Advice
The technology
The technology
Colli‑Pee (Novosanis) is a single-use urine collection device. It is designed to collect the first pass urine at any time of day, typically referring to the first 20 ml of urine flush because this can contain higher concentrations of DNA from human papillomavirus (HPV) and chlamydia compared with midstream urine (Pattyn et al. 2018; Wisniewski et al. 2008). It could also contain potential biomarkers for cancers such as cervical cancer and prostate cancer (Ducancelle et al. 2015; Theodorescu et al. 2008).
Colli‑Pee consists of a housing, a floater within a tube, and a cap for final sealing of the tube. When collecting urine, the collator tube is screwed onto the Colli‑Pee housing and the volume of urine needed is then collected. The device is then disconnected from the tube, which is then capped. The urine sample is sent to the lab. The collector tube can be prefilled with urine conservation medium, to allow preservation of DNA in urine. The company states that Colli‑Pee has variants for collecting first void urine from 4 ml to 45 ml, and currently 2 variants to collect either 10 ml or 20 ml of urine are CE marked.
Innovations
There are a wide range of containers used for collecting urine. Unlike other available methods, the Colli‑Pee device collects the exact volume of urine needed without the need to stop the stream of urine, because once the collection tube is full, the remainder of the stream will flow into the toilet. The device minimises the risk of spillage for the person when collecting urine and collects a standardised urine volume.
Current care pathway
Currently, urine testing is used to detect urinary tract infection and bacterial sexually transmitted infections (STIs). First void urine is collected for gonorrhoea and chlamydia testing in clinical practice. People are advised not to clean or wipe their genitals before passing urine. People are usually given a standard container to collect 10 ml or 20 ml of the first part of the urine stream (the first catch).
Cervical cancer can be caused by persistent infection with HPV. HPV detection in urine has recently been explored as an alternative means to identify people at increased risk of cervical cancer (Sargent et al. 2019).
Population, setting and intended user
Colli‑Pee would be used for first void urine collection. The company states that the device could be used for any indication when first void of urine is needed for testing. Currently, the device is mainly used for collecting samples to test bacterial and viral STIs and HPV infections in people presenting with symptoms. It could be also used for sample collection for detecting cancer biomarkers such as prostate cancer and has been included in some testing kits.
Colli‑Pee is intended to be used by people at home or in a clinic for urine collection. The urine sample is then sent to the laboratory for analysis. The company states that the Colli‑Pee device could be sent as a letter through the post.
Costs
Technology costs
The costs of the Colli-Pee device are:
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€2.58 for a 10 ml Colli‑Pee (equivalent to £2.22)
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€3.83 for a 10 ml Colli‑Pee with urine conservation medium (UCM) preservative (equivalent to £3.30)
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€3.61 for a 20 ml Colli‑Pee (equivalent to £3.11)
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€5.18 for a 20 ml Colli‑Pee with UCM preservative (equivalent to £4.47).
The UCM is prefilled in the tube and this is to stabilise DNA in the urine sample.
Costs of standard care
A standard plain white universal container without an additional urine collection product costs between £0.05 and £0.09. The company states that the cost of a cervical smear for detecting HPV is estimated to be around £6.00, and the cost of a swab for STIs is estimated to be about £2.00.
All stated costs do not include the reagent, the analysis and labour.