(Scanned from the Applicant's Description): The goal of the proposed research is to develop two prototype analyzers interfaced with automated microwell plate readers for rapid screening of human growth hormone (hGH) by Surface Enhanced Raman ImmunoAssay (SERIA). The first prototype will be placed in a clinical setting. This study will include retrospective and prospective analyses of patients who have been evaluated for growth hormone secretory abnormalities. We will cross validate this work with a comparison to conventional radioimmunoassay measurements. This will provide us with a credible validation and a beginning for FDA approval. The second prototype will be developed for system optimization to evaluate the engineering and assay methodology. The system enhancement will involve a factor analysis of the controllable factors of the technique. These will include incubation time, sample size, temperature, humidity, plate design, integration time, laser power, plate translation speed, and chemometric parameters. The optimization will be performed with respect to accuracy, precision, and total assay time. During the course of the project any significant improvements will be shared with the first study group for adoption into their clinical studies. The results of these two parallel studies will be used to position our group to enter into the hGH monitoring market.
The hGH analyzer instruments developed from this work will find wide applicability in clinical settings devoted to growth hormone study as a replacement for the high cost/slow turnaround time methods currently in use. This instrument will also be useful in research settings in which large numbers of samples must be processed.
