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Flourescence Immunoassay Test cassette for Myoglobin Detection in Whole Blood/Serum/Plasma

Brand Name:	ALLTEST Novatrend Plus
Model Number:	FI-MYO-402
MOQ:	N/A
Price:	negotiation
Payment Terms:	Ex works

Detail Information

Product Description

Detail Information

Sensitivity:

High

Time To Results:

15 Minutes

Storage:

4-30°C

Sample Type:

Whole Blood, Serum, Plasma

Product Type:

Diagnostic Test Kits

Detection Method:

Fluorescence Immunoassay

Application:

In Vitro Diagnostics

Qualified:

Highlight:

mab antibodies

hybridoma Monoclonal antibodies

Product Description

The Myoglobin Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro quantitative

determination of Myoglobin in human 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 17.8 kDa. It constitutes about 2 percent of total muscle protein and is

responsible for 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

【PRINCIPLE】

The Myoglobin Test Cassette (Whole Blood/Serum/Plasma) detects Myoglobin based on

Fluorescence Immunoassay. The sample moves through the strip from sample pad to

absorbent pad. If the specimen contains Myoglobin, it attaches to the fluorescent

microspheres-conjugated anti-Myoglobin antibodies. Then the complex will be captured by the

capture antibodies coated on the nitrocellulose membrane (Test line). The concentration of

Myoglobin in the sample correlates with the fluorescence signal intensity captured on the T

line. According to the fluorescence intensity of the test and the standard curve, the

concentration of Myoglobin in the sample can be calculated by Analyzer to show Myoglobin

concentration in specimen.

【REAGENTS】

The test includes anti-Myoglobin antibody coated fluorophores and anti-Myoglobin antibody

coated on the membrane.

【PRECAUTIONS】

1. For professional in vitro diagnostic use only.

2. Do not use after the expiration date indicated on the package. Do not use the test if the foil

pouch is damaged. Do not reuse.

3. Avoid cross-contamination of specimens by using a new specimen collection container for

each specimen obtained.

4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle

all specimens as if they contain infectious agents. Observe established precautions against

microbiological hazards throughout the procedure and follow standard procedures for proper

disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves

and eye protection when specimens are assayed.

5. Do not interchange or mix reagents from different lots.

6. Humidity and temperature can adversely affect results.

7. Used testing materials should be discarded in accordance with local regulations.

8. Read the entire procedure carefully prior to any testing.

9. The Myoglobin Test Cassette should only be used with the analyzer by medical

professionals.

【STORAGE AND STABILITY】

1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed pouch.

2. The test must remain in the sealed pouch until use.

3. Do not freeze.

4. Care should be taken to protect the components of the kit from contamination. Do not use if

there is evidence of microbial contamination or precipitation. Biological contamination of

dispensing equipment, containers or reagents can lead to false results.

【SPECIMEN COLLECTION AND PREPARATION】

Preparation

Before performing the test, please make sure that all components are brought to room

temperature (15-30 °C). Cold buffer solution or moisture condensation on the membrane can

lead to invalid test results.

Sample Handling

1. Collect the specimen according to standard procedures.

2. Do not leave specimens at room temperature for prolonged periods. Serum/Plasma

specimens may be stored at 2-8 °C for up to 3 days, for long term storage, specimens

should be kept below -20 °C. Whole blood collected by venipuncture should be stored at 2-

8 °C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens.

Whole blood collected by finger stick should be tested immediately.

3. Bring specimens to room temperature prior to testing. Frozen specimens must be

completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of

specimens.

4. EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as the

anticoagulant for collecting the specimen.

Sample Dilution / Sample Stability

1. The specimen (50 μL of serum / plasma / 75 μL of whole blood) can be added directly

with the micro pipette into the buffer.

2. Close the tube and shake the sample by hand vigorously for approximately 10 seconds to

mix the sample and dilution buffer.

3. Let the diluted sample homogenize for approximately 1 minute.

4. It is best to place the diluted sample on an ice pack and leave the sample at room

temperature for no more than 8 hours.

【MATERIALS】

Materials Provided

• Test Cassettes

• Specimen Collection Tubes with Extraction Buffer

• ID Card

• Package Insert

Materials Required But Not Provided

• Timer

• Centrifuge

• Fluorescence Immunoassay Analyzer

• Pipette

• Specimen Collection Containers

【DIRECTIONS FOR USE】

Refer to Fluorescence Immunoassay Analyzer User Operation Manual for the complete

instructions for the use of the analyzer. The test should be conducted at room temperature.

Allow the test, specimen and buffer to reach room temperature (15-30 °C) prior to

testing.

1. Turn on the Analyzer power.

2. Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or sample

type according to needs.

3. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best

results will be obtained if the assay is performed immediately after opening the foil pouch.

4. Place the test on a flat and clean surface.

Serum/Plasma: Pipette 50μL of serum/plasma into the buffer tube; mix the specimen and

the buffer well.

Whole blood: Transfer 75μL of whole blood into the buffer tube with pipette; mix the

specimen and the buffer well.

5. Add diluted specimen with a Pipette: Pipette 85μL of diluted specimen into the sample

well of the test cassette. Start the timer at the same time.

6. Test results should be interpreted at 15 minutes with the use of Fluorescence

Immunoassay Analyzer.

Caution: There are different test modes of the Fluorescence Immunoassay Analyzer. The

difference between them is incubation of the test cassette is outside or inside the analyzer.

Choose test mode accordingly and confirm sample type. Consult the user manual of the

analyzer for detailed operation information.

Operator must consult the Fluorescence Immunoassay Analyzer User Manual prior to use and

become familiar with the processes and quality control procedures.

【INTERPRETATION OF RESULTS】

Results read by Fluorescence Immunoassay Analyzer.

The result of tests for Myoglobin is calculated by Fluorescence Immunoassay Analyzer and

display the result on the screen. For additional information, please refer to the user manual of

Fluorescence Immunoassay Analyzer.

Linearity range of Myoglobin Test is 5~200 ng/mL.

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products details

Flourescence Immunoassay Test cassette for Myoglobin Detection in Whole Blood/Serum/Plasma

Flourescence Immunoassay Test cassette for Myoglobin Detection in Whole Blood/Serum/Plasma

mab antibodies

hybridoma Monoclonal antibodies