| The 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 and the parallel line model. This method used the data generated from the current QC procedure.;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 and used to assess the accuracy of the two methods for determining the CSE potency.;For the Kinetic-QCL assay, the parallel line model resulted in better-predicted potency while the opposite was true for the Pyrogent-5000 assay. Based on the findings, the parallel line model was more accurate in determining the endotoxin potency for the Kinetic-QCL assay, and the current QC method was more accurate for the Pyrogent-5000 assay.;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. |
