| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P |
| Certificate | CE |
| Reading Time | 10 minutes |
| Pack | 10 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | >99.9 |
| Specificity | 97.20% |
| Accuracy | 97.50% |
| Cut-Off | 35-600 ng/mL |
Myoglobin Rapid Test Cassette, performed with the LF
Reader,semi-quantitative
A rapid test for the diagnosis of myocardial infarction (MI) to
detect Myoglobin qualitatively in whole blood, serum or plasma. For professional in vitro diagnostic
use only.
INTENDED USE
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).
SUMMARY
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.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 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.
PRINCIPLE
The Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) is a
qualitative, membrane based immunoassay for the detection of Myoglobin in whole blood,
serum or plasma. The membrane is pre-coated with specific capture antibodies in the test
line region of the test.
During testing, the whole blood, serum or plasma specimen reacts
with the particle coated with specific antibodies. The mixture migrates upward on the membrane
chromatographically by capillary action to react with specific capture reagents on the
membrane and generate a colored line. The presence of this colored line in the specific
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.
REAGENTS
The test contains anti-Myoglobin antibody conjugated colloid gold
particles and capture reagents coated on the membrane.
PRECAUTIONS
- For professional in vitro diagnostic use only. Do not use
after expiration date.
- Do not eat, drink or smoke in the area where the specimens or
kits are handled.
- Do not use test if pouch is damaged.
- Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards throughout all
procedures and follow the standard procedures for proper disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
- The used test should be discarded according to local
regulations.
- Humidity and temperature can adversely affect results.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or
refrigerated (2-30°C). The test is stable through the expiration date printed on the
sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use
after the expiration date.
DIRECTIONS FOR 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 50uL) to the specimen area, then add 1 drop of buffer (approximately 40uL),
and start the timer.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 3 drops of whole blood
(approximately 75 uL) to the specimen area, then add 1 drop of buffer (approximately 40
uL), and start the timer.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer
approximately 75 uL of fingerstick whole blood specimen to the specimen area of test
cassette, then add 1 drop of buffer (approximately 40 uL) and start the timer. See
illustration below.
To use hanging drops: Allow 3 hanging drops of fingerstick whole
blood specimen (approximately 75uL) to fall into the specimen area of test
cassette, then add 1 drop of buffer (approximately 40 uL) 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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| CMY-R402 | Myoglobin Rapid Test Cassette | WB/S/P | 10T |
