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Highly Sensitive Flourescence Immunoassay Test cassette for AMI Diagnosis

Brand Name:	ALLTEST Novatrend Plus
Model Number:	FI-HFA-402
MOQ:	N/A
Price:	negotiation

Detail Information

Product Description

Detail Information

Sensitivity:

High

Test Method:

Flourescence Immunoassay

Kit Size:

10/25T/kit

Time To Results:

15 Minutes

Intended Use:

For In Vitro Diagnostic Use

Certifications:

Test Range:

1-120 Ng/mL

Cut-off:

8 Ng/mL

Highlight:

mab antibodies

hybridoma Monoclonal antibodies

Product Description

The H-FABP Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence

Immunoassay to measure H-FABP in whole blood or plasma as an aid in the diagnosis

of acute myocardial infarction (AMI).

【SUMMARY】

FABP is a newly introduced plasma marker of acute myocardial infarction (AMI). The

plasma kinetics of FABP (15kD) closely resemble those of H-FABP in that elevated

plasma concentrations are found within 2 hours after AMI and return to normal generally

within 18 to 24 hours. But the concentration of FABP in the skeletal muscle is 20 times

lower than in cardiac tissue (for H-FABP the same content for cardiac and skeletal

tissue), that makes FABP to be more cardiac specific than H-FABP. This makes FABP a

useful biochemical marker for the early assessment or exclusion of AMI. FABP also

appears to be a useful plasma marker for the estimation of myocardial infarct size. FABP

is suitable for use as a standard in immunoassay for early detection of acute myocardial

infarction, immunogen for antisera production, mass FABP standard, FABP biochemical

and immunochemical studies, tracer for iodination.

【PRINCIPLE】

The H-FABP Test Cassette (Whole Blood/Serum/Plasma) detects Heart Type Fatty

Acid-Binding protein based on Fluorescence Immunoassay. The sample moves through

the strip from sample pad to absorbent pad. If the specimen contains H-FABP, it

attaches to the fluorescent microspheres-conjugated anti-H-FABP antibodies. Then the

complex will be captured by the capture antibodies coated on the nitrocellulose

membrane (Test line). The concentration of H-FABP 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 H-FABP in the sample

can be calculated by Analyzer to show H-FABP concentration in specimen.

【REAGENTS】

The test includes anti-H-FABP antibody coated fluorphores and anti-H-FABP 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 H-FABP Test Cassette should only be used with the

Analyzer by approved 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 1 day 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 (50ul of serum/plasma/75ul 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

10seconds 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 FIATEST GO Fluorescence Immunoassay Analyzer Operation Manual for the

complete instructions on use of the Test. The test should be conducted in room

temperature.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-

30°C) prior to testing.

1. Turn on the Analyzer power. Then according to the need, select “standard test” or

“Quick test” mode.

2. Take out the ID card and insert it into the Analyzer port.

3. Serum/Plasma: Pipette 50μl serum/plasma into the buffer tube, mix the specimen

and the buffer well.

4. Whole blood: Transfer 75μl whole blood into the buffer tube with pipette; mix the

specimen and the buffer well.

5. Add diluted specimen with a Pipette: Pipette 85μl diluted specimen into the

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

6. There are two test modes for FIATEST GO Fluorescence Immunoassay Analyzer,

Standard Test mode and Quick Test mode. Please refer to the user manual of FIATEST

GO Fluorescence Immunoassay Analyzer for details.

“Quick test” mode: After 15 minutes of adding sample,Insert the test cassette into the

Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST"

immediately. The Analyzer will automatically give the test result after a few seconds.

“Standard test” mode: Insert the test cassette into the Analyzer immediately after

adding specimen, click “STANDARD TEST”, fill the test information and click "NEW

TEST" at the same time, The Analyzer will automatically countdown 15 minutes. After

the countdown, the Analyzer will give the result at once.

【INTERPRETATION OF RESULTS】

Results read by Fluorescence Immunoassay Analyzer.

The result of tests for H-FABP 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 Analyze.

Linearity range of H-FABP Test is 1-120 ng/mL.

Reference range:＜8 ng/mL

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products details

Highly Sensitive Flourescence Immunoassay Test cassette for AMI Diagnosis

Highly Sensitive Flourescence Immunoassay Test cassette for AMI Diagnosis

mab antibodies

hybridoma Monoclonal antibodies