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Article History

Received: 5 June 2023

Accepted: 13 July 2023

First Online: 1 September 2023

Declarations

:

: HHM has research collaborations with Roche and Bio-Rad and serves on the advisory board for SeeGene. YCM has received research grant support to Johns Hopkins University from Hologic, Cepheid, Roche, ChemBio, Becton Dickinson, miDiagnostics, and has provided consultative feedback to Abbott on one occasion. MMH has received honoraria from Roche and GSK. All other authors, MHB, TS, AB, AM, CP, ZD, RER, YHH, SE, NGJ, PRC, BE, KPD, DD, and RJM, declare no competing interests.

: All study procedures will be performed in accordance with the relevant guidelines and regulations of the Declaration of Helsinki. Study participants will only engage in research activities after providing signed informed consent. The informed consent process will include the research coordinators explaining all study procedures to the potential participants and allowing sufficient time for reading the consent form and asking any questions the potential participants might have. This clinical trial will not enroll anyone under the age of 18. This clinical trial has been approved, and any future amendments will be approved, by the JHU institutional review board after discussion with the funder. The reference number is IRB00274090.

: Not applicable.

: The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.