Feasibility and acceptability of the Ellele Sampling Device for vaginal mucus collection suitable for molecular diagnostics

⇒ The Ellele Sampling Device uses a novel, inflatable, speculum-free design to achieve uniform circumferential contact with the vaginal mucosa, producing a distinct mucus-rich biological sample.⇒ In the Ellele-01 feasibility study, the device was strongly preferred by participants and clinicians, caused less discomfort than speculum examinations and consistently yielded high-integrity human and microbial DNA suitable for downstream molecular and genomic analyses. HOW MIGHT IT IMPACT ON HEALTHCARE IN THE FUTURE⇒ By improving tolerability and acceptability, the Ellele Sampling Device has the potential to increase participation in gynaecological screening and research, particularly among populations underserved by speculum-based examinations.⇒ The generation of a high-value vaginal sample capable of supporting integrated host-microbiome analyses may enable the development of new molecular diagnostics that reduce reliance on more invasive procedures.⇒ Its simple deployment and compatibility with molecular workflows support potential use across diverse settings, including community clinics, outreach programmes and research environments.Protected by copyright, including for uses related to text and data mining, AI training, and similar technologies..