Test Parameter: | Human Cardiac H-FABP | Intend Use: | Evaluation Of Acute Myocardial Infarction (AMI) |
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Package: | 25pcs/box, 20pcs/box | Storage: | Room Temperature 4-30℃ |
Sample: | Whole Blood/Serum/Plasma | Principle: | Immunochromatography |
Test Result: | Positive Or Negative | Result Time: | Read In 10 Mins |
High Light: | AMI Rapid Test Cassette,H-FABP Rapid Test Cassette |
INTENDED USE
h-FABP Rapid Test is intended for the qualitative determination of cardiac FABP in human whole blood. Measurement of FABP values is useful in the evaluation of acute myocardial infarction (AMI).
INTRODUCTION
The human cardiac FABP (H-FABP or FABP3) is a 132 amino acid small molecular weight (15kDa) protein (1). H-FABP is one of the most abundant proteins in cardiomyocytes and is mainly involved in fatty acid transport (2). The concentration of fatty acids in plasma and in myocardial tissue rise during myocardial ischemia acting to protect myocytes against fatty acid oxidation (3-7). Upon acute myocardial infarction (AMI) the blood and urine levels of H-FABP rise rapidly (8-10) (within 1-3 hours) reaching their peak values at 6 hours, and return to baseline concentration within 24 hours. Characteristics of H-FABP appear to be similar to those of myoglobin (11-14), however, H-FABP concentrations are 2–10-fold higher in the heart than in the skeletal muscle (15, 16). In contrast, myoglobin concentrations are 2-fold lower in cardiac cells than skeletal cells. Thus, the apparent greater cardiospecificity of H-FABP, along with certain aspects of its biology account for its greater value in diagnostics of AMI (16-20).
PRINCIPLE
The H-FABP Rapid Test (Whole blood/Serum/Plasma) detects H-FABP through visual interpretation of color development in the internal strip. Anti- H-FABP antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti- H-FABP antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient H-FABP in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the 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.
SAMPLE COLLECTION
1. The H-FABP Rapid Test Kit is intended for use with human whole blood, serum, or plasma specimens only.
2. Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
3. Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and 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 fingerstick should be tested immediately.
4. Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
5. 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.
6. If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
OPERATION
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
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 3 drops of whole blood/serum/plasma to the specimen well (S) of the device with the provided disposable pipette, and start the timer.
OR
Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and start the timer.Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3) If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).
4) Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
PERFORMANCE
Sensitivity: The minimum detectable concentration of H-FABP Rapid Test Device is 10 ng/ml.
Cross-Reactivity: Sera containing known amounts of FABP4 (≤10000 ng/ml), and cardiac Troponin I (≤5000 ng/ml) have been tested with the device. No cross-reactivity was observed.
For detailed information, pls contact Dewei person for instruction manual.