Participants selected to continue with the trial were asked to input an address through the digital platform, to be sent a DBS sample collection kit. The DBS sample collection kit used in the Delta Trial was a Conformité Européene-marked device under Article 22 of the Medical Device Regulation 2017/745 and contained relevant materials and instructions to allow participants to complete and submit DBS samples.
A standardized MS-based targeted proteomic biomarker screening method, based on previously published work [48 (link),91 (link)], was developed for the Delta Trial. For this method, 203 candidate peptides representing 120 proteins were selected for inclusion, in many cases based on their previous association with psychiatric disorders, including depression, BD, and schizophrenia [91 (link)]. These proteins were first extracted and digested from the DBS samples [48 (link)], and then, unique surrogate peptides representing candidate proteins were monitored through multiple reaction monitoring using an Agilent 1290 liquid chromatography system coupled with an Agilent 6495 Triple Quadrupole Mass Spectrometer.
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