【INTENDED USE】

The H-FABP Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human H-FABP in whole blood,serum or plasma as an aid in the diagnosis of acute myocardial infarction (AMI).

【SUMMARY】

Heart-type  fatty  acid  binding  protein (H-FABP)  also  known  as mammary-derived  growth inhibitor is a protein that in humans is encoded by the FABP3 gene.[1]  Heart-type Fatty Acid-

Binding Protein (H-FABP) is a small cytoplasmic protein (15kDa) released from cardiac myocytes following an ischemic episode.[2] 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.[2]

H-FABP is recommended to be measured with troponin to identify myocardial infarction and acute coronary syndrome in patients presenting with chest pain H-FABP measured with troponin shows increased sensitivity of 20.6% over troponin at 3–6 hours following chest pain onset.[3]

The H-FABP Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-H-FABP antibody coated particles and capture reagent to detect H-FABP in whole blood, serum or plasma.The minimum detection level is 5.0ng/mL.

【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 device from the sealed pouch and use it within one hour.

2. Place the Device on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50μl) to the specimen area,then add 1 drop of buffer (approximately 40μl),and start the timer.See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75μl) to the specimen area,then add 1 drop of buffer (approximately 40μl),and start the timer.See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube:Fill the capillary tube and transfer approximately 75μl of fingerstick whole blood specimen to the specimen area of test device,then add 1 drop of buffer (approximately 40μl) 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.