Assay Development Questionnaire

     Immunochemistry Technologies is a custom service laboratory specializing in immunoassay development and manufacturing.  If you need to detect or measure a specific target molecule, we can fully develop a quick and accurate immunoassay test (or optimize an existing assay) according to your specifications. 
     In order to assess the feasibility of your project and generate an accurate quote, here are some questions we would typically ask you.  You may print out the questions and fax us your answers at 952-888-8988 or simply give us a call at 1-800-829-3194 and we can go through it together.  You don't have to answer all of the questions.   

1. How will the assay be used?
2. What is the specific analyte that you want to measure?
3. What are the characteristics of the analyte?
   1. Amount of purified analyte available?
   2. Molecular weight?
   3. If the analyte is a small compound or peptide, what is the structure or amino acid sequence?
   4. Is the analyte an infectious biological agent (virus, bacteria)?
   5. Are there any general toxicity issues associated with the handling or use of the analyte as an immunogen in animals?
   6. Isoelectric focusing point (pI)?
   7. Extinction coefficient?
   8. Is the analyte acid labile?
   9. Storage buffer (including pH)?
   10. Solubility?
   11. Storage conditions?
   12. If analyte is lyophilized, what stabilizers were used?
4. What is the matrix of the sample to be tested (such as blood, water, tissue culture supernatants, etc.)?
5. Does the sample have to be pre-treated, such as extractions or centrifugations? If yes, what are they?
6. What is the expected concentration and range of the analyte in the sample?
7. Are there any cross-reacting or interfering substances in the sample that may affect the assay (such as rheumatoid factors, or an analog)?
8. Are there any polyclonal antibodies available?
   1. If so, from what species (rabbit, goat, etc.)?
   2. What format is it in (whole serum, lyophilized, etc.)?
   3. Has it been purified by Protein G or any other way?
   4. Has it been affinity purified?
   5. How much is available?
   6. What is the concentration in mg/mL of total antibody or specific antibody?
9. Are there any monoclonal antibodies available?
   1. What format is it in (ascites, cell culture supernatant, whole serum, lyophilized, etc.)?
   2. Has it been purified by Protein A or any other way?
   3. How much is available?
   4. What is the concentration in mg/mL of total antibody or specific antibody?
10. Is the assay for a one-time project, or will it be used for routine and on-going testing?
    1. How many samples will be tested overall?
    2. How many samples will be tested at one time?
11. Where will the assay be used (in the lab or in the field)?
12. Who will be running the assay (experienced scientists or non-technical people)?
13. Do you have a microtiter plate reader or other instrument for reading the test?
14. Does your test require FDA approval (or will it in the future)?
15. Do you need GMP documentation?
16. Is there any other information that may affect the design of the assay that you know of?

Need to detect a molecule? 

Call us 800-829-3194