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Article History

Received: 12 May 2025

Accepted: 27 June 2025

First Online: 2 August 2025

Declarations

:

: The protocol for the parent study was reviewed and approved by each site’s institutional review board (Advarra IRB for most sites, University of Pennsylvania IRB, and Louisiana State University Health Sciences Center IRB for their respective sites) and in accordance with the Declaration of Helsinki. All study participants provided informed consent. In addition, minors provided assent and informed consent of a parent or legal guardian prior to participating in the study. The secondary analysis in this article is from the data collected in the parent study.

: not applicable.

: BVDP reports receiving grants to her institution and/or consulting/honorarium fees from Abbott Rapid Diagnostics, AmplifiDx, BD Lifesciences, BioMérieux, binx health, Cepheid, Hologic, Magic Lifesciences, Preventx, Roche, Sherlock and Visby. RL reports receiving grants to her institution and/or consulting honorarium fees from Abbott, BD Lifesciences, BioMerieux, Cepheid, Chembio, CovarsaDx, Hologic, OrthoQuidel, Roche, Sherlock, and Visby. IN, LC, JB, LP and AW report receiving support to her/his institution from Cepheid in support of this project. SY reports receiving support to his institution from Abbott Molecular Diagnostics, BD Lifesciences, Cepheid, Hologic, miDiagnostic, Roche and Sherlock. LP reports receiving support to his institution from Cepheid in support of this project. CH and AR are employed by Cepheid.