MYO Rapid Test Kit One Step Cardiac Markers Myoglobin Cassette Card

One Step Cardiac Markers Rapid Test Kit Myoglobin Cassette Card

INTENDED USE
The Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
For professional in vitro diagnostic use only.
 
INTRODUCTION
Myoglobin (MYO) 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 with transporting oxygen within the muscle cells. 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.  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.
The Myoblobin Rapid Test Device is a simple test utilizing a combination of anti-Myoglobin antibody coated particles and capture reagent to detect Myoglobin in whole blood, serum or plasma. The minimum detection level is 50 ng/mL.
 
PRINCIPLE
The Myoblobin Rapid Test Device is a qualitative, membrane based immuno-assay for the detection of Myoglobin in whole blood, serum or plasma. The membrane is pre-coated with capture reagent on the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-Myoglobin antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with capture reagent on the membrane and generates a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
 
MAIN CONTENTS
• Rapid test Cassette with desiccant.
• Disposable pipettes.
• Buffer.
• Instructions for use.
 
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.
 
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.
 
OPERATION 
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 40mL) and start the timer. See illustration below.
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. See illustration below.
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. 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
POSITIVE:
Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE:
Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID:
Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
 
PERFORMANCE
The Myoblobin Rapid Test has been evaluated with a leading commercial Myoglobin EIA test using clinical specimens. The results show that the sensitivity of the Myoblobin Rapid Test is 99.99% and the specificity is 98.0% relative to the leading EIA test.
 
For detailed information, please contact Dewei person for Manual Instruction.