Introduction & Background

Introduction and background history

Background to centralized Assay Services at WPRC

When hormone assays were first introduced at the Primate Center in 1972, they were established, performed and maintained in the separate laboratories of the individual investigators. However, during the growth in both numbers of investigators and sophistication of research foci using hormone analyses in the late 1970’s and early 1980’s, such individual arrangements at the Primate Center led to unnecessary duplication, inadequate coordination of expertise, inadequate quality control and employment of different assay reagents to measure the same hormones. To eliminate this inefficiency and confusion, a centralized Assay Unit was formed under the direction of the then Associate Director, Dr. William D. Bridson, to coordinate hormone assay methodology and to fully enable the diverse research activities of investigators, based within or outside the Primate Center, who required hormone assay support. Dr. Jerry Robinson and Mr. Guenther Scheffler were also a part of this initial assay core group. The centralization of hormone assay facilities within the Primate Center proved highly successful and the laboratories received and have continued to receive national and international recognition for the volume, quality and diversity of endocrine measurements in nonhuman primates. Centralization has allowed Assay Services to acquire and to make available state-of the-art equipment and expertise for endocrine analysis. Dr. David H. Abbott (Ob/Gyn and WRPRC) succeeded Dr. Bridson as Head of Unit, in February 1991, and together with Dr. Toni E. Ziegler (Pyschology and WRPRC; Co-PI) in 1994, further enhanced the Unit into a fully integrated Research Service. Over these past 10 years, Dr. Ei Terasawa (Pediatrics and WRPRC; Co-I) has been one of the largest users of the Service component of Assay Services, has contributed significantly to Research and Development within Assay Services and, since June, 2002, Dr. Terasawa has become part of Assay’s Research and Development team. Dr. Ziegler assumed sole Directorship of Assay Services in July, 2005. Dr. Ziegler, Dr. Terasawa, Mr. Fritz Wegner, Mr. Dan Wittwer and Mr. Steve Jacoris are our current Assay Services members.

Organization and general operating procedures of Assay Services at WPRC

Assay Services functions as an integrated team. While each individual has clearly assigned individual responsibilities, there is frequently overlap between the functions performed by team members, so that Assay Services can provide flexible and dynamic responses to the research challenges posed by investigators. Assay Services operates under the overall administration and scientific leadership of Dr. Ziegler. Dr. Ziegler develops new methodology, targets new areas of development for hormone analysis and refines pre-analysis extraction techniques. Dr.Ziegler, in appropriate consultation with Assay Services’ personnel (Laboratory Manager II: Messrs. Wegner and Daniel J. Wittwer; Associate Research Specialist: Mr. Steven Jacoris) assess the need for development and improvement of assay methodology and reagents, and effect their implementation through regular discussions and bi-weekly meetings of Assay Services. Dr. Terasawa works with Mr. Wegner to develop assays for peptides relevant to neurobiology research projects in rhesus monkeys. Dr. Ziegler also assess the assay requests from individual investigators for (i) their scientific value, (ii) their need for development of procedures not established in Assay Services, and (iii) their appropriate sources of funding, before determining with Messrs. Wegner and Wittwer and the investigators (i) the applicable procedures, (ii) equipment, (iii) data analysis, (iv) numbers of determinations, (v) timetable and (vi) personnel required. The assay work is then performed such that Assay Services personnel with ("self-service"; see below), or without ("full service"; see below), technical assistance from the investigator’s research team, carry out the required procedures. Messrs. Wegner and Wittwer, in particular, are also engaged in the modification, improvement or development of procedures, when necessary. Furthermore, Messrs. Wegner and Wittwer are responsible for the day-to-day supervision of operations in their respective assay laboratories (Fig. 1), including maintenance of laboratory records and quality control data, weekly organization of use of Assay Services facilities by our own personnel and by investigators’ personnel, the scheduling of equipment service and use, and together with Mr. Jacoris, the maintenance of inventories of supplies, including all chemicals, assay reagents and components, and radioligands. Mr. Wegner is also responsible for (1) administrating the routine monitoring and training for, and compliance with Radiation Safety through his Radiation Users License and his 1999 appointment as Radiation Safety Officer for WRPRC, and (2) maintaining, improving and expanding the Assay Services Web page he established within the WPRC Web site. Mr. Wittwer is similarly responsible for Chemical Safety through maintenance and updating of Assay Services Chemical Hygiene Plan. Dr. Ziegler is responsible for Assay Services’ Biosafety Protocol (we operate at Biosafety Level 2 because of the safety concerns from working with macaque samples that have potential Herpes B virus contamination and fecal samples from free-living primates that have unknown potential health hazards) and IACUC Animal Care and Use Protocols for mouse bioassays and quality control sample collection. Dr. Ziegler is also responsible for Assay Services’ Controlled Substance Registration through the Wisconsin Department of Regulation and Licensing and the Drug Enforcement Administration, within the United States Department of Justice. The DEA registration allows Assay Services to hold anabolic steroids, such as testosterone, for reference hormone preparations, and Mr. Jacoris manages the day-to-day disbursements of controlled substances from the Assay Services’ narcotics safe. Such delegation of authority and organization of personnel is crucial for the efficient and safe function of the multifaceted, multi-user facility that constitutes Assay Services. Such organization of personnel also enhances efficient dissemination of information following assay determinations and the implementation of improved techniques, while minimizing the cost to investigators.

"Full service" and "Self-Service" assays and charges

Assay Services offers different levels of service support to meet the varied needs of investigators, so that assays can be performed, calculated and assessed either entirely by Assay Services personnel ("full service" charge to investigators) or by Assay Services personnel working together with research personnel (incurring a lower "self-service" charge to investigators), and both types of service can be requested from the investigator’s computer via our webpage. Both cost alternatives are available to all investigators, regardless of whether or not they are based at WPRC. We instigated the "self-service" option for all investigators to maximize efficiency of and access to Assay Services facilities. It has worked extremely well, is highly popular with investigators and has contributed to our high productivity. The popularity of "full" or "self-service" options is due to the flexibility it gives to investigators to have Assay Services personnel perform all or part of the assay procedures, and the lesser cost that accrues to the "self-service" option. Either option still involves Assay Services in procuring the assay reagents, maintaining them in ready-to-use preparations, fully supporting quality control and appropriateness of analysis, and disposing of materials (including radioactive and biologically hazardous waste). The "full service" option includes Assay Service personnel performing all procedures following receipt of the frozen samples. Without this ability to efficiently incorporate investigator personnel into assay output, as appropriate, we would not be able to maintain such a cost-effective and dynamic service. The inclusion of a "self-service" option within Assay Services, does not represent duplication of effort, but reflects a practical, efficient and cost-effective solution to the research needs of investigators. Given this operational structure, approximately 83% of the annual time and effort of all Assay Services personnel combined is taken up with the production of valid determinations for both the Service and the Research and Development components of Assay Services.

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