244-RP: Reproducibility Evaluation of the Xpert MTB/XDR Assay

1.1 Study Overview This is a blinded study using a 5-member panel which will be evaluated based upon the following variables: • Site (Instrument): 3 testing sites (sites site will use GeneXpert Dx platform) • Lot: 3 kit lots (each lot will be used for 2 days) • Day: 6 days of testing total (not necessarily consecutive however both operators must be available to test on the same day) • Operators: 2 per site (one with previous experience and one with little to no experience) • Run: 3 runs per operator/per day (1 panel = 5 panel members ) for a total of 15 samples per operator/per day • Rep: 1 rep per run