This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data.

Colli-Pee UAS device variants will be evaluated during this study

Comparison of DNA or RNA concentrations [ng/µL] measured using Qubit assays

• between different extraction methods;
• between different first-void urine volumes (10, 20, 40 mL);
• between different storage conditions (Day 0, Day 7, Day 14 at room temperature).

Comparison of protein concentrations measured using ELISA assays

• between different extraction methods;
• between different first-void urine volumes (10, 20, 40 mL);
• between different storage conditions (Day 0, Day 7, Day 14 at room temperature).

Comparison of cell-free DNA or RNA percentages (%) and profiles (graphical) measured using TapeStation assays

• between different extraction methods;
• between different first-void urine volumes (10, 20, 40 mL);
• between different storage conditions (Day 0, Day 7, Day 14 at room temperature).

Comparison of target detection measured using ddPCR assays [copies/µL]

• between different extraction methods;
• between different first-void urine volumes (10, 20, 40 mL];
• between different storage conditions (Day 0, Day 7, Day 14 at room temperature).

Comparison of target detection measured using ddPCR assays [positive, negative or copies/µL] in first-void urine samples from all study participants compared to blood testing using ddPCR. (Proof of concept study)