The in vitro diagnostic industry is divided into upstream, midstream, and downstream industries. The upstream industry is the core raw material for in vitro diagnostic reagents, mainly providing basic raw materials for midstream in vitro diagnostic reagent production enterprises, such as enzymes, coenzymes, substrates, antigen antibodies, magnetic beads, microspheres, etc. It belongs to the field of basic materials science. IVD raw materials are located upstream in the entire industry chain, and their quality determines the quality of in vitro diagnostic reagents and the accuracy of diagnostic results, making them one of the core links in the industry chain. At present, the field is dominated by overseas brand products, and the domestic in vitro diagnostic raw material industry is still in its infancy.

 

Pyruvate kinase

 

IVD reagent raw material subdivision field

 

1. Core reaction system raw materials

 

(1) Antigens and antibodies: Antigens and antibodies are important raw materials for preparing immunodiagnostic reagents. Antigens include recombinant antigens, antigens, etc., which are prepared by genetic engineering recombinant technology, protein purification technology, cell biology technology, and chemical synthesis technology; Antibodies include monoclonal antibodies and polyclonal antibodies, which are prepared by immune technology, hybridoma cell technology, cell fermentation technology, and other methods. Antigen antibody reactions have characteristics such as specificity, reversibility, and sensitivity, and are widely used in diagnostic reagents based on immune reactions. These properties are also important indicators for reagent manufacturers to consider the performance of raw materials.

 

(2) Diagnostic enzymes: Enzymes are the core raw materials for biochemical and molecular diagnostics, and are also essential components of the enzyme substrate signaling system in immunodiagnosis. In biochemical diagnosis, different enzymes can catalyze specific biochemical reactions to help detect the levels of various substances in the body, such as glucose oxidase used for detecting blood sugar. Molecular diagnostic enzymes are essential raw materials for molecular diagnostic technologies such as polymerase chain reaction (PCR), nucleic acid hybridization technology, and biochar technology, including various hot start polymerases, conventional polymerases, reverse transcriptase, one-step reagents, and a complete set of enzymes for sequencing.

 

2. Signal system raw materials

 

(1) Colloidal gold: Colloidal gold is widely used in immunochromatographic techniques, such as common early pregnancy testing strips. It has high electron density and can produce significant color changes under specific wavelengths of light when combined with biomolecules such as proteins, thereby achieving visual detection of target substances.

 

(2) Enzyme substrate system: In detection methods such as enzyme-linked immunosorbent assay (ELISA), enzymes act on substrates to produce color changes or luminescent signals. The substrate of horseradish peroxidase (HRP), tetramethylbenzidine (TMB), undergoes a color change when catalyzed by HRP, and the content of the analyte can be determined by the intensity of the color.

 

(3) Fluorescent/luminescent substances: Chemical luminescent substances such as acridine esters can release photons during chemical reactions, producing detectable luminescent signals. In chemiluminescence immunoassay, acridine ester labels antigens or antibodies, reacts with the analyte in the sample, and achieves quantitative analysis of the analyte by detecting the luminescence intensity.

 

3. Reaction system carrier raw materials

 

(1) NC membrane: also known as nitrocellulose membrane, used as a solid carrier in immunochromatographic test strips to immobilize bioactive substances such as antigens and antibodies. The test substance in the sample undergoes an immune reaction with a fixed bioactive substance on the NC membrane, and the result is determined by observing the color development of the detection line and control line.

 

(2) Enzyme linked immunosorbent assay (ELISA) plate: usually made of polystyrene material, with good adsorption performance on the surface, can be used to adsorb antigens, antibodies, etc.

 

(3) Magnetic beads and microspheres: Magnetic beads and microspheres can serve as carriers for immune reactions and play a role in magnetic or optical detection systems.

 

(TAPS buffer raw material)

 

Upstream manufacturer Hubei Xindesheng's business in the field of IVD reagent raw materials

 

1. Raw materials for blood pre-treatment reagents

 

Desheng produces coagulants, anticoagulants, serum separation gels, silicification agents and other products, such as heparin lithium, with a potency of ≥ 150IU per milligram. It has ISO-9001 quality management system certification and has been sold to multiple regions. Anticoagulants play a crucial role in blood sample collection and preservation, preventing blood clotting and ensuring smooth subsequent testing. Blood clotting agents, blood clotting powders, and other products can accelerate the process of blood coagulation, enabling faster separation of serum or plasma and improving detection efficiency.

 

2. Blood diagnostic reagent materials

 

(1) Chromogenic substrate: can undergo colorimetric reactions with corresponding enzymes or other substances, used in fields such as biochemical diagnosis, to help detect the content of specific substances in samples.

 

(2) Chemiluminescence reagents: play an important role in chemiluminescence immunoassay, such as the company's deep cultivation in the field of direct chemiluminescence of acridine esters, and its Desheng brand acridine ester products have won a good reputation in the market.

 

(3) Enzyme preparations: As one of the core raw materials for biochemical and molecular diagnostics, Desheng's enzyme preparations can be used in the production of various diagnostic reagents.

 

Hubei Xindesheng Company has been involved in multiple sub sectors of IVD reagent raw materials. Through continuous research and development, production, and market expansion, it has provided raw material products to numerous domestic and foreign enterprises, gradually emerging in the industry. If you have any purchasing needs, please feel free to contact us at any time!