Diagnostic Raw Materials

Raw materials for in vitro diagnostic reagents（IVD） refer to the raw materials of the reaction system used for biochemical, immunological or molecular diagnostic reagents, mainly referring to the core reaction system. The quality of upstream diagnostic reagent raw materials directly determines the quality of in vitro diagnostic products. According to the different nature, in vitro diagnostic reagent raw materials can be divided into antigen, antibody, enzyme and coenzyme, substrate and standard and other categories. Among them, the core reaction system raw materials such as antigen, antibody, diagnostic enzymes are the most important strategic nodes for in vitro diagnostic quality control, affecting the performance level of in vitro diagnostic reagents (e.g., sensitivity, stability), and are the main part of the composition of in vitro diagnostic reagents, of which antigen and antibody account for 45%, and enzymes and substrates account for 30%. 

Figure 1 In vitro diagnostic reagent raw materials for the heart

Raw materials for in vitro diagnostic reagents the application scenarios of different kinds of raw materials are also different.1. Antigen is the raw material for the preparation of antigenic in vitro diagnostic reagents, including prokaryotic/eukaryotic recombinant antigens, natural antigens and so on. Antigens are prepared by genetic engineering recombination technology, protein purification technology, cell biology technology and chemical synthesis technology, etc. They are suitable for infectious disease diagnosis, food safety diagnosis, digestive disease diagnosis and immune system disease diagnosis, etc. 2. Antibodies are the raw materials for the preparation of antibody-based in vitro diagnostic reagents, such as monoclonal antibodies and polyclonal antibodies, etc. Antibodies are the raw materials for the preparation of antibody-based in vitro diagnostic reagents, such as monoclonal antibodies and polyclonal antibodies. Antibodies are prepared by immunization technology, hybridoma cell technology, cell fermentation technology, etc., and are used for cardiovascular disease diagnosis, tumour diagnosis, infectious disease diagnosis, etc. Enzymes and coenzymes are the raw materials for the preparation of molecular diagnostic reagents such as fluorescence quantitative PCR (qPCR) and gene diagnostic reagents, immunodiagnostic reagents, and biochemical diagnostic reagents, which mainly include reverse transcriptase, DNA polymerase, alkaline phosphatase, horseradish Mainly include reverse transcriptase, DNA polymerase, alkaline phosphatase, horseradish peroxidase, etc. Enzymes and coenzymes are widely used in genetic testing, tumour diagnosis, infectious disease diagnosis, coagulation diagnosis, biochemical diagnosis of liver and renal function and other testing fields.4. Substrate provides a stable and necessary reaction environment for biochemical reactions, and it is an indispensable basic raw material for all kinds of in vitro diagnostics.5. Standard refers to the standard substances used for identification, examination, content determination, standard substances used for bioassay, content or potency determination of antibiotics or biochemical drugs. Standard substances for content or potency determination are calibrated by international standard and measured by potency unit or weight.

KMD Bioscience, as a supplier of in vitro diagnostic raw materials, has been supplying high-quality diagnostic antigens and antibodies to the IVD industry for several years, which are suitable for a variety of assay platforms, such as flow, colloidal gold, chemiluminescence, immunoturbidimetric assay, and so on. With four platforms, including monoclonal antibody preparation service platform, polyclonal antibody preparation service platform, phage antibody library technology platform, and antibody sequencing and application platform, we have been committed to the rapid development and large-scale production of proteins and antibodies for in vitro diagnostics. We can be used to diagnose bone metabolism, cardiovascular and cerebrovascular, tumour markers, glucose metabolism, nail function, gastric function, inflammation and other histocompatibility antigens. For example, Cardiac troponin I (CTnI) is a cardiac-specific regulatory protein that plays a key role in cardiac contraction by inhibiting the binding of myosin and Actin and mediating the relaxation of striated muscle. Mutations in its gene can cause familial hypertrophic cardiomyopathy type 7 (CMH7) and familial restrictive cardiomyopathy (RCM). cTnI is one of the most sensitive and specific serum markers of cardiomyocyte injury, and its level varies widely in the early stages of acute myocardial infarction (AMI).

KMD Bioscience's antibody diagnostic raw materials and antigen diagnostic raw materials strictly monitor each process during the R&D and production phases, and analyse the performance indexes (specificity, stability, etc.) of antibodies/antigens to ensure that IVD raw materials are characterised by small batch-to-batch/intra-batch variations, wide linear ranges, good stability, high sensitivity, and so on. KMD Bioscience can create tailor-made one-stop solutions according to the needs and application scenarios of corporate customers, fully supporting the development of in vitro diagnostic reagent products.

Product Line:

（1）Antibody diagnostic raw materials applied to colloidal gold, immunofluorescence, chemiluminescence, turbidimetric and other detection platforms:

Bone metabolism diagnostic materials:25-OH 

Cardiovascular:cTnI,cTnT,H-FABP,NT-proBNP,BNP,MYO,CKMB,ST2, etc.

Tumour markers:GP73,AFP,CEA,tPSA,CA242,CA72-4, etc.

Glucose metabolism: HbA1c, INS, C-P, etc.

Nail function: T3,T4, TSH, etc.

Gastric function: G-17, PGI, PGII, H.pylori, Hb, etc.

Lipid markers: ApoA1, ApoB, Lp(a), ApoE, etc.

Thrombotic markers: FM, FDP, D-Dimer, etc.

Inflammation: CRP, PCT, SAA, IL-6, HBP, etc.

Gonadal category:AMH,HCG,LH,FSH,Total/Free, etc.

（2）Antigenic diagnostic materials for quality control, calibration, and immunogens.

25-OH,cTnI,cTnT,H-FABP,NT-proBNP,BNP,MYO,CKMB,ST2,GP73,AFP,CEA,tPSA,CA242,CA72-4,HbA1c, INS, C-P,T3, T4, TSH,G-17, PGI,FDP,CRP, PCT, SAA, IL-6, HBP,AMH,HCG,LH,FSH.