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Authors
Bolanaki, Myrto https://orcid.org/0000-0003-2032-8559
Möckel, Martin https://orcid.org/0000-0002-7691-3709
Dodoo, Christopher
Gilliam, Karen https://orcid.org/0000-0001-6325-0136
Robbins, Elissa https://orcid.org/0000-0003-1737-3228
Hata, D. Jane https://orcid.org/0000-0003-2512-351X
White, Bruce
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Funding
Funding for this research was provided by:
Roche Molecular Systems
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Article History
Received: 18 March 2025
Accepted: 17 June 2025
First Online: 14 July 2025
Declarations
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: Myrto Bolanaki, Jane Hata, and Bruce White have nothing to disclose. Martin Möckel has received consulting and speakers’ fees from Roche Diagnostics and Thermo Fisher Scientific. Christopher Dodoo, Karen Gilliam and Elissa Robbins are employees of Roche Diagnostics. Elissa Robbins is a stockholder of Roche Diagnostics.
: The study was conducted in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice Guidelines, and the Helsinki Declaration of 1964 and its later amendments. Institutional review board approval was obtained for each participating study site before study start (Institutional Ethical Review Board of the Charité-Universitätsmedizin Berlin (reference number: EA2/119/23) and Mayo Clinic Florida Institutional Review Board (reference number: 23-000144). All participants aged 18 years or older provided written informed consent; all participants aged less than 18 years had written informed consent provided on their behalf by a legal guardian.
