiac Troponin I (cTnI) in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

Description:

Myoglobin (MYO), Creatine Kinase MB (CK-MB) 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.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 CK-MB 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, CK-MM, CK-BB and CK-MB. CK-MB 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 CK-MB, but while CK-MB 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.

FABP is a newly introduced plasma marker of acute myocardial infarction (AMI). The plasma kinetics of FABP (15 kD) closely resemble those of myoglobin in that elevated plasma concentrations are found within 2 hours after AMI and return to normal generally within 18 to 24 hours. But the concentration of FABP in the skeletal muscle is 20 times lower than in cardiac tissue (for myoglobin the same content for cardiac and skeletal tissue), that makes FABP to be more cardiac specific than
myoglobin. This makes FABP a useful biochemical marker for the early assessment or exclusion of AMI. FABP also appears to be a useful plasma marker for the estimation of myocardial infarct size. FABP is suitable for use as a standard in immunoassay for early detection of acute myocardial infarction, immunogen for antisera production, mass FABP standard, FABP biochemical and immunochemical studies, tracer for iodination.

The H-FABP and Myoglobin/CK-MB/Troponin I Combo 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 H-FABP, Myoglobin, CK-MB and cardiac Troponin I (cTnI) in whole blood, serum or plasma. The minimum detection level is 8ng/ml H-FABP, 50ng/ml Myoglobin, 5ng/ml CK-MB and 0.5ng/ml Troponin I.

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 as soon as possible.
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 (approximately 50 mL) to the specimen area respectively, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

• Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 mL) to the specimen area respectively, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

• To use a capillary tube: Fill the capillary tube and transfer approximately 50 mL of fingerstick whole blood specimen to the specimen area of test cassette respectively, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.
• To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 mL) to fall into the specimen area of test cassette respectively, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

1. 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 one or more colored lines in the test line regions indicates a positive result. This indicates that the concentration of h-FABP, Myoglobin, CK-MB and/or cardiac Troponin I 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 h-FABP, Myoglobin, CK-MB and/or cardiac Troponin I 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 h-FABP, Myoglobin, CK-MB and cardiac Troponin I 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.