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Article History

Received: 22 December 2020

Accepted: 26 April 2021

First Online: 18 May 2021

Declarations

:

: This study received Institutional Review Board (IRB) approval for each of the seven U.S. sites, which included Emory University/Children’s Healthcare of Atlanta, Children’s Mercy Hospital, Children’s Hospital of Los Angeles, Nationwide Children’s Hospital, Texas Children’s Hospital, Rhode Island Hospital, and Primary Children’s Hospital. The IRB at one site (Emory University, IRB00096348) provided waiver of informed consent for clinical investigations involving no more than minimal risk to human subjects (ExternalRef removed). Children at all other sites were prospectively enrolled following informed consent and assent as indicated for age. All methods were carried out in accordance with relevant guidelines and regulations.

: Not applicable.

: This study was designed and funded by BioFire Diagnostics. MJ, EO, JB, and KMB are employees of BioFire Diagnostics. CAR, NK, JY, CRM, JDB, AL, JD, KCC, AJB, JAD, and LAH received research support to their respective institutions from BioFire Diagnostics. AJB has intellectual property licensed to BioFire Diagnostics and receives royalties through the University of Utah. AJB collaborates with BioFire Diagnostics on federally funded studies has received research funding from BioFire Diagnostics for investigator-initiated research. AJB has acted as a paid advisor to BioFire Diagnostics.