Potential conflicts of interest. A. J. M. serves on the advisory boards for Merck, VenatoRX, and Qpex Biopharma. E. W. reports consulting fees from bioMerieux; honoraria from AbbVie Inc, Astellas Pharma, Ferring Pharmaceuticals, Melinta Therapeutics, and Shionogi Inc; participation on a data and safety monitoring board or advisory board for Venatorx Pharmaceuticals; and is an employee of Roche Diagnostics Corporation. All authors serve as unpaid volunteers for the Clinical Laboratory and Standards Institute. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.