Toxoplasma IgG Quality Control Testing Optimization

Abstract

This project explores a lean initiative of a multinational healthcare company related to a Toxoplasma IgG (protozoan parasite) quality control test. The objective was to reduce the test’s cycletime, material consumption and labor through an optimization of the testing scheme. A nested study design and a random effects model (also called variance components model) were utilized to assess the test method sources of variability. The test method was used to assess materials at various stages of production by evaluation of assay response and/or sample concentration. Validation runs showed that the test method performs in a manner that is consistent with the variance determined. A new testing scheme was set and its suitability for intended use was demonstrated. As a result, the total annual cost of the test was reduced from $45,736 to $33,320 or by 27 percent (%).