Analytical reliability and patient experience of a microblade-based self-collection device for reproductive hormone monitoring: a paired-sample pilot study.

RESEARCH QUESTION: Can a microblade-based self-collection device (Tasso+, Tasso, USA) provide analytically reliable measurements of key reproductive hormones compared with standard venous sampling under controlled conditions, and does it improve patient experience during IVF monitoring?

DESIGN: A multicentre, pilot, paired-sample study was conducted in 39 women undergoing IVF treatment. Paired venous and Tasso+ samples were collected during the same clinical visit and anti-Mullerian hormone (AMH), oestradiol and progesterone concentrations were analysed at 0, 24, 48 and 72 h under controlled storage at 4°C. Agreement was assessed using Pearson correlation coefficients, intra-class correlation coefficients (ICC) and Bland-Altman analyses. Patient experience was evaluated using a structured questionnaire.

RESULTS: Hormone concentrations obtained via Tasso+ showed excellent agreement with venous sampling across all analytes and time points (Pearson's r = 0.948-0.998, ICC = 0.948-0.998). AMH and oestradiol remained stable for up to 72 h at 4°C, with minimal bias and narrow limits of agreement. Progesterone maintained high agreement at 24 h but showed increasing dispersion at 48 and 72 h. Patient-reported experience was favourable across all domains, with overall mean scores ranging from 7.80 to 8.18 on a 10-point Likert scale.

CONCLUSIONS: Under controlled clinical and laboratory conditions, Tasso+ provides analytically reliable measurements of AMH, oestradiol and progesterone with favourable patient acceptability. AMH and oestradiol concentrations remained stable for up to 72 h at 4°C, whereas progesterone samples should ideally be analysed within 24 h for clinical decision making. These findings support the further evaluation of self-collection devices as complementary tools in patient-centred IVF monitoring pathways.