MATERIALS AND METHODSThe sensitivity component of the study was performed in the Development Laboratory at RocheMolecular Diagnostics International, Rotkreuz, Switzerland, from July to August 2017. All other studycomponents were done in Johannesburg, South Africa, from May to September 2017. The HumanResearch Ethics Committee (Medical) of the University of the Witwatersrand (no. M160617) and theDistrict Research Committee of Johannesburg approved the study. The health workers and laboratorytechnicians in the usability assessment gave written informed consent, as did patients who providedblood samples. Test results were not used for patient care. All analyses were done using SAS JMP v12.