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
|Effective start/end date||9/1/19 → 9/1/20|
- Cepheid (244-RP)
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