INTENDED USE

Heart Fatty Acid-Binding Protein (h-FABP) Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of h-FABP in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of myocardial infarction (MI).

INTRODUCTION

Heart-type fatty acid binding protein (h-FABP) is known as mammary-derived growth inhibitor is a protein that in humans is encoded by the FABP3 gene. Heart-type Fatty Acid-Binding Protein (H-FABP) is a small cytoplasmic protein (15 kDa) released from cardiac myocytes following an ischemic episode. Like the nine other distinct FABPs that have been identified, H-FABP is involved in active fatty acid metabolism where it transports fatty acids from the cell membrane to mitochondria for oxidation.

h-FABP is a sensitive biomarker for myocardial infarction and can be detected in the blood within one to three hours of the pain. The diagnostic potential of the biomarker H-FABP for heart injury was discovered in 1988 by Professor Jan Glatz (Maastricht, Netherlands) h-FABP is 20 times more specific to cardiac muscle than myoglobin, it is found at 10-fold lower levels in skeletal muscle than heart muscle and the amounts in the kidney, liver and small intestine are even lower again.

KIT COMPONENTS

PROCEDURE

Bring tests, specimens, buffer, 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. To obtain a best result, the assay should be performed within one hour.

2.Transfer 2 drops of serum or plasma to the specimen well of the device with a disposable pipette provided in the kit, and then start the timer.

OR

Transfer 2 drops of whole blood specimen to the specimen well of the device with a disposable pipette provided in the kit, then add 1 drop of buffer, and start the timer.

OR

Allow 2 hanging drops of fingerstick whole blood specimen to fall into the center of the specimen well (S) on the device, then add 1 drop of buffer, and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

As the test begins to work, you will see color move across the membrane.

3.Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

 NOTE:

1.The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.

2.Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.