The primary function of the GCRC Core Laboratory is to provide technical support for sophisticated clinical research assays.

The Johns Hopkins Bayview Medical Center General Clinical Reseacrh Center Core Laboratory currently supports clinical research protocols carried out by investigators on both the Bayview campus and downtown (Hopkins Hospital) campus. In addition, we are the Immunoassay Core Laboratory for the nascent GCRC at the University of Maryland and carry out specialized immunoassays for investigators at the NIH Clinical Center in Bethesda, MD.

Within this context, the Core Laboratory supports GCRC approved protocols by providing facilities, technical experience and training for non-routine blood and urine biochemical analyses. To accomplish this, the Core has the following specific aims: (1) to provide state of the art facilities and technical support to characterize biological samples by immunoassays; and (2) the development or validation of new methods for this purpose.

Currently employed assays include: insulin, glucose, creatinine, insulin-like growth factor I, leptin, the hormones luteinizing hormone, follicle stimulating hormone, and thyroid stimulating hormone, markers for bone metabolism such as carboxy-terminal propeptides and N-telopeptides of type I collagen, osteocalcin, bone alkaline phosphatase, and urine deoxy-pyridinoline crosslinks. These assays are clinical tools for the study of aging effects, and of diseases such as diabetes mellitus and osteoporosis. These assays are also useful clinically for tracking therapeutic outcomes.

The Core has two full time technicians and a director. The personnel of the Core have many years of combined laboratory experience in the mechanics of clinical assays and in prioritizing access to existing Core resources. It is a goal of the Core to not only promote the investigator' s ability to obtain accurate clinical data, but to also develop a critical understanding of the mechanics of assays and their potential limitations. Towards this end the Core Laboratory has a policy of maintaining a continuous dialogue with the investigators throughout the entire course of a project from initial experimental design to final data analysis.

Assay requests are approved following NIH guidelines on GCRC Core Laboratories. Briefly, these guidelines require a minimum of three distinct GCRC approved protocols/investigators requesting a given assay. These protocols can be "Core Lab only" protocols that do not require GCRC inpatient, outpatient, Nursing, CDMAS or exercise facilities. However, all assay requests must arise from protocols that have been reviewed by the GCRC Advisory Committee. The proper forms for submitting protocols to the GCRC Advisory Committee can be found at For Investigators. If you are interested in finding out whether the Core Laboratory can aid your clinical studies, please contact the Core Laboratory Director, Neal S. Fedarko 550-2632, 550-1958 or by e-mail at: ndarko@jhmi.edu.