Colli-Pee for first void urine collection

The technology described in this briefing is Colli‑Pee. It is intended to be used for first void urine collection.

The innovative aspects are that Colli‑Pee collects first void urine, without the person needing to interrupt the flow of urine and standardises the volume of urine collected.

The intended place in therapy would be as an alternative to sterile urine collection containers for detecting human papillomavirus (HPV), sexually transmitted infections (STIs) or cancer biomarkers and for other sample collection methods such as cervical smear or self-sampling vaginal swabs in people presenting with symptoms. The experts note that the device might have particular benefits to specific groups of people, such as those who are less able to aim their urine or people with cognitive impairment.

The main points from the evidence summarised in this briefing are from 1 randomised comparative study, 2 prospective cohort studies and 2 cross-sectional studies including a total of 984 people who were at high risk of HPV or STIs. They show that HPV or STI detection rates were similar using urine samples collected using Colli‑Pee compared with other sampling methods including self-collected vaginal samples, home-collected urine samples (with Colli‑Pee) and samples collected in a clinic. Sensitivity for cervical intraepithelial neoplasia grade 2+ (CIN2+) with the SPF10 assay system using samples by cervical smear, cervicovaginal brush and Colli‑Pee was 100%, 100% and 95% respectively. Similar sensitivities were found for CIN2+ and CIN3+ using urine samples and vaginal samples.

Key uncertainty is that that there is limited published evidence, and further comparative diagnostic studies on clinical accuracy compared with standard NHS practice would be useful.

The cost of Colli‑Pee depends on the variant (for example the volume of urine collection) with or without urine conservation medium (UCM). It ranges from £2.22 for 10 ml without UCM to £4.47 for 20 ml with UCM (excluding VAT). The cost of an HPV smear is estimated to be £6.00 and a swab for an STI is estimated to be £2.00. All stated costs do not include the reagent, the analysis and labour.