The goal of this feasibility study is to evaluate a new sample preparator called See.d. After blood processing the instrument will produce a set of slides and a tube of plasma. These outputs could be used in further analysis in liquid biopsy applications.
This feasibility study aims at the evaluation of a new instrument called See.d , to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides and reagents, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection). Blood samples will be collected from healthy volunteers and will be used to test See.d performances. Moreover the possibility of develop a new version of the instrument with increased processing capability and to develop and optimize analytical protocols for liquid biopsy applications will be evaluated as exploratory objectives. The only study procedure will be the collection of a blood sample from each participants; during this study 200 participants will be enrolled. For its feasibility nature, no formal statistics has been planned for this study.
Study Type
OBSERVATIONAL
Enrollment
200
Ospedale San Raffaele
Milan, Italy
RECRUITINGSBS slides stability
Evaluation of the area of adhered cell nuclei on SBS slides
Time frame: 1 day (at the blood draw)
Reagents stability
Evaluation of total adhered cell count on SBS slides
Time frame: 1 day (at the blood draw)
cfDNA quality control
Evaluation of the ratio between cfDNA and genomic contaminant DNA
Time frame: 1 day (at the blood draw)
Feasibility of staining on slides produced by See.d
Qualitative assessment of staining positivity
Time frame: 1 day (at the blood draw)
Feasibility of using See.d SBS slides for subsequent analysis
Recovery of mock-Circulating Tumor Cells (CTCs)
Time frame: 1 day (at the blood draw)
Feasibility of using See.d plasma for subsequent analysis
Recovery of spiked reference DNA
Time frame: 1 day (at the blood draw)
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