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Immunoassays 2008: An End-User Survey Exploring Current Trends and Future

Biocompare
May 1, 2008
74 Pages - SKU: BCOM1899672

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Report Overview

The 2008 Immunoassay Report is composed of an immunoassay technology overview and an introduction to the 2008 Immunoassay Survey, containing questions about the use of immunoas¬says and supplier information, as well as purchasing trends in this research area. The report also includes a comprehensive discussion of the survey results and conclusions and recommendations drawn from both an immunoassay technology analysis and the survey data.

The technology over¬view delves into the science behind the basic chemistry involved in immunoassays, describing the advances and limitations of this technology. The shift of much of basic research into proteomics and the increased demand for reagents, kits, and instruments in molecular analysis are key to the growth of this research area. Citing the immense potential of clinical diagnostics, the market for immunoassays has tremendous growth possibilities. Driven by high-throughput applications and the need for miniaturization, immunoassays have expanded the number of pertinent targets and detection methodologies available. Bead-based protocols have also contributed to the increase in the widespread use of immunoassays, furthering growth in such areas as molecular diagnostics. Biomarker development, another growing research area, plays into the immunoassay application market as well. With more researchers looking to increase the number of samples analyzed using this technology in the coming year, despite a difficult economic environment, the future bodes well for immunoassay suppliers across the biotechnology and life science industries.

Technology Overview

Immunoassay technologies are used for the identification and quantitation of specific analytes, using antibodies that bind a target compound or class of compounds. Concentrations of analytes are detected by sensitive reactions that can be colorimetric, fluorescent, radioactive, or chemilu¬minescent. A determination of the target analyte’s presence and concentration is made by com¬parison with a standard containing the analyte at a known concentration. Concentration can be estimated roughly by the naked eye or can be determined more accurately with a photometer or spectrophotometer.

Immunoassays exploit the ability of antibodies to bind selectively to a target analyte that has a specific physical structure present in a sample matrix. Working much like a key and lock, the binding sites on an antibody attach precisely and non-covalently to their corresponding target. Because binding is based on the analyte’s physical shape rather than its chemical properties, anti¬bodies will not respond to substances that have dissimilar structures. Enzyme-linked immunosor¬bent assays (ELISA) are most commonly used because the technology can be optimized for speed, sensitivity, and selectivity; ELISAs have long shelf lives and are simple to use. In an ELISA, antibodies are developed specifically to bind with a selected analyte, and that selective response is used to confirm its presence in a sample. More complicated and specific immunoassays have been developed for particular applications, including fluorescence polarization, in vivo capture, and enzyme-lined immunospot (ELISPOT) assays.

Cross-reactivity is defined as the degree to which an antibody will bind to a substance other than its target, usually occurring when different compounds of similar structure can fit into an antibody’s “lock.” An immunoassay supplier will provide information about cross-reactivity for compounds similar to the target analyte. This information is presented in terms of the concentra¬tion of another compound that produces a detectable response (or interference) when the im¬munoassay kit is used. Sometimes, 100 to 1,000 times the concentration of another compound will be necessary to cause interference. The sample matrix also can produce interference. A good sampling and analysis plan will help manage interference by specifying rigorous sample prepara¬tion procedures and requiring confirmatory samples to assess whether the results of an analysis are biased.

Detection limits for immunoassays are often comparable to, or even lower than, those of conven¬tional analytical methods. The detection limits for immunoassay analytical techniques will vary according to test kit used, the target analytes, the sample matrix, and interfering substances. The immunoassay market has grown as both academia and industry have shifted from genomics to proteomics. Along with the immense potential of clinical diagnostics, the market for immuno¬logical assays is expected to see immense future growth.

Products with greater potential for growth include innovative reagents specifically designed to facilitate functional genomics and proteomics, including those used for immunoassays. Antibod¬ies, the primary reagent used in all immunoassays, continue to expand as more researchers gener¬ate antibodies to their proteins of interest. A vast array of tags and innovative tools for expressing proteins designed for antibody production have allowed immense growth in the technologies for their ultimate detection and diagnostic utility.

Primary screening for drug discovery depends heavily on immunological assays, including cell-based and high-content assays, assays for pertinent targets, and those involving fluorescent probes. The high-throughput needs of drug discovery and proteomics drove the adoption of microtiter plates in that 96- and 384-well plates have found a place in most labs. The continued push for speed helped to create momentum for miniaturization and the use of chips. As protein arrays find further development and use, their application for use in immunoassays will follow. The rapid rise of bead protocols demonstrates the need for more rapid immunological methods of investigation. With bead technologies maximizing their potential in the multiplex arena, researchers can exponentially multiply efficiency. The widespread acceptance of beads also stems from the adaptability of substrates with the rapid processing of flow cytometers.

In the world of diagnostics, nucleic acid-based tests directly compete with immunoassays in the market. Proteomics applications have witnessed the lion’s share of current investment dollars; they are expected to surpass such nucleic acid-based tools in the future. The present bottleneck is in validation within this clinical arena, but momentum is rising due to clear advances in detec¬tion sensitivity. Potential for growth also hinges upon the discovery of disease biomarkers, which would be amenable to immunoassay-based diagnostics for conditions including cardiovascular disease, cancer, prenatal screening, and Alzheimer’s disease.

Survey Introduction and Methodology

The 2008 Immunoassay Survey is designed to provide life science vendors of antibodies and other immunoassay products with information about the supplies that researchers are using and their plans for future purchases. Data were gathered from questions regarding the primary purposes for performing immunoassays, the types of immunoassay procedures that are currently performed, the suppliers preferred for those types of immunoassays and whether those suppliers would be recom¬mended to the responder’s colleagues, the number of replicates run per sample, the sample types and species studied, the types of detection methods used, the most important features of immuno¬assays, researcher purchasing plans in terms of product type and time frame, the number of sam¬ples analyzed per week and whether that number is expected to change, what size multiwell plate is used and how many plates are processed per week, the importance of control standards, whether immunoassay services are used, the problems and limitations encountered while using immunoas¬says, and questions concerning the use of multiplex immunoassay products. If survey participants reported using multiplex assays, questions concerning the type and number of analytes measured, the preferred suppliers of multiplex assay kits and an overall rating of multiplex immunoassay suppliers, whether those suppliers would be recommended to the responder’s colleagues, which instruments and bead-based multiplex assay products are used, and whether consumables and instruments are purchased from the same source were also asked. Survey participants were also asked to provide suggestions to suppliers on the design of next-generation immunoassay instru¬ments and reagents.

With this information, suppliers will be better able to focus product development in growing areas of current immunoassay research and to target their marketing and advertising campaigns in specific product areas, as well as direct customer attention to their specific immunoassay prod¬uct materials. As immunoassay technology develops, companies will be able to anticipate future product lines and set realistic goals for directing future product development.

The 2008 Immunoassay Survey consisted of 30 questions, one of which was open-ended. Eigh¬teen survey questions included “other” as an answer choice, providing an opportunity for survey participants to specify and elaborate their answers. Demographical information was gathered from 5 questions. The survey was administered online from March 13th - 28th, 2008, and the data tabulated and presented here.

I. Report Introduction
II. Technology Overview
III. Survey Introduction
IV. Discussion of Results
V. Conclusions and Recommendations
VI. Survey Results: a. Respondent Profile; b. Immunoassay Survey Data
VII. Appendix: Questionnaire
Demographic Questions: a. Country; b. Institution Type; c. Title; d. Key Areas of Research or Work; e. Purchasing Authority; f. Highest Professional Degree
Immunoassay Questions: 1. What is your primary purpose for performing immunoassays?; 2. What type(s) of enzyme immunoassay procedures do you currently use in your research or work? (Select all that apply); 3. Who are your preferred suppliers of the assay types you selected? Please select your first through third choices.(Separate question for each assay type); 4. How likely is it that you would recommend these companies to a friend or colleague? Please rate on a scale of 1-10.(Respondents will only rate the companies they selected); 1 = Not at all likely, 10 = Very likely
If performing multiplex assays, ask 5 through 12:: 5. Who is your preferred supplier of multiplex assay kits?; 6. Which multiplex instrument do you use?; 7. How likely is it that you would recommend Company X (from Q6,7) to a friend or col¬league? Please rate on a scale of 1-10.1 = Not at all likely, 10 = Very likely; 8. Which of the following bead-based multiplex assay products do you currently use?; 9. Do you utilize the consumables and the instrument from the same source?; 10. Please rate the following providers on their overall system of instruments, reagents and software products on a scale of 1 to 5.; 11. How many analytes do you typically measure within a single sample?; 12. How many replicates do you normally run per sample?; 13. Which of the following analyte type(s) do you measure using immunoassays? (Select all that apply); 14. What sample types/species are you studying in your research? (Select all that apply); 15. What type(s) of detection methods do you primarily use? (Select all that apply); 16. Please rate the following immunoassay features from 1 to 5 on a scale of importance to you. (1 = Least Important, 5 = Most Important); 17. Which of the following products and services are you planning to purchase and what is your purchasing timeframe? Within 3 months 3 - 9 months 9 - 12 months More than 12 months; 18. On average, how many samples do you analyze per week?; 19. How do you expect the total number of samples analyzed in your lab to change over the next 12 months?; 20. What size multiwell plate does your lab primarily use for immunoassays?; 21. On average, how many multiwell plates are processed in your lab per week?; 22. Please rate the importance of control standards being included in assay kits. Rate on a scale of 1 to 5 (1 = Not Important, 5 = Very Important).; 23. Does your lab use any of the following immunoassay services?; 24. What problems/limitations have you encountered in using immunoassays? (Select all that apply); 25. Do you have any suggestions you would like to provide to suppliers when designing next generation immunoassay instruments and reagents? (open-ended)

Immunoassays 2008: An End-User Survey Exploring Current Trends and Future

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