MYO Rapid Test Cassette Myoglobin Blood Rapid Qualitative Test

MYO Rapid Test Cassette

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.

MAIN CONTENTS
• Rapid test Cassette with desiccant
• Disposable pipettes
• Buffer
• Instructions

CUT OFF
50 ng/mL

MYO 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.

MYO TEST OPERATION

Allow the test, specimen and/or controls to reach room temperature (15- 30°C) prior to testing.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.

2. Transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.

3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Do not interpret the result after 20 minutes.

MYO TEST RESULT 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:
The 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.

 
MYO TEST DETAILED PICTURE