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Cardiac Markers Combo Rapid Test is a device for rapid visual immunoassay for the qualitative presumptive detection of human cardiac Troponin I, Myoglobin, and CK-MB in the whole blood, serum or plasma. This kit is intended to be used as an aid in the diagnosis of myocardial infarction (MI).
Creatine Kinase MB (CK-MB), Myoglobin (MYO), and cardiac Troponin I (cTnI) are proteins that are released into the bloodstream after the cardiac injury. Myoglobin is a heme-protein that is normally found in the skeletal and cardiac muscle and has a molecular weight of 17.8 kDa. It constitutes about 2 percent of the total muscle protein and is responsible for transporting oxygen within the muscle cells. When these cells are damaged, Myoglobin is released into the blood rapidly. The level of Myoglobin increases measurably above the baseline within 2 to 4 hours post-infarct, peak at 9 to 12 hours, and return to baseline within 24 to 36 hours.
CKMB is an enzyme that is also present in the cardiac muscle and has a molecular weight of 87.0 kDa. Creatine Kinase is a dimeric molecule that is formed from two subunits designated as “M” and “B” that combine to form 3 different isoenzymes, CKMM, CKBB, and CKMB. CKMB is the iso-enzyme of Creatine Kinase, which is mostly involved in the metabolism of cardiac muscle tissue. The release of CKMB into the blood following an MI can be detected within 3 to 8 hours after the onset of symptoms. It peaks within 9 to 30 hours and returns to its baseline level within 48 to 72 hours.
Cardiac Troponin I is a protein that is found in the cardiac muscle and has a molecular weight of 22.5 kDa. It is a part of a three subunit complex comprised of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component, which helps in regulating the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle. After the cardiac injury, Troponin I is released into the blood 4 to 6 hours after the onset of pain. The release the pattern of Troponin I is similar to CKMB, but as CKMB levels return to normal after 72 hours, Troponin I remains elevated for 6 to 10 days, thus provide a longer window of detection for cardiac injury.
REAGENTS AND MATERIALS SUPPLIED
This test kit contains the following components to perform the assay:
Test device cassette
Instructions for use
Specimen Collection Straw/Capillary
Fresh serum or plasma samples can be used for the test. No special patient preparation is required, care should be taken to ensure full clotted blood and any visible particulate matter in the sample should be removed by centrifugation or filtration. Avoid the use of a high hemolytic, microorganism, turbid contaminated samples. Samples can be stored for over 30 days at 2 to 8°C.
Samples are not required for the assay for 3 days and should be stored frozen at -20°C or lower. Avoid the sample deterioration by multiple freeze-thaw cycles.
Plasma: Collect the whole blood in a collection tube, containing EDTA, citrate or heparin, respectively by venipuncture. Then separate the plasma by centrifugation.
Serum: Collect the whole blood into a collection tube, containing no anticoagulants by venipuncture. Then allow the blood to clot and separate by centrifugation.
The samples cannot be tested directly and must be diluted with sample diluents before testing.
Allow the test kit, specimen and/or controls to come to room temperature (15 to 30°C) prior to testing.
Remove the test kit form the sealed pouch and use as soon as possible
Arrows point towards the specimen, immerse the strip test vertically in the specimen for at least 5 seconds. Do not pass the maximum line on the strip while immersing it
Keep the strip flat on a non-absorbent clean surface and start the timer and wait for the red line(s) to appear. Read the result within 5 minutes but not longer than 15 minutes.
INTERPRETATION OF RESULTS
Negative: When only one colored band is visible on the control (C) region and no apparent band on the test (T) region.
Positive: In addition to a pink colored control (C) band, a distinct visible pink colored band appears in the test (T) region.
Invalid: Total absence of color in both the regions indicates procedure error and/or the test reagent has deteriorated.