Funding for this research was provided by:
National Institute of Allergy and Infectious Diseases (R01AI116324)
Thrasher Research Fund (12647)
Center for AIDS Research, Johns Hopkins University (P30AI094189)
Centers for Disease Control and Prevention (5U2GPS001930-05)
Received: 23 October 2020
Accepted: 15 January 2021
First Online: 26 January 2021
Ethics approval and consent to participate
: The LYNX Hospital and NSEBA studies were approved by the Institutional Review Boards at Macha Research Trust, the Johns Hopkins Bloomberg School of Public Health, the Ministry of Health in Zambia (LYNX Hospital study), and the National Health Research Authority in Zambia (NSEBA study). All parents or guardians provided written informed consent for participation in the study. As the LYNX test was not approved for clinical use in Zambia, the results were not provided to caregivers or healthcare providers in either study.
: Not applicable.
: AKA, MJF, and RE were involved in the development, testing, and manufacturing/quality assurance of the LYNX instrument and assay. KMP is the President of the Northwestern Global Health Foundation, a nonprofit organization that funded the development of the LYNX assay and instrument. All other authors have no conflicts to declare.