A rapid test for the diagnosis of myocardial infarction (MI) to detect qualitatively CE certified
The Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myogobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Myoglobin (MYO) is a heme-protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8kDa.It constitutes about 2 percent of total muscle protein and is responsible with transporting oxygen within the muscle cells.1 When the muscle cells are damaged, Myoglobin is released to the blood rapidly due to its relatively small size. Following the death of tissue associated with MI, Myoglobin is one of the first markers to rise above normal levels. 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 A number of reports suggest the measurement of Myoglobin as a diagnostic aid in confirming the absence of myocardial infarction with negative predictive values of up to 100% reported at certain time periods after onset of symptoms.4
The Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-Myoglobin antibody coated particles and capture reagents to qualitatively detect Myoglobin in whole blood, serum or plasma. The minimum detection level is 50ng/mL.
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 within one hour.
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 50µL) to the specimen area, then add 1 drop of buffer (approximately 40µL), and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
· Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75µL) to the specimen area, then add 1 drop of buffer (approximately 40µL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 75µL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40µL) and start the timer. See illustration below.
· To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75µL) to fall into the specimen area of test cassette, 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 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 colored line in the test line region indicates a positive result. This indicates that the concentration of Myoglobin is above the minimum detection level.
*NOTE: The intensity of the color in the test line region will vary depending on the concentration of Myoglobin, present in the specimen. Therefore, any shade of color in the test line region 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 Myoglobin is below the minimum detection level.
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.