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

Project: Research project

Description

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
StatusActive
Effective start/end date9/1/199/1/20

Funding

  • Cepheid (244-RP)