In vitro diagnostic reagents: the quality of raw materials determines the finished product

Release time:

2020-08-29


In this year's new crown epidemic, whether it is nucleic acid testing reagents or antibody testing reagents, whether it is patient diagnosis or large-scale screening, IVD companies are playing a vital role. However, this market has always had both opportunities and challenges. For today's in vitro diagnostic reagent manufacturers, innovation, sensitivity, stable performance, and cost-effectiveness are more important than ever.

Therefore, it is necessary to find more efficient business partners to continuously improve the speed of research and development, production efficiency and quality stability. Essentially, we need a supplier with a complete product line, experienced, up-to-date, and reliable. In recent years, Desheng has been carrying out continuous R&D and innovation, from raw material preparation to strict control of every link of product production, which has brought customers a good product experience and is deeply favored by customers at home and abroad.

Antigens, antibodies and enzymes are the core raw materials for diagnosis. The characteristics of raw materials such as purity and activity will affect the sensitivity, specificity and stability of downstream detection. Therefore, its development, screening and quality control are the most important in the construction of in vitro diagnostic detection systems. The important link.

In clinical testing, if the purity of the raw materials is not enough, it will often interfere with the detection or even false positives. Therefore, optimizing the purification process to maximize the purity of the raw materials is of great significance to the quality of the raw materials and the quality of the kit. The diagnostic reagents developed by Desheng, such as chromogenic reagents, chemiluminescence reagents, and biological buffers, have a purity of over 99% and are all analytical reagents.

From the perspective of the entire immunodiagnostic reagent development process, the affinity of antibody raw materials is the key to product development. The traditional determination of affinity is by ELISA, which takes a long time and cannot obtain kinetic data, and kinetic data is particularly critical in raw material screening. Biacore innovatively uses SPR technology to obtain affinity and kinetic data while greatly improving the detection rate (6 times higher). The diagnostic raw materials usually need to be coupled to the use of markers, and the purification step after labeling can remove the labeled Separate antigen/antibody, free label and unlabeled antigen/antibody, effectively reducing interference.

Desheng is an established manufacturer specializing in the development and production of enzyme preparations and antigen antibodies. It has been making full use of its own R&D capabilities to provide customers with professional knowledge and technical support. Customers in need are welcome to consult and discuss.