Home > Service > Antibody related bioassay and kit development
 
For many years, immunoassays/diagnostic kits have been used in hospitals, laboratory medicine, and research to identify and assess the progression of disease. Information gained by clinical immunoassay testing has led to improved therapeutic choices. In research laboratories, immunoassays are used in the study of biological systems by tracking different proteins, hormones, and antibodies. In industry, immunoassays are used to detect contaminants in food and water. Antagene Inc is a custom service company specializing in antibody production, immunoassay development and kit manufacturing.  The scientists at Antagene Inc have the knowledge and expertise to develop reliable, sensitive, and specific immunoassays.  Antagene Inc can develop immunoassays:

           for immunogenicity studies to detect IgG, IgE, IgM, and other molecules to   
            measure the immune response to a specific drug or targeted proteins.
           to measure proteins and peptides found in serum, plasma, urine, and cell
            culture fluids for research or diagnostic purpose.
           to measure enzymes used in food processing and industrial applications for
            precise quality control.

If you need to detect a specific target protein or drug, we can fully develop immunoassay test (or optimize an existing assay) according to your specifications. Once developed, we will ship the components to you, and all products associated with the project shall become the exclusive property of yours at the conclusion of the project. Full confidentiality is guaranteed.  For more details regarding our bioassay and kit development services, please visit our service detail

So how can Antagene help you on your immunoassay development?

1. Read the information on our website. 
2. Contact us to briefly discuss your project and determine how our capabilities can meet   
   your needs.
3. Request a confidentiality agreement if you need. Review, sign, and send it back to us, or
   send us your confidentiality agreement for us to review.
4. Discuss the project with us in further detail so we can prepare a reliable quote.
5. Accept the quote, pay the front fee, and we will get started as soon as possible


The cost and time frame?

If the client provide target analyte and necessary antibodies, assay development generally costs between $10,000 - $15,000 and usually takes 2-4 months.
If antibodies are not available for use in the kit, it will take an additional 3-6 months to generate antibodies (both monoclonal and polyclonal antibodies) with additional cost of $6,000 - $8,000 and if antigen is not available, the cloning and expression of the antigen may take an additional 2-3 months with the additional cost of $3,000 - $5,000.

Free consultation

If you have questions with any immunochemistry project, Antagene Inc can help you by offering our scientific expertise as consultants.  Through our extensive experience in immunoassay development, we can provide current information and important insights into assay methodologies and related immunochemistry topics.




Service Detail

we are pleased to offer the following services

1. Monoclonal and Polyclonal Sandwich Immunoassay

     In a typical ELISA sandwich immunoassay, a monoclonal antibody is adsorbed onto a plastic microtiter plate. When the test sample is added to the plate, the antibody on the plate will bind the target antigen from the sample, and retain it in the plate. When a polyclonal antibody is added in the next step, it also binds to the target antigen (already bound to the monoclonal antibody on the plate), thereby forming an antigen sandwich between the two different antibodies.
     This binding reaction can then be measured by enzymes in an enzyme immunoassay format (EIA or ELISA) attached to the polyclonal antibody. The enzyme generates a color signal proportional to the amount of target antigen present in the original sample added to the plate. The degree of color can be detected and measured with the naked eye (as with a home pregnancy test), or with a spectrophotometric plate reader (for an EIA). 

     Step 1
: Monoclonal antibodies adsorbed onto the well of a plastic microtiter plate. 
     Step 2: Addition of a sample (such as human blood) added to the well of the plate, with  
                binding of the target antigen to the antibody already bound to the plate.
     Step 3: Binding of a polyclonal antibody to the target antigen, thereby forming an antigen 
                sandwich between the two different antibodies. The enzymes on the polyclonal
                antibodies will generate a color signal proportional to the amount of target  
                antigen present in the original sample added to the plate.


2. Antigen-Coated Immunoassay

     In an antigen-coated immunoassay, the analyte is coated onto a 96-well microtiter plate and used to bind antibodies found in a sample.  When the sample is added (such as human serum), the antigen on the plate is bound by antibodies from the sample.  A species-specific antibody  labeled with HRP is added next, which, binds to the antibody bound to the antigen on the plate.  The antigen-coated immunoassay are often used to diagnose allergy conditions - usually, a patient's blood is tested against different allergens to see if the person has antibodies to that allergen. 

3. Competitive Inhibition Immunoassay

    Competitive inhibition assays are usually used to measure small analytes because competitive inhibition assays only require the binding of 1 antibody rather than 2 as is used in standard ELISA formats.  Therefore, in a competitive inhibition assay, the sample and conjugated analyte are added in steps like a sandwich assay, while in a classic competitive inhibition assay, these reagents are incubated together at the same time. 
     In a sequential competitive inhibition assay format, a monoclonal antibody is coated onto a 96-well microtiter plate.  When the sample is added, the MoAb captures free analyte out of the sample. In the next step, a known amount of analyte labeled with either biotin or HRP is added.  The labeled analyte will then also attempt to bind to the MoAb adsorbed onto the plate, however, the labeled analyte is inhibited from binding to the MoAb by the presence of previously bound analyte from the sample. This means that the labeled analyte will not be bound by the monoclonal on the plate if the monoclonal has already bound unlabeled analyte from the sample.
     The amount of unlabeled analyte in the sample is inversely proportional to the signal generated by the labeled analyte. The lower the signal, the more unlabeled analyte there is in the sample.  A standard curve can be constructed using serial dilutions of an unlabeled analyte standard.  Subsequent sample values can then be read off the standard curve as is done in the sandwich ELISA formats. 
      Detection of labeled analyte may be made by using a peroxidase substrate such as TMB, which can be read on a microtiter plate reader

4. One Step rapid Immunoassay


    With one step immunoassay, the antibody and antigen reagents are bound to porous membranes, which react with positive samples while channeling excess fluids to a non-reactive part of the membrane.
     One step immunoassays commonly come in 2 configurations: a lateral flow test where the sample is simply placed in a well and the results are read immediately; and a flow through system, which requires placing the sample in a well, washing the well, and then finally adding an analyte-colloidal gold conjugate and the result is read after a few minutes. One sample is tested per strip or cassette.
     Because rapid tests are faster than microtiter plate assays, require little sample processing, are often cheaper, and generate yes/no answers without using an instrument, they often used in the field by non-laboratory people testing whole samples. However, one step rapid immunoassays are not as sensitive nor can they be used to accurately quantitate an analyte.


Sample Proposals and Typical Protocols

     Proposals are often broken down into 4 steps, which detail time and cost estimates (see the sample proposals listed here).  Payments are often structured with a front fee of 30% of the estimated total, and milestone payments disbursed thereafter, which can be paid after each step or monthly.  For examples of pricing and time-lines for assay development, click to see the following sample proposals:

Samples:
1. Microtiter Plate Antibody-Sandwich Sample Proposals
2. Microtiter Plate Antigen Coated Sample Proposals
3. Microtiter Plate Competitive Inhibition Sample Proposals
4. One Step Test Sample Proposals
  Typical Components of an Sandwich Immunoassay
  Typical Immunoassay Protocol

Please contact us for a quotation of your customized Antibody related Bioassay and kit  development project at:

                                    
 
 
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