Perry, Michael D. http://orcid.org/0000-0002-7535-5899
Jones, Sophie http://orcid.org/0000-0002-7915-8921
Bertram, Alexander http://orcid.org/0000-0001-9401-0071
de Salazar, Adolfo http://orcid.org/0000-0002-4318-858X
Barrientos-Durán, Antonio http://orcid.org/0000-0003-2236-0958
Schiettekatte, Gilberte http://orcid.org/0000-0003-1874-8933
Lewinski, Michael
Arcenas, Rodney
Hansra, Avneet
Njoya, Merlin
García, Federico http://orcid.org/0000-0001-7611-781X
Funding for this research was provided by:
Roche Molecular Systems (Study number: RD003557)
Article History
Received: 4 July 2022
Accepted: 4 November 2022
First Online: 11 November 2022
Declarations
:
: The study was conducted in compliance with International Conference on Harmonisation (ICH) guidelines and Good Clinical Practice, and the protocol was approved by the Institutional Review Board (IRB) codes: 1559-N-18, UK NHS Health Research Authority Research Ethics Committee Reference Number – 18/EE/0334, 0175-N-19, CEIM/CEI Provincial de Granada, Comunidad Autónoma de Andalucía, Spain, EC UZA 18/47/545, Medical Association of Lower Saxony approval number Bo/32/2018.
: For AME, CMA, and PHW, no informed consent was deemed necessary according to the ethical committee due to use of remnant and de-identified samples for the study. For USC, verbal informed consent was obtained.
: Not required.
: ML, RA, AH, and MN are employees of Roche Molecular Systems. ML, RA, and AH report receiving stocks and stock options from Roche. MDP reports receiving funding from Roche for this study and an investigator-initiated study, as well as honoraria and funding to speak at and attend past meetings from Roche. FG reports receiving honoraria, grant, and advisory board support from Gilead Sciences, ViiV Healthcare, Janssen, Merck Sharp & Dohme, Theratechnologies, AbbVie, Werfen, Roche, Accelerate, and Menarini. GS reports receiving reagents from Roche to perform the testing during the study. AB reports receiving funding from Roche directly to their institution for sample analysis during the study. SJ reports receiving funding from Roche directly to their institution for this study. AdS and ABD have nothing to disclose.