2.3. Overview of study design

The primary aim of this study was to assess key analytical performance indicators for the AQT90 hCG assay including repeatability, within-laboratory precision, hook effect, carryover and accuracy. A secondary aim was to get a preliminary appreciation of the variability in results that may be seen in an institution or an organization that has multiple analyzers and reagent lots in use simultaneously. To achieve the secondary aim, sample analysis was completed using two different lots of Solution Packs, with the change from the first to the second lot having been made mid-way during the study. Limited reagent availability precluded the use of two different lots of Test Kits for the study. To achieve the secondary aim, sample analysis was also performed using a combination of two different AQT90 analyzers whenever possible. Experiments that only used a single analyzer are noted in the text as having done so. For the method comparison study, samples were randomly run on one or the other analyzer with roughly 20 samples being run on each.