EBS Rapid Tests: Research and Development

The rapid test incorporates both immunoassay techniques and chromatography principles by fixing highly specific antibodies and antigens onto a nitrocellulose membrane. Colloidal gold nano-particles are used to determine the presence of antibodies or antigens.

A. Preparation of Colloidal Gold :

Colloidal gold particles are the most widely used coloration agent with the following advantages :

a. Convenient conjugation process, b. After synthesis, particles can be easily dispersed, c. Conjugation of colloidal gold and antibodies/antigen are highly stable

With a specialized chemical technique in producing the colloidal gold nano-particles, EBS is able to obtain a specific size and quality of particles. Through diligent research, the most suitable antibodies and antigens along with optimized parameters allowed EBS to develop a stable end-product.

 

B. Research and Develop of Rapid Test  :

The EBS R&D team developing the rapid test has diligently studied the principles of immunoassay techniques specifically relating to antibodies and antigens. Many different types of lateral immunochromatographic tests were researched, including “Direct”, “Indirect”, and “Competitive”, allowing us to select the most appropriate format for the specific rapid test kit.

 

C. Validation and Quality Control :

We validated the performance of the rapid test and tested repeatedly throughout the R&D stages to ensure the quality of the product. Multiple validation tests were performed and recorded resulting is the development of an effective, stable, and convenient product.

a. Interference test: Predicting and testing possible situations that may be encountered in the field relating to chemicals agents to ensure the performance and stability is not obstructed. b. Acceleration and Stability test: Testing the relationship between temperature and storage time on product performance and consistency, to confirm stability and shelf-life of rapid test kits.

Production of antibodies and antigens:

(gene library→selection→antigen→antibody)

To develop different types of rapid test products and to obtain high-quality raw materials, it is crucial to develop a production technology for our antibodies and antigens. Therefore the antigen specifications can meet the needs of each specific product.
The procedure is as follows :

1. Designed recombinant protein based on the principle of molecular biology. 2. Searched precise genome sequences through online gene data base. 3. Expressed recombinant protein through transgenic technology by cloning target gene onto the specific cell.

The complete recombinant protein purification platform was built on several purification methods, such as precipitation, gel chromatography, ion exchange chromatography, and affinity chromatography, thus increasing protein purity and availability. This platform has also been applied in the development of mono-clonal and poly-clonal antibodies.

ELISA: Research and Development

ELISA (enzyme-linked immunosorbent assay) technology was developed according to the principle of RIA (radio immunoassay). In the presence or detection of the particular enzyme, the related antibody and antigen are bound together and resulting in a reaction. Concentration levels are interpreted by intensity of the color appearing in the wells.

The ELISA technology can be used for many different purposes. Hence, different prototypes are used – direct, indirect, or competitive. Every probable antibody or antigen are examined and selected during the early stages of product development in order to determine the most appropriate materials.

The purified target antibody or antigen is conjugated with enzymes for the further development or production. The entire process is verified and put through a strict quality control to ensure performance and stability of the ELISA kits.