FIG. 1.

Ruggedness of the HPV 9 IgG serology assay to VLP-microsphere lots, operators, and secondary detection antibody lots. A panel of 56 samples was tested over a period of 3 weeks by 2 analysts using 3 VLP-microsphere lots and 2 different mouse anti-human IgG lots (HP6043). The least-squares (LS) mean antibody (Ab) concentrations (mMU/ml) of the 3 conditions were analyzed for the ruggedness of the assay. Error bars represent the ±1.3-fold design goal. All conditions were within a ±1.3-fold difference, indicating that the assay should be acceptably rugged for use in clinical testing.