Mazur, Rhonda M.2024-03-112024-03-112004-05http://hdl.handle.net/11603/31899The purpose of this thesis is to analyze methods used to assign the endotoxin potency for the Control Standard Endotoxin (CSE) used in endotoxin detection test kits. The procedure currently used by the Quality Control Department involves making a dilution series from four vials of CSE, determining the potency for each dilution independently, assigning a single potency to each vial assayed and then averaging the potency of the four vials of CSE and comparing it to the potency of the Reference Standard .Endotoxin (RSE). Through such a procedure, the overall stated potency for the four vials may be an under or over estimation. The parallel line model was an alternative method to analyze the standard curves and possibly achieve a more accurate potency determination for the CSE. This method compared the parallelism between the RSE curve and the CSE curve and used the differences in the calculated Y-intercept to determine the endotoxin potency. This method used the data generated from the current QC procedure. Once the potency of the CSE for both methods was determined, a technique was developed to evaluate the accuracy of the endotoxin measurements performed using the assigned potencies. The difference between the known concentrations of the RSE and the predicted concentration of the RSE at each dilution point was referred to as the residual. The residuals were used to assess the accuracy of the two methods for determining the CSE potency. Upon analysis, for the Kinetic-QCL assay, the parallel line model resulted in better-predicted potency due to the smaller sum squares compared to that of the current QC method. Based on the -findings, the parallel line model was more accurate in determining the endotoxin potency for the Kinetic-QCL assay. The opposite was true for the Pyrogent-5000 assay. For this assay, the current QC method resulted in a better predicted potency due to the smaller sum of squares compared to that of the parallel line model. The residual analysis concluded the sum of squares for the QC method was lower in nearly all cases compared to that of the parallel line model. On average, the assigned potency of the CSE based on the parallel line model over predicted the endotoxin. Based on the study's findings, the endotoxin for the Pyrogent- 5000 assay should be determined by the current QC method. During the course of data analysis, it was observed that, on occasion, both methods result in atypical sum of squares. In these instances, it was determined that for both assays if the overall starting potency of the CSE was lowered, a better sum of squares could be obtained, which in turn resulted in better predictive accuracy.153 pagesen-USText