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

Individually packed test devices	Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions.
Disposable pipettes	For adding specimens use.
Buffer	2 mL/vial. Phosphate buffered saline and preservative.
Package insert	For operation instruction.

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.

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.